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NK Cell Therapy Trial Doses First Patient With Lymphoma

The FDA recently accepted the company’s BLA for omidubicel for priority review.

Gamida Cell has dosed the first patient in their company-sponsored phase 1/2 trial of the natural killer (NK) cell therapy GDA-201 for the potential treatment of follicular and diffuse large B cell lymphomas.1

“We are excited to further advance the development of GDA-201, a NAM-enabled NK cell therapy candidate which we believe has the potential to be a new readily available, cryopreserved treatment option for cancer patients with relapsed/refractory lymphoma,” Ronit Simantov, MD, chief medical and scientific officer, Gamida Cell, said in a statement.1 “Our NK cells elicited an adaptive immune response in patients in the previous investigator-sponsored study with the fresh formulation of GDA-201, potentially leading to durable remissions. We are truly grateful for the contribution of all the participants and clinical collaborators who will allow us to continue studying GDA-201 in this multi-center open label trial.”

The study is beginning with a phase 1 dose escalation phase that will evaluate the safety of a cryopreserved, readily available formulation of GDA-201 in patients with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma, marginal zone lymphoma or mantle cell lymphoma. The phase 2 expansion phase will evaluate both safety and efficacy of the therapy in 63 participants with either FL or DLBCL. Participants have to have disease relapsed/refractory to at least 2 prior treatments, not excluding prior chimeric antigen receptor (CAR) T-cell therapy or stem cell transplant.

GDA-201 is developed using Gamida Cell’s proprietary nicotinamide (NAM) technology platform. The platform is designed to allow for expanded number and functionality of the NK cells to improve tumor cell killing and antibody-dependent cellular cytotoxicity. The therapy, in combination with standard-of-care antibody therapies, is being investigated in most hematologic malignancies and solid tumors.

READ MORE: 1-Year Data on Omidubicel Shows Sustained Benefits, Reduced Infection Rates

The same formulation of GDA-201 is currently being investigated in an investigator-sponsored phase 1/2 study in relapsed/refractory multiple myeloma (MM) or relapsed/refractory CD20-positive non-Hodgkin lymphomas (NHL). The trial continues to enroll at Henry Ford Cancer Institute (Detroit, MI) and the Masonic Cancer Center at the University of Minnesota. This trial demonstrated GDA-201's potential in lymphoma in combination with rituximab.

Investigators found that out of 19 patients with NHL, 13 had complete responses and 1 had a partial response, for an overall response rate of 74% and a complete response rate of 68%. These participants had a median duration of response of 16 months (range, 5-36) and an overall survival rate of 78% (95% CI, 51-91) at 2 years. GDA-201 was well-tolerated and no dose-limiting toxicities were observed in the 19 patients with NHL as well as the 16 patients with MM. Common serious adverse events included thrombocytopenia, hypertension, neutropenia, febrile neutropenia, and anemia, but there were no cases of cytokine release syndrome, neurotoxic events, graft versus host disease or marrow aplasia.

“Interest in NK cell therapies has increased in recent years as a potential alternative to current cell therapies, as NK cells have the potential to be effective in hematological and solid tumors while avoiding common safety issues,” Veronika Bachanova, MD, PhD, University of Minnesota, added to the statement.1 “We are particularly excited about Gamida’s cryopreserved formulation of GDA-201, which has potential as a new treatment option for patients.”

Gamida Cell is also developing their allogeneic hematopoietic stem cell transplant candidate omidubicel with the NAM technology platform. The FDA accepted a biologics license application (BLA) for priority review for omidubicel in August 2022.2 The BLA was supported by data from the phase 3 clinical trial (NCT02730299), which demonstrated faster hematopoietic recovery and fewer early transplant-related complications with omidubicel treatment compared with standard umbilical cord blood transplantation (UCBT).3

REFERENCES
1. Gamida Cell announces dosing of first patient in company-sponsored phase 1/2 study of NK cell therapy candidate GDA-201. News release. Gamida Cell. August 10, 2022. https://www.businesswire.com/news/home/20220810005248/en/Gamida-Cell-Announces-Dosing-of-First-Patient-in-Company-Sponsored-Phase-12-Study-of-NK-Cell-Therapy-Candidate-GDA-201
2. Gamida Cell announces FDA acceptance of Biologics License Application for omidubicel with priority review. News release. Gamida Cell, Ltd. August 1, 2022. https://www.biospace.com/article/releases/gamida-cell-announces-fda-acceptance-of-biologics-license-application-for-omidubicel-with-priority-review/?keywords=Gamida+Cell
3. Horwitz ME, Stiff PJ, Cutler C, et al. Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study. Blood. 2021;138(16):1429-1440. doi:10.1182/blood.2021011719