Trial Outcomes & Findings for Safety and Efficacy Study of Sotatercept in Adults With Transfusion Dependent Diamond Blackfan Anemia (NCT NCT01464164)

Last Updated: 2023-03-17

Results Overview

Complete response is transfusion independence with hemoglobin \>9 gm/dl; partial response is transfusion dependence with hemoglobin \< 9gm/dl with an increase in reticulocyte count over baseline

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

19 participants

Primary outcome timeframe

9 months

Results posted on

2023-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	Sotatercept Cohort 1 Cohort 1: Sotatercept 0.1 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept Cohort 2 Cohort 2: Sotatercept 0.3 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept Cohort 3 Cohort 3: Sotatercept 0.5 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept With Prednisone Boost Cohort 4a Cohort 4a: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks with a three week prednisone boost of 1 mg/kg/day (max 60 mg) - to be completed in 3 patients without untoward events	Sotatercept Cohort 4b Cohort 4b: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events	Sotatercept Cohort 5b Cohort 5b: Sotatercept 1 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events
Overall Study STARTED	3	4	4	2	3	3
Overall Study COMPLETED	3	2	2	2	3	1
Overall Study NOT COMPLETED	0	2	2	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Sotatercept Cohort 1 Cohort 1: Sotatercept 0.1 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept Cohort 2 Cohort 2: Sotatercept 0.3 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept Cohort 3 Cohort 3: Sotatercept 0.5 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept With Prednisone Boost Cohort 4a Cohort 4a: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks with a three week prednisone boost of 1 mg/kg/day (max 60 mg) - to be completed in 3 patients without untoward events	Sotatercept Cohort 4b Cohort 4b: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events	Sotatercept With Prednisone Boost Cohort 5a Cohort 5a: Sotatercept 1 mg/kg as a subcutaneous injection every 3 weeks with a 3 week prednisone boost of 1 mg/kg/day (max 60 mg) to be completed in 3 patients without untoward events	Sotatercept Cohort 5b Cohort 5b: Sotatercept 1 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events
Overall Study Screen failure	0	1	2	0	0	0	0
Overall Study Physician Decision	0	1	0	0	0	0	2

Baseline Characteristics

Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sotatercept Cohort 1 n=3 Participants Cohort 1: Sotatercept 0.1 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept Cohort 2 n=4 Participants Cohort 2: Sotatercept 0.3 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept Cohort 3 n=4 Participants Cohort 3: Sotatercept 0.5 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept With Prednisone Boost Cohort 4a n=2 Participants Cohort 4a: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks with a three week prednisone boost of 1 mg/kg/day (max 60 mg) - to be completed in 3 patients without untoward events	Sotatercept Cohort 4b n=3 Participants Cohort 4b: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events	Sotatercept With Prednisone Boost Cohort 5a Cohort 5a: Sotatercept 1 mg/kg as a subcutaneous injection every 3 weeks with a 3 week prednisone boost of 1 mg/kg/day (max 60 mg) to be completed in 3 patients without untoward events	Sotatercept Cohort 5b n=3 Participants Cohort 5b: Sotatercept 1 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events	Total n=19 Participants Total of all reporting groups
Age, Continuous	36 years n=3 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	34 years n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	32 years n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	39 years n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	31 years n=3 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	—	37 years n=1 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	35 years n=13 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.
Sex: Female, Male Female	0 Participants n=3 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	2 Participants n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	1 Participants n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	1 Participants n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	1 Participants n=3 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	0 Participants Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	0 Participants n=1 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	5 Participants n=13 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.
Sex: Female, Male Male	3 Participants n=3 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	0 Participants n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	1 Participants n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	1 Participants n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	2 Participants n=3 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	0 Participants Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	1 Participants n=1 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	8 Participants n=13 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=3 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	0 Participants n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	0 Participants n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	0 Participants n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	1 Participants n=3 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	0 Participants Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	1 Participants n=1 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	3 Participants n=13 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=3 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	2 Participants n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	2 Participants n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	2 Participants n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	2 Participants n=3 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	0 Participants Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	0 Participants n=1 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	10 Participants n=13 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	0 Participants n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	0 Participants n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	0 Participants n=2 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	0 Participants n=3 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	0 Participants Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	0 Participants n=1 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.	0 Participants n=13 Participants • Three subjects of the original consented subjects did not meet the eligibility criteria and were screen failures. Three subjects met the criteria for enrollment but did not complete the study to be analyzed as the subjects were terminated early.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=3 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants	0 Participants	0 Participants n=3 Participants	1 Participants n=19 Participants
Race (NIH/OMB) Asian	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=2 Participants	1 Participants n=3 Participants	0 Participants	0 Participants n=3 Participants	1 Participants n=19 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants	0 Participants	0 Participants n=3 Participants	0 Participants n=19 Participants
Race (NIH/OMB) Black or African American	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants	0 Participants	0 Participants n=3 Participants	0 Participants n=19 Participants
Race (NIH/OMB) White	3 Participants n=3 Participants	2 Participants n=4 Participants	1 Participants n=4 Participants	2 Participants n=2 Participants	2 Participants n=3 Participants	0 Participants	3 Participants n=3 Participants	13 Participants n=19 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants	1 Participants n=4 Participants	3 Participants n=4 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants	0 Participants	0 Participants n=3 Participants	4 Participants n=19 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants	0 Participants	0 Participants n=3 Participants	0 Participants n=19 Participants

PRIMARY outcome

Timeframe: 9 months

Population: Only subjects who completed the trial are analyzed.

Complete response is transfusion independence with hemoglobin \>9 gm/dl; partial response is transfusion dependence with hemoglobin \< 9gm/dl with an increase in reticulocyte count over baseline

Outcome measures

Outcome measures
Measure	Sotatercept Cohort 1 n=3 Participants Cohort 1: Sotatercept 0.1 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept Cohort 2 n=2 Participants Cohort 2: Sotatercept 0.3 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept Cohort 3 n=2 Participants Cohort 3: Sotatercept 0.5 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept With Prednisone Boost Cohort 4a n=2 Participants Cohort 4a: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks with a three week prednisone boost of 1 mg/kg/day (max 60 mg) - to be completed in 3 patients without untoward events	Sotatercept Cohort 4b n=3 Participants Cohort 4b: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events	Sotatercept With Prednisone Boost Cohort 5a Cohort 5a: Sotatercept 1 mg/kg as a subcutaneous injection every 3 weeks with a 3 week prednisone boost of 1 mg/kg/day (max 60 mg) to be completed in 3 patients without untoward events	Sotatercept Cohort 5b n=1 Participants Cohort 5b: Sotatercept 1 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events
Number of Participants With Complete Response and Partial Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 9 months

Population: Only subjects who completed the trial are analyzed.

Assess severity of adverse events and relationship to sotatercept according to the currently active minor version of the NCI Common Terminology for Adverse Events version 4.0

Outcome measures

Outcome measures
Measure	Sotatercept Cohort 1 n=3 Participants Cohort 1: Sotatercept 0.1 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept Cohort 2 n=2 Participants Cohort 2: Sotatercept 0.3 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept Cohort 3 n=2 Participants Cohort 3: Sotatercept 0.5 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept With Prednisone Boost Cohort 4a n=2 Participants Cohort 4a: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks with a three week prednisone boost of 1 mg/kg/day (max 60 mg) - to be completed in 3 patients without untoward events	Sotatercept Cohort 4b n=3 Participants Cohort 4b: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events	Sotatercept With Prednisone Boost Cohort 5a Cohort 5a: Sotatercept 1 mg/kg as a subcutaneous injection every 3 weeks with a 3 week prednisone boost of 1 mg/kg/day (max 60 mg) to be completed in 3 patients without untoward events	Sotatercept Cohort 5b n=1 Participants Cohort 5b: Sotatercept 1 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events
Severe Adverse Events Attributable to Study Drug	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sotatercept Cohort 1 n=3 participants at risk Cohort 1: Sotatercept 0.1 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept Cohort 2 n=2 participants at risk Cohort 2: Sotatercept 0.3 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept Cohort 3 n=2 participants at risk Cohort 3: Sotatercept 0.5 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events	Sotatercept With Prednisone Boost Cohort 4a n=2 participants at risk Cohort 4a: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks with a three week prednisone boost of 1 mg/kg/day (max 60 mg) - to be completed in 3 patients without untoward events	Sotatercept Cohort 4b n=3 participants at risk Cohort 4b: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events	Sotatercept With Prednisone Boost Cohort 5a Cohort 5a: Sotatercept 1 mg/kg as a subcutaneous injection every 3 weeks with a 3 week prednisone boost of 1 mg/kg/day (max 60 mg) to be completed in 3 patients without untoward events	Sotatercept Cohort 5b n=1 participants at risk Cohort 5b: Sotatercept 1 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events
Infections and infestations Hospitalization	0.00% 0/3 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	50.0% 1/2 • Number of events 1 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	0.00% 0/2 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	0.00% 0/2 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	0.00% 0/3 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	— 0/0 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	0.00% 0/1 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.
Endocrine disorders Hospitalization	0.00% 0/3 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	50.0% 1/2 • Number of events 1 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	0.00% 0/2 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	0.00% 0/2 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	0.00% 0/3 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	— 0/0 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	0.00% 0/1 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.
Infections and infestations Elevated liver function tests	0.00% 0/3 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	0.00% 0/2 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	0.00% 0/2 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	0.00% 0/2 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	33.3% 1/3 • Number of events 1 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	— 0/0 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.	0.00% 0/1 • Adverse events were collected for the time the subject was on study, a total of 9 months. Cohort 5a had no subjects enrolled.

Other adverse events

Adverse event data not reported

Additional Information

Adrianna Vlachos, MD

Feinstein Institutes for Medical Research

Phone: 516-562-1506

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place