Phase I/II Evaluation of Safety and Efficacy of Allo GDA-201 NK Cells in Patients With Relapsed/Refractory B Cell NHL

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, non-randomized, interventional, single group assignment study of GDA-201, an allogeneic cryopreserved 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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gamida Cell ltd

Criteria

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 are eligible

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. CNS lymphoma

2. Time between previous treatment and first dose of study treatment (rituximab):

1. Allogeneic HSCT < 6 months prior to study treatment

2. ASCT < 3 months prior to study treatment

3. CAR-T < 2 months prior to study treatment