Trial Outcomes & Findings for T Cells Expressing a Fully-human AntiCD19 Chimeric Antigen Receptor for Treating B-cell Malignancies (NCT NCT02659943)

Last Updated: 2023-04-19

Results Overview

Percentage of participants enrolled who received treatment with Chimeric Antigen Receptor (CAR) T cells, Fludarabine and cyclophosphamide.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

27 participants

Primary outcome timeframe

4-5 weeks after the first dose

Results posted on

2023-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only LEVEL 1 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10\^6 CAR T cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only LEVEL 2 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells LEVEL 2 followed by LEVEL 3 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only LEVEL 3 - participants who received - 6x10\^6 Chimeric Antigen Receptor (CAR) T cells only	Participants Enrolled But Not Treated Participants who were enrolled but not treated.
Overall Study STARTED	3	2	1	4	2	9	6
Overall Study COMPLETED	2	0	0	1	0	4	0
Overall Study NOT COMPLETED	1	2	1	3	2	5	6

Reasons for withdrawal

Reasons for withdrawal
Measure	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only LEVEL 1 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10\^6 CAR T cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only LEVEL 2 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells LEVEL 2 followed by LEVEL 3 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only LEVEL 3 - participants who received - 6x10\^6 Chimeric Antigen Receptor (CAR) T cells only	Participants Enrolled But Not Treated Participants who were enrolled but not treated.
Overall Study Switched to alternative treatment	1	1	0	2	1	0	1
Overall Study Disease progression on study	0	1	1	1	1	4	0
Overall Study Patient's condition per principal investigator	0	0	0	0	0	1	0
Overall Study Ineligible	0	0	0	0	0	0	1
Overall Study No longer meets eligibility	0	0	0	0	0	0	1
Overall Study No treatment, per protocol	0	0	0	0	0	0	3

Baseline Characteristics

T Cells Expressing a Fully-human AntiCD19 Chimeric Antigen Receptor for Treating B-cell Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only n=3 Participants LEVEL 1 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells n=2 Participants LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10\^6 CAR T cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=1 Participants LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only n=4 Participants LEVEL 2 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=2 Participants LEVEL 2 followed by LEVEL 3 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only n=9 Participants LEVEL 3 - participants who received - 6x10\^6 Chimeric Antigen Receptor (CAR) T cells only	Participants Enrolled But Not Treated n=6 Participants Participants who were enrolled but not treated.	Total n=27 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	7 Participants n=10 Participants	6 Participants n=115 Participants	25 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	8 Participants n=10 Participants	6 Participants n=115 Participants	25 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	6 Participants n=10 Participants	4 Participants n=115 Participants	18 Participants n=24 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	2 Participants n=115 Participants	9 Participants n=24 Participants
Age, Continuous	55.6 years STANDARD_DEVIATION 10.14 • n=5 Participants	50.35 years STANDARD_DEVIATION 3.04 • n=7 Participants	68.6 years STANDARD_DEVIATION 0 • n=5 Participants	57.2 years STANDARD_DEVIATION 8.61 • n=4 Participants	65 years STANDARD_DEVIATION 5.09 • n=21 Participants	57.11 years STANDARD_DEVIATION 10.8 • n=10 Participants	52.98 years STANDARD_DEVIATION 16.32 • n=115 Participants	56.55 years STANDARD_DEVIATION 11.05 • n=24 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=10 Participants	2 Participants n=115 Participants	11 Participants n=24 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=10 Participants	4 Participants n=115 Participants	16 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants
Region of Enrollment United States	3 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants	2 participants n=21 Participants	9 participants n=10 Participants	6 participants n=115 Participants	27 participants n=24 Participants
Prior Lines of Therapy 1 Line of therapy	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=24 Participants
Prior Lines of Therapy 2 Lines of therapy	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	1 Participants n=115 Participants	6 Participants n=24 Participants
Prior Lines of Therapy 3 Lines of therapy	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	4 Participants n=24 Participants
Prior Lines of Therapy 4 Lines of therapy	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=10 Participants	0 Participants n=115 Participants	7 Participants n=24 Participants
Prior Lines of Therapy 5 Lines of therapy	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	3 Participants n=24 Participants
Prior Lines of Therapy 6 Lines of therapy	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=24 Participants
Prior Lines of Therapy 9 Lines of therapy	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=24 Participants
Lymphoma Type DLBCL	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=10 Participants	3 Participants n=115 Participants	10 Participants n=24 Participants
Lymphoma Type DLBCL transformed from follicular lymphoma	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=24 Participants
Lymphoma Type DLBCL, double-hit	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=24 Participants
Lymphoma Type DLBCL, triple-hit	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=24 Participants
Lymphoma Type Mantle-cell lymphoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	3 Participants n=24 Participants
Lymphoma Type Follicular lymphoma	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=24 Participants
Lymphoma Type Burkitt lymphoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=24 Participants
Lymphoma Type CLL/DLBCL	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants
Lymphoma Type ALL	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=24 Participants

