Non Hodgkin Lymphoma Clinical Trial

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

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).

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

CNS lymphoma

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

Allogeneic HSCT < 6 months prior to study treatment
Autologous HSCT < 3 months prior to study treatment
CAR-T < 2 months prior to study treatment

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

99

Study ID:

NCT05296525

Recruitment Status:

Recruiting

Sponsor:

Gamida Cell ltd

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 5 Locations for this study

See Locations Near You

Loyola University, Cardinal Bernardin Cancer Center
Maywood Illinois, 60153, United States More Info
Scott Smith, MD
Contact
708-327-3142
Scott Smith, MD
Principal Investigator
Dana-Farber/Mass General Brigham Cancer Care, Inc.
Boston Massachusetts, 02215, United States More Info
Matthew Frigault, MD
Contact
617-726-5130
Matthew Frigault, MD
Principal Investigator
Henry Ford Medical Center
Detroit Michigan, 48202, United States More Info
Edward Peres, MD
Contact
888-734-5322
Edward Peres, MD
Principal Investigator
Regents of the University of Minnesota
Minneapolis Minnesota, 55455, United States More Info
Veronika Bachanova, MD
Contact
612-625-8287
Veronika Bachanova, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital
New York New York, 10065, United States More Info
Brian Shaffer, MD
Contact
877-836-2268
Brian Shaffer, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

99

Study ID:

NCT05296525

Recruitment Status:

Recruiting

Sponsor:


Gamida Cell ltd

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.