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

Phase 1

Terminated

• Conditions: Non-Hodgkin Lymphoma
• Interventions: Drug: GDA-201

• Registration Number: NCT05296525
• Lead Sponsor: Gamida Cell ltd

Brief 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).

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 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.

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-25
• Study Start: 2022-07-05
• Primary Completion: 2024-04-22
• Study Completion: 2024-04-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GDA-201	GDA-201	Phase 1 dose escalation with up to 4 dose levels to reach MTD and determine recommended phase 2 dose (RP2D). Phase 2 RP2D will be administered to all patients.

Primary Outcome Measures

Name	Time	Method
Phase 1: Safety as determined by dose limiting toxicities (DLTs)	Day 28	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)
Phase 2: overall response rate	up to 1 year	Patients will be assessed after the infusion of GDA-201 for level of response.

Trial Locations

Locations (6)

Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital; 🇺🇸 New York, New York, United States

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