PRIMARY outcome

Timeframe: 4-5 weeks after the first dose

Population: Data is combined for this outcome measure because it is not possible to draw firm conclusions from the small number of participants in each dose level; the data drawn from the overall participant population through the course of the trial is much more meaningful and conclusive. 26/27 participants were analyzed because one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.

Percentage of participants enrolled who received treatment with Chimeric Antigen Receptor (CAR) T cells, Fludarabine and cyclophosphamide.

Outcome measures

Outcome measures
Measure	All Participants n=26 Participants All participants who received Biological/Vaccine: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells Dose-escalation trial starting dose: 0.66x10\^6 CAR+ T cells/kg (weight-based dosing) (up to a maximum dose of 18x10\^6 CAR+ T cells/kg) infuse on day 0 Drug: Cyclophosphamide 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Drug: Fludarabine 30 mg/m\^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10\^6 CAR T cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only LEVEL 2 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells LEVEL 2 followed by LEVEL 3 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only LEVEL 3 - participants who received - 6x10\^6 Chimeric Antigen Receptor (CAR) T cells only
Percentage of Enrolled Participants Who Actually Get Treated	76.9 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 30 days post Chimeric Antigen Receptor (CAR) T-cells up to 5 years

Population: 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.

Response was assessed by the Revised Response Criteria for Malignant Lymphoma, and Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification. Complete Remission is complete disappearance of all detectable clinical evidence of disease. Partial Remission is ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. Progressive Disease is ≥50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Biological/Vaccine: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells Dose-escalation trial starting dose: 0.66x10\^6 CAR+ T cells/kg (weight-based dosing) (up to a maximum dose of 18x10\^6 CAR+ T cells/kg) infuse on day 0 Drug: Cyclophosphamide 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Drug: Fludarabine 30 mg/m\^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells n=2 Participants LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10\^6 CAR T cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=1 Participants LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only n=4 Participants LEVEL 2 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=2 Participants LEVEL 2 followed by LEVEL 3 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only n=9 Participants LEVEL 3 - participants who received - 6x10\^6 Chimeric Antigen Receptor (CAR) T cells only
Number of Participants Who Had a Best Response of Complete Remission (CR), Partial Remission (PR), Stable Disease (SD), and Progressive Disease (PD) Complete Remission After First Re-Treatment	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Had a Best Response of Complete Remission (CR), Partial Remission (PR), Stable Disease (SD), and Progressive Disease (PD) Complete Remission After Second Re-Treatment	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Had a Best Response of Complete Remission (CR), Partial Remission (PR), Stable Disease (SD), and Progressive Disease (PD) Partial Remission After Second Re-Treatment	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Who Had a Best Response of Complete Remission (CR), Partial Remission (PR), Stable Disease (SD), and Progressive Disease (PD) Stable Disease After First Re-Treatment	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Who Had a Best Response of Complete Remission (CR), Partial Remission (PR), Stable Disease (SD), and Progressive Disease (PD) Stable Disease After Second Re-Treatment	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Who Had a Best Response of Complete Remission (CR), Partial Remission (PR), Stable Disease (SD), and Progressive Disease (PD) Stable Disease After Third Re-Treatment	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Who Had a Best Response of Complete Remission (CR), Partial Remission (PR), Stable Disease (SD), and Progressive Disease (PD) Progressive Disease After Second Re-Treatment	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Response duration is the time from first documentation of response, which is one month after cell infusion in all participants, until progression, initiation of off-study treatment or the last documentation on ongoing response, approx. one month -5 years.

