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

Non-Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05296525
• Other study ID #: GC P#01.01.050
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: July 5, 2022
• Est. completion date: April 22, 2024

Study information

• Verified date: May 2024
• Source: Gamida Cell ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 grade B-cell lymphoma (HGBCL) will receive GDA-201 followed by a short course of low-dose interleukin-2 (IL-2). Rituximab will be administered prior to and after GDA-201 infusion.

Phase I: Dose escalation phase The objective of Phase I is to evaluate the safety of GDA-201 in patients with FL, DLBCL/ HGBCL, marginal zone lymphoma or mantle cell lymphoma. The maximal tolerated dose (MTD) and recommended Phase II Dose (RP2D) will be determined based on dose limiting toxicities (DLT).

Phase II expansion phase The objective of the Phase II expansion cohort is to evaluate the safety and efficacy of GDA-201 in two patient cohorts, FL and DLBCL/HGBCL.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: April 22, 2024
• Est. primary completion date: April 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. CNS lymphoma

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

1. Allogeneic 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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

Drug:
• GDA-201
NAM-expanded allogeneic NK cells

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gamida Cell ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: 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. aGvHD will be assessed according to the Consensus Conference on Acute GvHD 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 extended to confirm)	Day 28
Primary	Phase 2: overall response rate	Patients will be assessed after the infusion of GDA-201 for level of response.	up to 1 year