Trial Outcomes & Findings for T-cell Receptor α/β Depleted Donor Lymphocyte Infusion (NCT NCT05350163)

Last Updated: 2024-12-10

Results Overview

TE-SAEs are defined as the composite of death, non-fatal pulmonary embolism, stroke, acute graft versus host disease (GvHD), and clinically significant laboratory test abnormalities.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

11 participants

Primary outcome timeframe

30 days post-infusion

Results posted on

2024-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	HLA Matched Cohort I 5 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Mismatched Cohort I 1 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
Overall Study STARTED	10	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	10	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

T-cell Receptor α/β Depleted Donor Lymphocyte Infusion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HLA Matched Cohort I n=10 Participants 5 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Matched Cohort II 5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Matched Cohort III 5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 2 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Mismatched Cohort I n=1 Participants 1 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Mismatched Cohort II 1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 5 x 10\^5/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Mismatched Cohort III 1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	Total n=11 Participants Total of all reporting groups
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=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	5 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=8 Participants	6 Participants n=8 Participants
Age, Categorical >=65 years	5 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=8 Participants	5 Participants n=8 Participants
Age, Continuous	60.4 years STANDARD_DEVIATION 14.3 • n=5 Participants	—	—	57 years STANDARD_DEVIATION 0 • n=4 Participants	—	—	60.1 years STANDARD_DEVIATION 13.6 • n=8 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	—	—	0 Participants n=4 Participants	—	—	4 Participants n=8 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	—	—	1 Participants n=4 Participants	—	—	7 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	—	—	0 Participants n=4 Participants	—	—	5 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	—	—	1 Participants n=4 Participants	—	—	6 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	—	—	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	—	—	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	—	1 Participants n=4 Participants	—	—	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	—	—	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	—	—	0 Participants n=8 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	—	—	0 Participants n=4 Participants	—	—	10 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	—	—	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	—	—	0 Participants n=8 Participants
Region of Enrollment United States	10 participants n=5 Participants	—	—	1 participants n=4 Participants	—	—	11 participants n=8 Participants

PRIMARY outcome

Timeframe: 30 days post-infusion

Population: The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially.

TE-SAEs are defined as the composite of death, non-fatal pulmonary embolism, stroke, acute graft versus host disease (GvHD), and clinically significant laboratory test abnormalities.

Outcome measures

Outcome measures
Measure	HLA Matched Cohort I n=10 Participants 5 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Matched Cohort II 5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Matched Cohort III 5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 2 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Mismatched Cohort I n=1 Participants 1 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Mismatched Cohort II 1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 5 x 10\^5/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Mismatched Cohort III 1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
Incidence of Treatment-emergent Serious Adverse Events (TE-SAEs)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Because the study was terminated early, no participants completed 2 years.

Remission - measured by absence of signs and symptoms

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Because the study was terminated early, no participants completed 2 years

Transplant-associated viral complications - measured by viral infections associated with transplant

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Because the study was terminated early, no participants completed 2 years.

Disease free survival - measured by (absence of ) relapse/recurrence or death. Relapse and recurrence, both will be measured by greater than 5% circulating leukemic blasts in the marrow or peripheral blood and/or the presence of blasts in any extra medullary site and/or disease determined by clinical assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Because the study was terminated early, no participants completed 2 years.

Overall survival - measured by death

Outcome measures

Outcome data not reported

Adverse Events

HLA Matched Cohort I

Serious events: 6 serious events

Other events: 10 other events

Deaths: 5 deaths

HLA Matched Cohort II

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HLA Matched Cohort III

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HLA Mismatched Cohort I

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

HLA Mismatched Cohort II

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HLA Mismatched Cohort III

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HLA Matched Cohort I n=10 participants at risk 5 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Matched Cohort II 5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Matched Cohort III 5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 2 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Mismatched Cohort I n=1 participants at risk 1 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Mismatched Cohort II 1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 5 x 10\^5/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Mismatched Cohort III 1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
Blood and lymphatic system disorders Febrile neutropenia	20.0% 2/10 • Number of events 2 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	100.0% 1/1 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Infections and infestations Lung infection	20.0% 2/10 • Number of events 2 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Infections and infestations Upper respiratory infection	10.0% 1/10 • Number of events 2 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Cardiac disorders Chest pain	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Nervous system disorders Cognitive disturbance	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Gastrointestinal disorders Colitis	0.00% 0/10 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	100.0% 1/1 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Investigations Decreased platelet count	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Skin and subcutaneous tissue disorders Rash maculo-papular	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Respiratory, thoracic and mediastinal disorders Respiratory failure	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.

Other adverse events

Other adverse events
Measure	HLA Matched Cohort I n=10 participants at risk 5 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Matched Cohort II 5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Matched Cohort III 5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 2 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Mismatched Cohort I n=1 participants at risk 1 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Mismatched Cohort II 1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 5 x 10\^5/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	HLA Mismatched Cohort III 1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
Gastrointestinal disorders Diarrhea	50.0% 5/10 • Number of events 7 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Infections and infestations Epstein-Barr virus infection reactivation	30.0% 3/10 • Number of events 3 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	100.0% 1/1 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
General disorders Fatigue	20.0% 2/10 • Number of events 2 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Blood and lymphatic system disorders Febrile neutropenia	20.0% 2/10 • Number of events 2 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Infections and infestations Viremia	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	100.0% 1/1 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • Number of events 3 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Infections and infestations Appendicitis	0.00% 0/10 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	100.0% 1/1 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Musculoskeletal and connective tissue disorders Back pain	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Infections and infestations Bacteremia	0.00% 0/10 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	100.0% 1/1 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Blood and lymphatic system disorders Other, Large B cell lymphoma	0.00% 0/10 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Infections and infestations Conjunctivitis	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Investigations Decreased platelet count	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Eye disorders Dry eye	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Skin and subcutaneous tissue disorders Eczema	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
General disorders Edema limbs	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
General disorders Generalized edema	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Investigations Elevated ALT	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Investigations Elevated AST	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Infections and infestations Encephalitis infection	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Infections and infestations Folliculitis	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Nervous system disorders Headache	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Hepatobiliary disorders Other, Hepatotoxicity	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Investigations Hypercalcemia	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Vascular disorders Hypotension	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Infections and infestations Other, COVID-19	10.0% 1/10 • Number of events 2 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Infections and infestations Other, Sapovirus	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Infections and infestations Other, Strongloidiasis	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Psychiatric disorders Insomnia	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Gastrointestinal disorders Mucositis oral	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Musculoskeletal and connective tissue disorders Muscle cramp	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Gastrointestinal disorders Nausea	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Gastrointestinal disorders Oral pain	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Skin and subcutaneous tissue disorders Rash	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Respiratory, thoracic and mediastinal disorders Respiratory failure	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Infections and infestations Sepsis	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Vascular disorders Hematoma	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Nervous system disorders Syncope	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Renal and urinary disorders Urinary tract pain	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
Infections and infestations Vaginal infection	10.0% 1/10 • Number of events 1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	0.00% 0/1 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.	— 0/0 • The longest any participant was on study was approximately 14 months. The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.

Additional Information

Director, Research Concept & Protocol Development

Miami Cancer Institute at Baptist Health, Inc.

Phone: (786) 527-9546

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place