Population: No participants were analyzed in the participants enrolled but not treated Arm/Group, thus the table is not included.

Best Response defined as the first documentation of response was assessed by the Revised Response Criteria for Malignant Lymphoma, and Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Biological/Vaccine: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells Dose-escalation trial starting dose: 0.66x10\^6 CAR+ T cells/kg (weight-based dosing) (up to a maximum dose of 18x10\^6 CAR+ T cells/kg) infuse on day 0 Drug: Cyclophosphamide 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Drug: Fludarabine 30 mg/m\^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells n=2 Participants LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10\^6 CAR T cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=1 Participants LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only n=4 Participants LEVEL 2 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=2 Participants LEVEL 2 followed by LEVEL 3 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only n=9 Participants LEVEL 3 - participants who received - 6x10\^6 Chimeric Antigen Receptor (CAR) T cells only
Number of Participants With a Duration of Best Response in Months Stable Disease - 1 Month After First Re-Treatment	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With a Duration of Best Response in Months Stable Disease - 2 Months (first of three treatments)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With a Duration of Best Response in Months Partial Remission - 2 months	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With a Duration of Best Response in Months Partial Remission - 3 Months	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With a Duration of Best Response in Months Complete Remission - 4 Months (first of two treatments)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With a Duration of Best Response in Months Progressive Disease - After first Re-treatment	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With a Duration of Best Response in Months Complete Remission - 40 Months (first of two treatments)	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With a Duration of Best Response in Months Complete Remission - 6 Months	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With a Duration of Best Response in Months Complete Remission - 6 Months (first of two treatments)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With a Duration of Best Response in Months Complete Remission - 29+ Months	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With a Duration of Best Response in Months Complete Remission - 35+ Months	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants
Number of Participants With a Duration of Best Response in Months Complete Remission - 45+ Months	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With a Duration of Best Response in Months Stable Disease - 1 Month	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With a Duration of Best Response in Months Stable Disease - 1 Month (first of two treatments)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With a Duration of Best Response in Months Stable Disease - 2 Months After Second Re-Treatment	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With a Duration of Best Response in Months Partial Remission - 1 Month After First Re-Treatment	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With a Duration of Best Response in Months Complete Remission - 5 Months After First Re-Treatment	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With a Duration of Best Response in Months Progressive Disease	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 49 months and 19 days.

Adverse Events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening or disabling, and Grade 5 is fatal.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Biological/Vaccine: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells Dose-escalation trial starting dose: 0.66x10\^6 CAR+ T cells/kg (weight-based dosing) (up to a maximum dose of 18x10\^6 CAR+ T cells/kg) infuse on day 0 Drug: Cyclophosphamide 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Drug: Fludarabine 30 mg/m\^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells n=2 Participants LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10\^6 CAR T cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=1 Participants LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only n=4 Participants LEVEL 2 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=2 Participants LEVEL 2 followed by LEVEL 3 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only n=9 Participants LEVEL 3 - participants who received - 6x10\^6 Chimeric Antigen Receptor (CAR) T cells only
Number of Participants That Had Any Grade 2, 3, 4 and 5 Adverse Events < Grade 2	2 Adverse events	2 Adverse events	1 Adverse events	3 Adverse events	2 Adverse events	6 Adverse events
Number of Participants That Had Any Grade 2, 3, 4 and 5 Adverse Events Grade 2	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events
Number of Participants That Had Any Grade 2, 3, 4 and 5 Adverse Events Grade 5	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of Participants That Had Any Grade 2, 3, 4 and 5 Adverse Events Grade 3	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of Participants That Had Any Grade 2, 3, 4 and 5 Adverse Events Grade 4	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events

SECONDARY outcome

Timeframe: All post-infusion time-points up to at least 2 months after infusion, and CAR+ T cell analysis will continue until the CAR+ T cell level drops to undetectable levels unless a stable low level of CAR+ T cells is present at more than 3 years after infusion.

A quantitative polymerase chain reaction (PCR) assay or a flow cytometry assay will be used to quantitate Chimeric Antigen Receptor (CAR) + T cells. The absolute number of CAR+ peripheral blood mononuclear cells (PBMC) will be estimated by multiplying the percentage of CAR+ PBMC determined by PCR by the absolute number of lymphocytes plus monocytes per microliter of blood.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Biological/Vaccine: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells Dose-escalation trial starting dose: 0.66x10\^6 CAR+ T cells/kg (weight-based dosing) (up to a maximum dose of 18x10\^6 CAR+ T cells/kg) infuse on day 0 Drug: Cyclophosphamide 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Drug: Fludarabine 30 mg/m\^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells n=2 Participants LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10\^6 CAR T cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=1 Participants LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only n=4 Participants LEVEL 2 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=2 Participants LEVEL 2 followed by LEVEL 3 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only n=9 Participants LEVEL 3 - participants who received - 6x10\^6 Chimeric Antigen Receptor (CAR) T cells only
Median Peak Chimeric Antigen Receptor (CAR) T Cells Level for Participants Treated	42 CAR+cell/microliter of blood Interval 31.0 to 606.0	6 CAR+cell/microliter of blood Interval 1.0 to 33.0	4 CAR+cell/microliter of blood Not available for second cell infusion.	36 CAR+cell/microliter of blood Interval 11.0 to 1258.0	6 CAR+cell/microliter of blood Interval 0.0 to 25.0	87 CAR+cell/microliter of blood Interval 28.0 to 2216.0

SECONDARY outcome

Timeframe: Participants could receive subsequent cell infusions any time 1 month after CAR T-cell infusion until 5 years after cell infusion.

Number of participants who had a second or third Infusion Chimeric Antigen Receptor (CAR)+ T cells. Participants were eligible for a subsequent CAR T-cell infusion if the response at one month after CAR T-cell infusion was partial remission (PR) or stable disease (SD). Participants could also receive a subsequent CAR T-cell infusion if the response was complete remission (CR) but the malignancy later relapsed. CR, PR, and SD was assessed by the Revised Response Criteria for Malignant Lymphoma, and Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification. Complete Remission is complete disappearance of all detectable clinical evidence of disease. Partial Remission is ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Biological/Vaccine: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells Dose-escalation trial starting dose: 0.66x10\^6 CAR+ T cells/kg (weight-based dosing) (up to a maximum dose of 18x10\^6 CAR+ T cells/kg) infuse on day 0 Drug: Cyclophosphamide 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Drug: Fludarabine 30 mg/m\^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells n=2 Participants LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10\^6 CAR T cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=1 Participants LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only n=4 Participants LEVEL 2 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=2 Participants LEVEL 2 followed by LEVEL 3 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only n=9 Participants LEVEL 3 - participants who received - 6x10\^6 Chimeric Antigen Receptor (CAR) T cells only
Number of Participants Who Had a Second or Third Infusion of Chimeric Antigen Receptor (CAR)+ T Cells Second infusion	0 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Who Had a Second or Third Infusion of Chimeric Antigen Receptor (CAR)+ T Cells Third infusion	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 14 days up to 5 years post cell infusion.

