The full data readout from the phase 1/2 clinical trial is expected in the first quarter of 2024.
GDA-201 natural killer cell therapy has shown early evidence of antitumor activity in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL).1
Gamida Cell announced the preliminary data from 10 patients with CD20 positive NHL enrolled in a phase 1/2 trial (NCT05296525) evaluating the allogeneic therapy for safety and tolerability in combination with rituximab after fludarabine/cyclophosphamide lymphodepletion. GDA-201 is comprised of NK cells developed with Gamida Cell’s proprietary nicotinamide (NAM) technology designed to enhance NK cells.
The study consists of phase 1 dose-escalation and phase 2 dose-expansions parts and is enrolling patients with follicular (n = 1), diffuse/high-grade (n = 6), marginal zone (n = 2), and mantle zone B-cell lymphomas (n = 1). The company expects the full data readout in the first quarter of 2024.
“We have demonstrated that our nicotinamide (NAM)-modified NK cells have enhanced metabolic fitness, resistance to oxidative stress and potent cytotoxicity, meaning that GDA-201 has the potential for powerful anti-tumor activity," Ronit Simantov, MD, chief medical and scientific officer, Gamida Cell, said in a statement.1 “We are encouraged by the safety and activity observed thus far in our Phase 1 study of cryopreserved GDA-201, which is consistent with results from the Phase 1 study of a fresh formulation of GDA-201 conducted at the University of Minnesota. We look forward to continuing to follow these patients and completing enrollment in our next cohort, and anticipate sharing the full Phase I data in early 2024.”
Enrolled patients had a median of 6 prior lines of therapy, with 6 patients having received CAR T-cell therapy and 4 having received hematopoietic stem cell transplant. The preliminary data show that 5 patients had marked shrinkage of target lesions, 2 patients had a complete response (CR), 2 had a partial response, and 1 had stable disease. The responses look to be dose-dependent, with 2 of 3 patients in cohort 3 responding. The fourth and final cohort, with a target dose of 2x108 cells/kg, is currently enrolling.
GD-201 seems to be well-tolerated, with no dose-limiting toxicities reported with doses up to 1x108 cells/kg. There was 1 case of grade 1 and 1 case of grade 2 cytokine release syndrome, the most common serious adverse event was transient neutropenia, and there were no cases of immune effector cell associated neurotoxicity syndrome or graft versus host disease. One patient died from progressive disease.
The preliminary data from the study further support data on GDA-201 released in July 2023 from a phase 1 trial (NCT03019666) of the fresh formulation conducted at the University of Minnesota. In 19 patients with NHL, there was an overall response rate of 74% and a CR rate of 68%.2 The median duration of response was 16 months (range, 5-36) and GDA-201 cells were detected up to 14 days in patients’ blood.