Clinical trial NCT05296525: Evaluation of Safety and Efficacy of Allo GDA-201 Natural Killer (NK) Cells in Patients With Relapsed/Refractory B Cell NHL
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Non-Hodgkin Lymphoma
Keywords: lymphoma
GDA-201
NK cells
rituximab
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lead sponsor: Gamida Cell ltd
Sponsor class: INDUSTRY
First posted: 2022-03-25
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Dose escalation cohort 1 to reach the maximal tolerated dose, followed by cohort 2 using the recommended Phase II Dose
Primary purpose: TREATMENT

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).

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.

Eligibility 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
   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. Central Nervous System (CNS) lymphoma
2. Time between previous treatment and first dose of study treatment (rituximab):

   1. Allogeneic hematopoietic stem cell transplantation (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

Primary outcomes:
measure: Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs)
timeFrame: Day 28
measure: Phase II: Overall Response Rate
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Maywood
country: United States
facility: Loyola University, Cardinal Bernardin Cancer Center
state: Illinois
city: Boston
country: United States
facility: Dana-Farber/Mass General Brigham Cancer Care, Inc.
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Regents of the University of Minnesota
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital
state: New York
Study officials:
References: