Trial Outcomes & Findings for Tregs for the Treatment of Acute Respiratory Distress Syndrome (ARDS) Associated With COVID-19 (regARDS) (NCT NCT05027815)
NCT ID: NCT05027815
Last Updated: 2023-06-05
Results Overview
DLT is defined as any related treatment-emergent adverse event (TEAE) with a National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE 5.0) grade ≥ 3 which also represents a shift from baseline clinical status of ≥ 1 NCI CTCAE grade
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
7 participants
Primary outcome timeframe
28 days post infusion
Results posted on
2023-06-05
Participant Flow
Participants were recruited from participating medical centers with the first participant consented September 23, 2021 and the last participant consented February 10, 2022.
Of 7 participants consented, 4 met eligibility criteria and were assigned to a treatment arm. Three were enrolled in the 100x10\^6 cells arm, and one was enrolled in the 200 x 10\^6 cells arm.
Participant milestones
| Measure |
cePolyTregs 100 x10^6 Cells Open Label
single dose of 100 x 10\^6 cells by IV infusion
Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells: cryopreserved cellular therapy product in cryostor CS5, for IV infusion
|
cePolyTregs 200 x10^6 Cells Open Label
single dose of 200 x 10\^6 cells by IV infusion
Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells: cryopreserved cellular therapy product in cryostor CS5, for IV infusion
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
cePolyTregs 100 x10^6 Cells Open Label
single dose of 100 x 10\^6 cells by IV infusion
Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells: cryopreserved cellular therapy product in cryostor CS5, for IV infusion
|
cePolyTregs 200 x10^6 Cells Open Label
single dose of 200 x 10\^6 cells by IV infusion
Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells: cryopreserved cellular therapy product in cryostor CS5, for IV infusion
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
Baseline Characteristics
Tregs for the Treatment of Acute Respiratory Distress Syndrome (ARDS) Associated With COVID-19 (regARDS)
Baseline characteristics by cohort
| Measure |
cePolyTregs 100 x10^6 Cells Open Label
n=3 Participants
single dose of 100 x 10\^6 cells by IV infusion
Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells: cryopreserved cellular therapy product in cryostor CS5, for IV infusion
|
cePolyTregs 200 x10^6 Cells Open Label
n=1 Participants
single dose of 200 x 10\^6 cells by IV infusion
Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells: cryopreserved cellular therapy product in cryostor CS5, for IV infusion
|
Total
n=4 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
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days post infusionDLT is defined as any related treatment-emergent adverse event (TEAE) with a National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE 5.0) grade ≥ 3 which also represents a shift from baseline clinical status of ≥ 1 NCI CTCAE grade
Outcome measures
| Measure |
cePolyTregs 100 x10^6 Cells Open Label
n=3 Participants
single dose of 100 x 10\^6 cells by IV infusion
Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells: cryopreserved cellular therapy product in cryostor CS5, for IV infusion
|
cePolyTregs 200 x10^6 Cells Open Label
n=1 Participants
single dose of 200 x 10\^6 cells by IV infusion
Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells: cryopreserved cellular therapy product in cryostor CS5, for IV infusion
|
|---|---|---|
|
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
Adverse Events
cePolyTregs 100 x10^6 Cells Open Label
Serious events: 3 serious events
Other events: 2 other events
Deaths: 2 deaths
cePolyTregs 200 x10^6 Cells Open Label
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
cePolyTregs 100 x10^6 Cells Open Label
n=3 participants at risk
single dose of 100 x 10\^6 cells by IV infusion
Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells: cryopreserved cellular therapy product in cryostor CS5, for IV infusion
|
cePolyTregs 200 x10^6 Cells Open Label
n=1 participants at risk
single dose of 200 x 10\^6 cells by IV infusion
Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells: cryopreserved cellular therapy product in cryostor CS5, for IV infusion
|
|---|---|---|
|
Renal and urinary disorders
Renal Failure requiring renal replacement therapy by CRRT
|
33.3%
1/3 • Number of events 1 • up to 84 days post treatment
|
0.00%
0/1 • up to 84 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
33.3%
1/3 • Number of events 1 • up to 84 days post treatment
|
0.00%
0/1 • up to 84 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Refractory Hypoxemia
|
33.3%
1/3 • Number of events 1 • up to 84 days post treatment
|
0.00%
0/1 • up to 84 days post treatment
|
|
Infections and infestations
Ventilator-Associated Pneumonia
|
0.00%
0/3 • up to 84 days post treatment
|
100.0%
1/1 • Number of events 1 • up to 84 days post treatment
|
Other adverse events
| Measure |
cePolyTregs 100 x10^6 Cells Open Label
n=3 participants at risk
single dose of 100 x 10\^6 cells by IV infusion
Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells: cryopreserved cellular therapy product in cryostor CS5, for IV infusion
|
cePolyTregs 200 x10^6 Cells Open Label
n=1 participants at risk
single dose of 200 x 10\^6 cells by IV infusion
Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells: cryopreserved cellular therapy product in cryostor CS5, for IV infusion
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonmediastinum
|
33.3%
1/3 • Number of events 1 • up to 84 days post treatment
|
0.00%
0/1 • up to 84 days post treatment
|
|
Vascular disorders
hypotension
|
33.3%
1/3 • Number of events 1 • up to 84 days post treatment
|
0.00%
0/1 • up to 84 days post treatment
|
|
General disorders
Fever
|
0.00%
0/3 • up to 84 days post treatment
|
100.0%
1/1 • Number of events 1 • up to 84 days post treatment
|
Additional Information
Jonathan Esensten MD, PhD
University of California, San Francisco
Phone: 415-502-3785
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place