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).
Additional locations may be listed on ClinicalTrials.gov for NCT05296525.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Name Not Available
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.
Lead OrganizationGamida Cell