Trial Outcomes & Findings for Study of CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell (NCT NCT03019055)
NCT ID: NCT03019055
Last Updated: 2023-07-27
Results Overview
This measure is the number of adverse events with grade 3 to 5 severity per Common Terminology Criteria for Adverse Events (ver. 4.03) occurring within the first 28 days following infusion.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
28 days after infusion
Results posted on
2023-07-27
Participant Flow
Of 31 enrolled subjects who signed the informed consent form, 26 met all eligibility criteria.
Participant milestones
| Measure |
CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg)
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (1.0 x10\^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 0: 2.5 x10\^5 CAR-20/19-T cells/kg (starting dose level)
|
CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg)
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (2.5 x10\^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 1: 7.5 x10\^5 CAR-20/19-T cells/kg
|
CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg)
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (7.5 x10\^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 2: 2.5 x10\^6 CAR-20/19-T cells/kg (goal cell dose)
Phase 1b Expansion Dose Level: 2.5 x 10\^6 cells/kg (single infusion)
|
CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg)
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (2.5 x10\^6 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
3
|
3
|
20
|
|
Overall Study
COMPLETED
|
0
|
3
|
3
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell
Baseline characteristics by cohort
| Measure |
CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg)
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (1.0 x10\^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 0: 2.5 x10\^5 CAR-20/19-T cells/kg (starting dose level)
|
CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg)
n=3 Participants
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (2.5 x10\^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 1: 7.5 x10\^5 CAR-20/19-T cells/kg
|
CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg)
n=3 Participants
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (7.5 x10\^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 2: 2.5 x10\^6 CAR-20/19-T cells/kg (goal cell dose)
Phase 1b Expansion Dose Level: 2.5 x 10\^6 cells/kg (single infusion)
|
CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg)
n=20 Participants
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (2.5 x10\^6 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
—
|
52.33 years
STANDARD_DEVIATION 2.31 • n=4 Participants
|
55.00 years
STANDARD_DEVIATION 8.19 • n=27 Participants
|
55.85 years
STANDARD_DEVIATION 14.44 • n=483 Participants
|
55.35 years
STANDARD_DEVIATION 12.87 • n=36 Participants
|
|
Sex: Female, Male
Female
|
—
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
—
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
—
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
—
|
3 participants
n=4 Participants
|
3 participants
n=27 Participants
|
20 participants
n=483 Participants
|
26 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 28 days after infusionPopulation: Of the eligible subjects, CAR cell product did not reach the required cell concentration for infusion for 4 subjects in the highest dosage level. These subjects were withdrawn by the investigator. Overall, 22 subjects received the investigational product in this study. The initial concentration for the study was 2.5x10\^5 cells/kg. No dose limiting toxicities were experienced at this concentration and the reduced dose of 1.0x10\^5 cells/kg was not used.
This measure is the number of adverse events with grade 3 to 5 severity per Common Terminology Criteria for Adverse Events (ver. 4.03) occurring within the first 28 days following infusion.
Outcome measures
| Measure |
CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg)
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (1.0 x10\^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 0: 2.5 x10\^5 CAR-20/19-T cells/kg (starting dose level)
|
CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg)
n=3 Participants
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (2.5 x10\^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 1: 7.5 x10\^5 CAR-20/19-T cells/kg
|
CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg)
n=3 Participants
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (7.5 x10\^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 2: 2.5 x10\^6 CAR-20/19-T cells/kg (goal cell dose)
Phase 1b Expansion Dose Level: 2.5 x 10\^6 cells/kg (single infusion)
|
CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg)
n=16 Participants
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (2.5 x10\^6 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
|
|---|---|---|---|---|
|
Number of Adverse Events After CAR 20/19-T Cell Infusion
|
—
|
7 Serious Adverse Events
|
4 Serious Adverse Events
|
22 Serious Adverse Events
|
Adverse Events
CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg)
Serious events: 16 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg)
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (1.0 x10\^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 0: 2.5 x10\^5 CAR-20/19-T cells/kg (starting dose level)
|
CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg)
n=3 participants at risk
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (2.5 x10\^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 1: 7.5 x10\^5 CAR-20/19-T cells/kg
|
CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg)
n=3 participants at risk
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (7.5 x10\^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 2: 2.5 x10\^6 CAR-20/19-T cells/kg (goal cell dose)
Phase 1b Expansion Dose Level: 2.5 x 10\^6 cells/kg (single infusion)
|
CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg)
n=16 participants at risk
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (2.5 x10\^6 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
General disorders
Fever
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
General disorders
Multi-organ failure
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Immune system disorders
Cytokine release syndrome
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
100.0%
3/3 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Infections and infestations
Upper respiratory infection
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/16 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Investigations
Lymphocyte count increased
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Anorexia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Dehydration
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
18.8%
3/16 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/16 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Renal and urinary disorders
Hematuria
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/16 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/16 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
Other adverse events
| Measure |
CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg)
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (1.0 x10\^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 0: 2.5 x10\^5 CAR-20/19-T cells/kg (starting dose level)
|
CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg)
n=3 participants at risk
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (2.5 x10\^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 1: 7.5 x10\^5 CAR-20/19-T cells/kg
|
CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg)
n=3 participants at risk