Depending on the type of disease, we use PET/CT imaging, tumor biopsies as well as bone marrow biopsies using immunohistochemistry and flow cytometry.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Biological/Vaccine: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells Dose-escalation trial starting dose: 0.66x10\^6 CAR+ T cells/kg (weight-based dosing) (up to a maximum dose of 18x10\^6 CAR+ T cells/kg) infuse on day 0 Drug: Cyclophosphamide 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Drug: Fludarabine 30 mg/m\^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells n=2 Participants LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10\^6 CAR T cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=1 Participants LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only n=4 Participants LEVEL 2 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=2 Participants LEVEL 2 followed by LEVEL 3 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only n=9 Participants LEVEL 3 - participants who received - 6x10\^6 Chimeric Antigen Receptor (CAR) T cells only
Number of Participants Who Had Anti-Lymphoma Activity	3 Participants	2 Participants	1 Participants	2 Participants	1 Participants	6 Participants

SECONDARY outcome

Timeframe: 9 days to 6 weeks after CAR T-cell infusion

Enzyme-linked spot (ELISPOT) assays were performed to look for anti-CAR T-cell responses.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Biological/Vaccine: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells Dose-escalation trial starting dose: 0.66x10\^6 CAR+ T cells/kg (weight-based dosing) (up to a maximum dose of 18x10\^6 CAR+ T cells/kg) infuse on day 0 Drug: Cyclophosphamide 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Drug: Fludarabine 30 mg/m\^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells n=2 Participants LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10\^6 CAR T cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=1 Participants LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only n=4 Participants LEVEL 2 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=2 Participants LEVEL 2 followed by LEVEL 3 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only n=9 Participants LEVEL 3 - participants who received - 6x10\^6 Chimeric Antigen Receptor (CAR) T cells only
Number of Participants With Evidence of Immunogenicity of the Chimeric Antigen Receptor (CAR) T-cell Product	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately 49 months and 19 days.

Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Biological/Vaccine: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells Dose-escalation trial starting dose: 0.66x10\^6 CAR+ T cells/kg (weight-based dosing) (up to a maximum dose of 18x10\^6 CAR+ T cells/kg) infuse on day 0 Drug: Cyclophosphamide 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Drug: Fludarabine 30 mg/m\^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells n=2 Participants LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10\^6 CAR T cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=1 Participants LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only n=4 Participants LEVEL 2 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=2 Participants LEVEL 2 followed by LEVEL 3 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only n=9 Participants LEVEL 3 - participants who received - 6x10\^6 Chimeric Antigen Receptor (CAR) T cells only
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	3 Participants	2 Participants	1 Participants	4 Participants	2 Participants	9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 60 days of Chimeric Antigen Receptor (CAR) T cells infusion

The maximum tolerated dose is the dose at which a maximum of 1 of 6 patients has a dose limiting toxicity (DLT- Grade 3 toxicities possibly or probably related to toxicities possibly or probably related to either the anti-CD19 CAR T cells or the fludarabine and cyclophosphamide chemotherapy and lasting more than 7 days . Grade 4 toxicities possibly or probably related to the study interventions.).

Outcome measures

Outcome measures
Measure	All Participants n=20 Participants All participants who received Biological/Vaccine: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells Dose-escalation trial starting dose: 0.66x10\^6 CAR+ T cells/kg (weight-based dosing) (up to a maximum dose of 18x10\^6 CAR+ T cells/kg) infuse on day 0 Drug: Cyclophosphamide 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Drug: Fludarabine 30 mg/m\^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10\^6 CAR T cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only LEVEL 2 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells LEVEL 2 followed by LEVEL 3 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only LEVEL 3 - participants who received - 6x10\^6 Chimeric Antigen Receptor (CAR) T cells only
MTD	NA T-cells/kg The maximum tolerated dose for this protocol was not reached. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 60 days of Chimeric Antigen Receptor (CAR) T cells infusion

