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NCT05296525 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Safety and Efficacy of Allo GDA-201 Natural Killer (NK) Cells in Patients With Relapsed/Refractory B Cell NHL
A Phase 1 study, sponsored by Gamida Cell.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT05296525: Clinical Trial Phase 1 study, sponsored by Gamida Cell.
NCT05296525 is a Phase 1 study that was terminated before completion, run by Gamida Cell. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05296525, a Phase 1 study, was terminated before completion, sponsored by Gamida Cell.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This is an open-label, non-randomized, interventional, single group assignment study of GDA-201, an allogeneic cryopreserved Natural Killer (NK) cell therapy derived from donor peripheral blood, in combination with rituximab, monoclonal anti-CD20 antibody, for patients with relapsed or refractory B Cell non-Hodgkin lymphoma (NHL).
Primary Outcome
DLTs defined as one of the following within the first 28 days of the first dose of GDA-201 by the NCI-CTCAE v 5.0. acute graft-versus-host disease (aGvHD) will be assessed according to the Consensus Conference on aGvHD grading: Steroid refractory Grade II aGvHD, defined as GvHD that does not respond to at least 1 mg/kg/day or equivalent of prednisone within 7 days of initiating therapy Grade III or IV aGvHD Grade 4 infusion reaction Grade 4 or 5 related adverse event (AE) Grade 3 or above cardi
Interventions
- DRUG GDA-201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2022-07-05 |
| Est. Completion | 2024-04-22 |
| Phase | Phase 1 |
Why NCT05296525 stopped before completion
NCT05296525 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which GDA-201 is the first listed.
NCT05296525 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05296525 about?
NCT05296525 is a clinical study titled "Evaluation of Safety and Efficacy of Allo GDA-201 Natural Killer (NK) Cells in Patients With Relapsed/Refractory B Cell NHL". This is an open-label, non-randomized, interventional, single group assignment study of GDA-201, an allogeneic cryopreserved Natural Killer (NK) cell therapy derived from donor peripheral blood, in combination with rituximab, monoclonal anti-CD20 antibody, for patients with relapsed or refractory B ...
What is the current status of trial NCT05296525?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2022-07-05. Estimated completion is 2024-04-22.
What interventions are being tested in trial NCT05296525?
The interventions under investigation include: GDA-201 (DRUG).
Who is sponsoring clinical trial NCT05296525?
This trial is sponsored by Gamida Cell, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05296525's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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