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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-05

Study Completion Date

2024-04-22

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Non-Hodgkin Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GDA-201 Cohort 1 (Phase I)

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

Group Type OTHER

GDA-201

Intervention Type DRUG

NAM-expanded allogeneic NK cells

GDA-201 Cohort 2 (Phase II)

RP2D will be administered to all patients.

Group Type OTHER

GDA-201

Intervention Type DRUG

NAM-expanded allogeneic NK cells

Interventions

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GDA-201

NAM-expanded allogeneic NK cells

Intervention Type DRUG

Other Intervention Names

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Nicotinamide (NAM) NK

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No