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (7.5 x10\^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Phase 1 Dose Level 2: 2.5 x10\^6 CAR-20/19-T cells/kg (goal cell dose)
Phase 1b Expansion Dose Level: 2.5 x 10\^6 cells/kg (single infusion)
|
CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg)
n=16 participants at risk
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
CAR-20/19-T cells (2.5 x10\^6 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Vascular access complication
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
18.8%
3/16 • Number of events 4 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
37.5%
6/16 • Number of events 7 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Infections and infestations
Urinary tract infection
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
18.8%
3/16 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Infections and infestations
Enterocolitis infectious
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Infections and infestations
Lung infection
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
18.8%
3/16 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Injury, poisoning and procedural complications
Fracture
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Investigations
Alanine aminotransferase increased
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
66.7%
2/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
43.8%
7/16 • Number of events 10 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Investigations
Alkaline phosphatase increased
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
37.5%
6/16 • Number of events 10 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Investigations
Aspartate aminotransferase increased
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
56.2%
9/16 • Number of events 17 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Investigations
Blood bilirubin increased
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
18.8%
3/16 • Number of events 6 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Investigations
Creatinine increased
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
66.7%
2/3 • Number of events 7 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
50.0%
8/16 • Number of events 14 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Investigations
Fibrinogen decreased
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Investigations
Lymphocyte count decreased
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
66.7%
2/3 • Number of events 8 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
100.0%
3/3 • Number of events 15 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
100.0%
16/16 • Number of events 49 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Investigations
Lymphocyte count increased
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 4 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Investigations
Neutrophil count decreased
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
100.0%
3/3 • Number of events 12 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
100.0%
3/3 • Number of events 21 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
100.0%
16/16 • Number of events 59 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Investigations
Platelet count decreased
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
66.7%
2/3 • Number of events 12 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
66.7%
2/3 • Number of events 11 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
81.2%
13/16 • Number of events 32 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Blood and lymphatic system disorders
Anemia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
100.0%
3/3 • Number of events 13 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
66.7%
2/3 • Number of events 12 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
87.5%
14/16 • Number of events 37 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Cardiac disorders
Atrial fibrillation
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Cardiac disorders
Sinus bradycardia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
18.8%
3/16 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Cardiac disorders
Sinus tachycardia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
66.7%
2/3 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
62.5%
10/16 • Number of events 15 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Ear and labyrinth disorders
Ear pain
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Ear and labyrinth disorders
Tinnitus
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Eye disorders
Blurred vision
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Eye disorders
Dry eye
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Eye disorders
Eye pain
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Eye disorders
Floaters
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Eye disorders
Watering eyes
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Gastrointestinal disorders
Abdominal distension
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Gastrointestinal disorders
Abdominal pain
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Gastrointestinal disorders
Bloating
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 8 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
37.5%
6/16 • Number of events 9 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
66.7%
2/3 • Number of events 4 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
68.8%
11/16 • Number of events 18 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Gastrointestinal disorders
Dyspepsia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/16 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Gastrointestinal disorders
Dysphagia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Gastrointestinal disorders
Fecal incontinence
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Gastrointestinal disorders
Gingival pain
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/16 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 6 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
68.8%
11/16 • Number of events 17 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Gastrointestinal disorders
Stomach pain
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
18.8%
3/16 • Number of events 5 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Gastrointestinal disorders
Toothache
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/16 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 4 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
18.8%
3/16 • Number of events 4 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
General disorders
Chills
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
General disorders
Facial pain
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
General disorders
Fatigue
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
66.7%
2/3 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
100.0%
3/3 • Number of events 7 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
75.0%
12/16 • Number of events 20 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
General disorders
Fever
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
25.0%
4/16 • Number of events 6 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
General disorders
Flu like symptoms
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
General disorders
Malaise
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
General disorders
Multi-organ failure
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/16 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
General disorders
Pain
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
General disorders
Edema limbs