Number of participants with DLT's defined as follows: Grade 3 toxicities possibly or probably related to toxicities possibly or probably related to either the anti-CD19 CAR T cells or the fludarabine and cyclophosphamide chemotherapy and lasting more than 7 days. Grade 4 toxicities possibly or probably related to the study interventions.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Biological/Vaccine: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells Dose-escalation trial starting dose: 0.66x10\^6 CAR+ T cells/kg (weight-based dosing) (up to a maximum dose of 18x10\^6 CAR+ T cells/kg) infuse on day 0 Drug: Cyclophosphamide 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Drug: Fludarabine 30 mg/m\^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells n=2 Participants LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10\^6 CAR T cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=1 Participants LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only n=4 Participants LEVEL 2 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=2 Participants LEVEL 2 followed by LEVEL 3 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only n=9 Participants LEVEL 3 - participants who received - 6x10\^6 Chimeric Antigen Receptor (CAR) T cells only
Number of Participants With a Dose-Limiting Toxicity (DLT)	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 60 days of Chimeric Antigen Receptor (CAR) T cells infusion

Maximum feasible dose is the dose determined when the maximum tolerated dose (MTD) cannot be reached.

Outcome measures

Outcome measures
Measure	All Participants n=20 Participants All participants who received Biological/Vaccine: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells Dose-escalation trial starting dose: 0.66x10\^6 CAR+ T cells/kg (weight-based dosing) (up to a maximum dose of 18x10\^6 CAR+ T cells/kg) infuse on day 0 Drug: Cyclophosphamide 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Drug: Fludarabine 30 mg/m\^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10\^6 CAR T cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only LEVEL 2 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells LEVEL 2 followed by LEVEL 3 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only LEVEL 3 - participants who received - 6x10\^6 Chimeric Antigen Receptor (CAR) T cells only
Maximum Feasible Dose	0.000006 CAR+T cells/kg	—	—	—	—	—

Adverse Events

LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only

Serious events: 8 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only n=3 participants at risk LEVEL 1 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells n=2 participants at risk LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10\^6 CAR T cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=1 participants at risk LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only n=4 participants at risk LEVEL 2 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=2 participants at risk LEVEL 2 followed by LEVEL 3 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only n=9 participants at risk LEVEL 3 - participants who received - 6x10\^6 Chimeric Antigen Receptor (CAR) T cells only
Endocrine disorders Endocrine disorders - Other, specify	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Infections and infestations Infections and infestations - Other, bacteremia b Fragilis	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Investigations Neutrophil count decreased	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Blood and lymphatic system disorders Anemia	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Infections and infestations Appendicitis	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Cardiac disorders Cardiac arrest	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Gastrointestinal disorders Colitis	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
General disorders Fever	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Vascular disorders Hematoma	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Nervous system disorders Encephalopathy	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Vascular disorders Hypotension	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 2/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Gastrointestinal disorders Ileus	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Infections and infestations Lung infection	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Nervous system disorders Syncope	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Nervous system disorders Tremor	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.

