Status:
TERMINATED
Evaluation of Safety and Efficacy of Allo GDA-201 Natural Killer (NK) Cells in Patients With Relapsed/Refractory B Cell NHL
Lead Sponsor:
Gamida Cell ltd
Conditions:
Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 co...
Detailed Description
The study is divided into a phase I dose escalation phase and a phase II expansion phase. Patients with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL)/high g...
Eligibility Criteria
Inclusion
- Patients must have relapsed/refractory FL or HGBCL/DLBCL that has failed conventional therapy defined as follows:
- Received at least 2 prior lines of therapy
- Transplant ineligible patients allowed assuming they meet criterion a.
- 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
- FL transformed to HGBCL: Must have received at least 1 line of therapy after transformation to DLBCL/HGBCL
- Patients must be at least 18 years of age
- Patients must have adequate hematologic, hepatic, renal, cardiac and pulmonary function prior to any study treatment.
Exclusion
- Central Nervous System (CNS) lymphoma
- Time between previous treatment and first dose of study treatment (rituximab):
- Allogeneic hematopoietic stem cell transplantation (HSCT) \< 6 months prior to study treatment
- Autologous HSCT \< 3 months prior to study treatment
- CAR-T \< 2 months prior to study treatment
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05296525
Start Date
July 5 2022
End Date
April 22 2024
Last Update
March 25 2025
Active Locations (6)
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1
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
2
Loyola University, Cardinal Bernardin Cancer Center
Maywood, Illinois, United States, 60153
3
Dana-Farber/Mass General Brigham Cancer Care, Inc.
Boston, Massachusetts, United States, 02215
4
Henry Ford Medical Center
Detroit, Michigan, United States, 48202