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

NCT05296525 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: GC P#01.01.050
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 6

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 combination with rituximab, monoclonal anti-CD20 antibody, for patients with relapsed or refractory B Cell non-Hodgkin lymphoma (NHL).

Conditions

Non-Hodgkin Lymphoma

Keywords

lymphoma; GDA-201; NK cells; rituximab; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse

Outcome Measures

Primary Outcomes (2)

• Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs)

  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

  Day 28

• Phase II: Overall Response Rate

  Patients will be assessed after the infusion of GDA-201 for level of response.

  up to 1 year

Study Arms (2)

GDA-201 Cohort 1 (Phase I)

OTHER

Dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D).

Drug: GDA-201

GDA-201 Cohort 2 (Phase II)

OTHER

RP2D will be administered to all patients.

Drug: GDA-201

Interventions

GDA-201 DRUG

NAM-expanded allogeneic NK cells

Also known as: Nicotinamide (NAM) NK

GDA-201 Cohort 1 (Phase I); GDA-201 Cohort 2 (Phase II)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Gamida Cell ltd: lead

Study Sites (6)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Loyola University, Cardinal Bernardin Cancer Center

Maywood, Illinois, 60153, United States

Location

Dana-Farber/Mass General Brigham Cancer Care, Inc.

Boston, Massachusetts, 02215, United States

Location

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

Regents of the University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Associate director, Clinical Operations
• Organization: Gamida Cell

aurelie@gamida-cell.com

+972556660324

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation cohort 1 to reach the maximal tolerated dose, followed by cohort 2 using the recommended Phase II Dose

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 25, 2022
• Study Start: July 5, 2022
• Primary Completion: April 22, 2024
• Study Completion: April 22, 2024
• Last Updated: March 25, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-03

Locations

US (6)