Clinical trial · Interventional
Evaluation of Safety and Efficacy of Allo GDA-201 Natural Killer (NK) Cells in Patients With Relapsed/Refractory B Cell NHL
A Phase I/II Multicenter Study Evaluating the Safety and Efficacy of Allogeneic GDA-201 Natural Killer Cells in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated by Sponsor.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GDA-201 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- GDA-201 Cohort 1 (Phase I)
- description
- Dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D).
- interventionNames
- Drug: GDA-201
- type
- OTHER
- label
- GDA-201 Cohort 2 (Phase II)
- description
- RP2D will be administered to all patients.
- interventionNames
- Drug: GDA-201
Primary outcomes (2)
- measure
- Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs)
- timeFrame
- Day 28
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have relapsed/refractory FL or HGBCL/DLBCL that has failed conventional therapy defined as follows: 1. Received at least 2 prior lines of therapy 2. Transplant ineligible patients allowed assuming they meet criterion a. 3. Patients who received prior chimeric antigen receptor modified T-cells (CAR-T) cell therapy or are considered ineligible for CAR-T therapy per the investigator's discretion 4. FL transformed to HGBCL: Must have received at least 1 line of therapy after transformation to DLBCL/HGBCL 2. Patients must be at least 18 years of age 3. Patients must have adequate hematologic, hepatic, renal, cardiac and pulmonary function prior to any study treatment. Exclusion Criteria: 1. Central Nervous System (CNS) lymphoma 2. Time between previous treatment and first dose of study treatment (rituximab): 1. Allogeneic hematopoietic stem cell transplantation (HSCT) \< 6 months prior to study treatment 2. Autologous HSCT \< 3 months prior to study treatment 3. CAR-T \< 2 months prior to study treatment
References
Publications (0)
Data not yet available