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
25.0%
4/16 • Number of events 4 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
General disorders
Infusion related reaction
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
General disorders
Non-cardiac chest pain
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
General disorders
Infusion site extravasation
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Immune system disorders
Cytokine release syndrome
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 4 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
81.2%
13/16 • Number of events 18 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
18.8%
3/16 • Number of events 4 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Infections and infestations
Sepsis
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Infections and infestations
Upper respiratory infection
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Investigations
Weight loss
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Investigations
White blood cell decreased
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
100.0%
3/3 • Number of events 9 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
100.0%
3/3 • Number of events 13 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
100.0%
16/16 • Number of events 68 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Anorexia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
25.0%
4/16 • Number of events 5 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
66.7%
2/3 • Number of events 8 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 6 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
56.2%
9/16 • Number of events 14 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
18.8%
3/16 • Number of events 7 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
100.0%
3/3 • Number of events 11 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
62.5%
10/16 • Number of events 27 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
66.7%
2/3 • Number of events 6 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 6 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
81.2%
13/16 • Number of events 27 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
66.7%
2/3 • Number of events 5 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
43.8%
7/16 • Number of events 16 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 7 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 8 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
56.2%
9/16 • Number of events 21 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 4 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
25.0%
4/16 • Number of events 6 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/16 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
18.8%
3/16 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Nervous system disorders
Dizziness
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
37.5%
6/16 • Number of events 10 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Nervous system disorders
Dysphasia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Nervous system disorders
Headache
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
66.7%
2/3 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
50.0%
8/16 • Number of events 11 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Nervous system disorders
Lethargy
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Nervous system disorders
Movements involuntary
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Nervous system disorders
Paresthesia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/16 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/16 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Nervous system disorders
Presyncope
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Nervous system disorders
Somnolence
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Nervous system disorders
Syncope
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Nervous system disorders
Tremor
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Nervous system disorders
Vasovagal reaction
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Nervous system disorders
Facial muscle weakness
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Psychiatric disorders
Agitation
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Psychiatric disorders
Anxiety
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Psychiatric disorders
Confusion
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
18.8%
3/16 • Number of events 4 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Psychiatric disorders
Delirium
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
18.8%
3/16 • Number of events 4 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Psychiatric disorders
Hallucinations
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Psychiatric disorders
Insomnia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/16 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
25.0%
4/16 • Number of events 5 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Renal and urinary disorders
Hematuria
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
18.8%
3/16 • Number of events 4 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Renal and urinary disorders
Proteinuria
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Renal and urinary disorders
Urinary frequency
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Renal and urinary disorders
Urinary incontinence
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
18.8%
3/16 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Renal and urinary disorders
Urinary retention
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Renal and urinary disorders
Urinary tract pain
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Renal and urinary disorders
Acute kidney injury
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
18.8%
3/16 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Reproductive system and breast disorders
Genital edema
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
31.2%
5/16 • Number of events 7 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
66.7%
2/3 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
25.0%
4/16 • Number of events 6 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/16 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/16 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
25.0%
4/16 • Number of events 5 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
12.5%
2/16 • Number of events 2 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
33.3%
1/3 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/16 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Vascular disorders
Hypertension
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
66.7%
2/3 • Number of events 8 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
100.0%
3/3 • Number of events 9 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
50.0%
8/16 • Number of events 13 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Vascular disorders
Hypotension
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
66.7%
2/3 • Number of events 3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
43.8%
7/16 • Number of events 15 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
|
Vascular disorders
Thromboembolic event
|
—
0/0 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
0.00%
0/3 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
6.2%
1/16 • Number of events 1 • 28 days
No subjects were enrolled in the 1.0x10\^5 cells/kg dosage group.
|
Additional Information
Dr. Nirav Shah, MD
Froedtert Hospital and the Medical College of Wisconsin
Phone: 414-805-8900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place