Non-Hodgkin Lymphoma, Multiple Myeloma
GDA-201 is an innate natural killer (NK) cell immunotherapy candidate for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. When combined with targeted antibodies, GDA-201 has shown enhanced antibody-dependent cellular toxicity, or ADCC. In April 2022, the U.S. Food and Drug Administration (FDA) cleared our investigational new drug (IND) application and removed the clinical hold for a cryopreserved formulation of GDA-201.
Clinical Trial Information
The study is a multi-center, open label trial evaluating the cryopreserved formulation of GDA-201. It is currently open to enrollment. The Phase 1 portion of the study is designed to evaluate the safety of GDA-201 in patients with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma (HGBCL), marginal zone lymphoma or mantle cell lymphoma. The Phase 2 expansion phase is designed to evaluate the safety and efficacy of GDA-201 in two patient cohorts, FL and DLBCL/HGBCL. The study will include patients who have relapsed or refractory lymphoma after at least two prior treatments. For more information about the study, please visit www.clinicaltrials.gov (NCT03019666).
GDA-201 has been evaluated in a Phase 1 investigator-led study in patients with refractory non-Hodgkin lymphoma (NHL) and multiple myeloma, demonstrating that GDA-201 generally was well tolerated in 35 patients. Of the 19 patients with NHL, 13 complete responses and one partial response were observed (CRR = 68%, ORR = 74%). No dose-limiting toxicities were observed.
Two-year follow up data in the same Phase 1 study demonstrated an overall survival rate of 78% at two years, with a median duration response of 16 months (Bachanova, et al. ASH 2021. Abstract #3854).