Other adverse events

Other adverse events
Measure	LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only n=3 participants at risk LEVEL 1 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells n=2 participants at risk LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10\^6 CAR T cells	LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=1 participants at risk LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only n=4 participants at risk LEVEL 2 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells only	LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells n=2 participants at risk LEVEL 2 followed by LEVEL 3 - participants who received - 2x10\^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10\^6 CAR T cells	LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only n=9 participants at risk LEVEL 3 - participants who received - 6x10\^6 Chimeric Antigen Receptor (CAR) T cells only
Investigations Alkaline phosphatase increased	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
General disorders Localized edema	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Psychiatric disorders Delirium	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Gastrointestinal disorders Enterocolitis	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Gastrointestinal disorders Esophagitis	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Investigations Fibrinogen decreased	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 2/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	22.2% 2/9 • Number of events 7 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Infections and infestations Infections and infestations - Other, Clostridium difficile	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	75.0% 3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Infections and infestations Soft tissue infection	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Renal and urinary disorders Urinary retention	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Investigations INR increased	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Gastrointestinal disorders Colitis	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	— 0/0 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Eye disorders Conjunctivitis	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	— 0/0 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Gastrointestinal disorders Constipation	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	— 0/0 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Ear and labyrinth disorders Ear pain	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	— 0/0 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	— 0/0 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
General disorders Headache	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Gastrointestinal disorders Ileus	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Ear and labyrinth disorders Otitis media	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Infections and infestations Sinusitis	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Nervous system disorders Somnolence	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Infections and infestations Urinary tract infection	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	22.2% 2/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Psychiatric disorders Confusion	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Infections and infestations Conjunctivitis infective	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Investigations Activated partial thromboplastin time prolonged	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Investigations Alanine aminotransferase increased	66.7% 2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 2/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Blood and lymphatic system disorders Anemia	100.0% 3/3 • Number of events 9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 2/2 • Number of events 7 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 6 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	75.0% 3/4 • Number of events 16 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 2/2 • Number of events 7 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 9/9 • Number of events 55 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Investigations Aspartate aminotransferase increased	100.0% 3/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Gastrointestinal disorders Bloating	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Musculoskeletal and connective tissue disorders Bone pain	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
General disorders Chills	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	22.2% 2/9 • Number of events 5 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Respiratory, thoracic and mediastinal disorders Dyspnea	66.7% 2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Cardiac disorders Electrocardiogram QT corrected interval prolonged	66.7% 2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
General disorders Fatigue	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	33.3% 3/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
General disorders Fever	100.0% 3/3 • Number of events 8 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	75.0% 3/4 • Number of events 6 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 9/9 • Number of events 17 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Gastrointestinal disorders Gastroesophageal reflux disease	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Respiratory, thoracic and mediastinal disorders Hiccups	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Vascular disorders Hypertension	33.3% 1/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	33.3% 3/9 • Number of events 10 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Metabolism and nutrition disorders Hypoalbuminemia	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	75.0% 3/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	77.8% 7/9 • Number of events 19 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Metabolism and nutrition disorders Hyponatremia	33.3% 1/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Metabolism and nutrition disorders Hypophosphatemia	66.7% 2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 2/2 • Number of events 7 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	75.0% 3/4 • Number of events 11 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 2/2 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	88.9% 8/9 • Number of events 47 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Vascular disorders Hypotension	100.0% 3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	22.2% 2/9 • Number of events 5 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Respiratory, thoracic and mediastinal disorders Hypoxia	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Infections and infestations Lung infection	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Investigations Lymphocyte count decreased	100.0% 3/3 • Number of events 9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 2/2 • Number of events 17 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 16 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 4/4 • Number of events 14 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 2/2 • Number of events 13 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 9/9 • Number of events 43 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Infections and infestations Mucosal infection	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Respiratory, thoracic and mediastinal disorders Nasal congestion	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	55.6% 5/9 • Number of events 6 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Investigations Neutrophil count decreased	100.0% 3/3 • Number of events 12 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 2/2 • Number of events 10 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 4/4 • Number of events 12 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 2/2 • Number of events 15 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	88.9% 8/9 • Number of events 100 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Cardiac disorders Pericardial effusion	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Respiratory, thoracic and mediastinal disorders Pleural effusion	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Nervous system disorders Presyncope	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Cardiac disorders Sinus tachycardia	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	44.4% 4/9 • Number of events 5 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Cardiac disorders Supraventricular tachycardia	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Vascular disorders Thromboembolic event	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Nervous system disorders Tremor	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Infections and infestations Upper respiratory infection	66.7% 2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	33.3% 3/9 • Number of events 13 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Reproductive system and breast disorders Vaginal dryness	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Investigations White blood cell decreased	100.0% 3/3 • Number of events 26 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 2/2 • Number of events 12 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	75.0% 3/4 • Number of events 15 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 2/2 • Number of events 33 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 9/9 • Number of events 101 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Investigations Blood bilirubin increased	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Respiratory, thoracic and mediastinal disorders Laryngeal edema	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
General disorders Neck edema	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Investigations Platelet count decreased	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 2/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	77.8% 7/9 • Number of events 33 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	44.4% 4/9 • Number of events 9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Mohs surgery	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Infections and infestations Skin infection	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.	22.2% 2/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months and 19 days. 6 participants were enrolled but not treated and one participant was enrolled and cells were collected, then came off study because of ineligibility and re-enrolled much later and did receive cells at that time.

Additional Information

Dr. James N. Kochenderfer

National Cancer Institute

Phone: 240-760-6062

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place