Trial · NCT05296525
Evaluation of Safety and Efficacy of Allo GDA-201 Natural Killer (NK) Cells in Patients With Relapsed/Refractory B Cell NHL
NCT05296525, Phase 1, Phase 2, Terminated, Gamida Cell ltd; results first posted 2025-03-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Safety and Efficacy of Allo GDA-201 Natural Killer (NK) Cells in Patients With Relapsed/Refractory B Cell NHL. Trials, record NCT05296525. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05296525
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Safety and Efficacy of Allo GDA-201 Natural Killer (NK) Cells in Patients With Relapsed/Refractory B Cell NHL
- NCT number
- NCT05296525
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Gamida Cell ltd
- Conditions
- Non-Hodgkin Lymphoma
- Interventions
- GDA-201
- First posted
- 2022-03-25
- Last updated
- 2025-03-25
- Results first posted
- 2025-03-25
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs) | Day 28 | 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 cardiac, central nervous system or pulmonary adverse event. Any Grade 3 or above non-hematologic adverse event that does not resolve to Grade 2 or below within 72 hours, except for renal or hepatic adverse events which may take up to 7 days to resolve Treatment emergent ≥Grade 3 autoimmune disorder Grade 3 or above allergic reaction that does not recover to Grade II or below within 24 hours Grade 4 cytopenia lasting beyond Day 42 (the 28-day DLT observation period will be extend |
| Primary | Phase II: Overall Response Rate | up to 1 year | Patients will be assessed after the infusion of GDA-201 for level of response. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs) | Day 28 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Phase II: Overall Response Rate | up to 1 year | Study was early terminated by Sponsor prior to initiation of the phase II |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs) | GDA-201 - Cohort 1 (Phase I) - Dose Level 1 | Patients who experienced dose limiting toxicities (DLTs) | 0 | Participants | |
| Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs) | GDA-201 - Cohort 1 (Phase I) - Dose Level 2 | Patients who experienced dose limiting toxicities (DLTs) | 0 | Participants | |
| Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs) | GDA-201 - Cohort 1 (Phase I) - Dose Level 3 | Patients who experienced dose limiting toxicities (DLTs) | 0 | Participants | |
| Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs) | GDA-201 - Cohort 1 (Phase I) - Dose Level 4 | Patients who experienced dose limiting toxicities (DLTs) | 0 | Participants | |
| Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs) | GDA-201 - Cohort 1 (Phase I) - Dose Level 1 | Patients who did not experience DLT | 3 | Participants | |
| Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs) | GDA-201 - Cohort 1 (Phase I) - Dose Level 2 | Patients who did not experience DLT | 3 | Participants | |
| Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs) | GDA-201 - Cohort 1 (Phase I) - Dose Level 3 | Patients who did not experience DLT | 3 | Participants | |
| Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs) | GDA-201 - Cohort 1 (Phase I) - Dose Level 4 | Patients who did not experience DLT | 2 | Participants | |
| Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs) | GDA-201 - Cohort 1 (Phase I) - Dose Level 1 | Patients not evaluable for DLT | 1 | Participants | |
| Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs) | GDA-201 - Cohort 1 (Phase I) - Dose Level 2 | Patients not evaluable for DLT | 0 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Level 1 (Week 1 to Week 52) | STARTED | Cohort 1 (Phase I) -Dose Level 1 | 4 | |
| Dose Level 1 (Week 1 to Week 52) | STARTED | Cohort 1 (Phase I) - Dose Level 2 | 0 | |
| Dose Level 1 (Week 1 to Week 52) | STARTED | Cohort 1 (Phase I) - Dose Level 3 | 0 | |
| Dose Level 1 (Week 1 to Week 52) | STARTED | Cohort 1 (Phase I) - Dose Level 4 | 0 | |
| Dose Level 1 (Week 1 to Week 52) | COMPLETED | Cohort 1 (Phase I) -Dose Level 1 | 4 | |
| Dose Level 1 (Week 1 to Week 52) | COMPLETED | Cohort 1 (Phase I) - Dose Level 2 | 0 | |
| Dose Level 1 (Week 1 to Week 52) | COMPLETED | Cohort 1 (Phase I) - Dose Level 3 | 0 | |
| Dose Level 1 (Week 1 to Week 52) | COMPLETED | Cohort 1 (Phase I) - Dose Level 4 | 0 | |
| Dose Level 1 (Week 1 to Week 52) | NOT COMPLETED | Cohort 1 (Phase I) -Dose Level 1 | 0 | |
| Dose Level 1 (Week 1 to Week 52) | NOT COMPLETED | Cohort 1 (Phase I) - Dose Level 2 | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events392
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distention | Gastrointestinal disorders | GDA-201 Cohort 1 (Phase I) - Dose Level 1 | 1 | 4 | 1 |
| other | Abdominal distention | Gastrointestinal disorders | GDA-201 Cohort 1 (Phase I) - Dose Level 2 | 0 | 3 | 0 |
| other | Abdominal distention | Gastrointestinal disorders | GDA-201 Cohort 1 (Phase I) - Dose Level 3 | 0 | 3 | 0 |
| other | Abdominal distention | Gastrointestinal disorders | GDA-201 Cohort 1 (Phase I) - Dose Level 4 | 0 | 3 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | GDA-201 Cohort 1 (Phase I) - Dose Level 1 | 0 | 4 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | GDA-201 Cohort 1 (Phase I) - Dose Level 2 | 0 | 3 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | GDA-201 Cohort 1 (Phase I) - Dose Level 3 | 1 | 3 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | GDA-201 Cohort 1 (Phase I) - Dose Level 4 | 1 | 3 | 2 |
| other | Alanine aminotransferase increased | Investigations | GDA-201 Cohort 1 (Phase I) - Dose Level 1 | 1 | 4 | 1 |
| other | Alanine aminotransferase increased | Investigations | GDA-201 Cohort 1 (Phase I) - Dose Level 2 | 0 | 3 | 0 |
1 to 10 of 392Source ClinicalTrials.gov
See all 392 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GDA-201 Cohort 1 (Phase I) - Dose Level 1 | 0 | 4 |
| Total, all-cause mortality | GDA-201 Cohort 1 (Phase I) - Dose Level 2 | 0 | 3 |
| Total, all-cause mortality | GDA-201 Cohort 1 (Phase I) - Dose Level 3 | 0 | 3 |
| Total, all-cause mortality | GDA-201 Cohort 1 (Phase I) - Dose Level 4 | 0 | 3 |
| Total, other adverse events | GDA-201 Cohort 1 (Phase I) - Dose Level 1 | 4 | 4 |
| Total, other adverse events | GDA-201 Cohort 1 (Phase I) - Dose Level 2 | 3 | 3 |
| Total, other adverse events | GDA-201 Cohort 1 (Phase I) - Dose Level 3 | 3 | 3 |
| Total, other adverse events | GDA-201 Cohort 1 (Phase I) - Dose Level 4 | 3 | 3 |
| Total, serious adverse events | GDA-201 Cohort 1 (Phase I) - Dose Level 1 | 2 | 4 |
| Total, serious adverse events | GDA-201 Cohort 1 (Phase I) - Dose Level 2 | 1 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05296525
GET https://conductscience.org/api/trials/v1/NCT05296525/flow?page=2