Evaluation of Safety and Efficacy of Allo GDA-201 Natural Killer (NK) Cells in Patients With Relapsed/Refractory B Cell NHL

Stopped early · Phase 1/Phase 2

Conditions studied: Non-Hodgkin Lymphoma

In brief

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).

Key facts

Study ID

NCT05296525

Run by

Gamida Cell ltd

People needed

13

Starts

2022-07-05

Expected to finish

2024-04-22

Last updated by the study team

2025-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Loyola University, Cardinal Bernardin Cancer Center — Maywood, Illinois, United States
• Dana-Farber/Mass General Brigham Cancer Care, Inc. — Boston, Massachusetts, United States
• Henry Ford Medical Center — Detroit, Michigan, United States
• Regents of the University of Minnesota — Minneapolis, Minnesota, United States
• Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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