Three of 6 patients have an ongoing response.
Caribou Biosciences’ CB-010, an allogeneic chimeric antigen receptor (CAR) T cell therapy, has demonstrated efficacy in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) with a 100% complete responses (CR) rate.1
Data from the ANTLER phase 1 trial (NCT04637763) were presented at the European Hematology Association (EHA) 2022 Congress, June 9-12, held both virtually and in Vienna, Austria, byLoretta J. Nastoupil, MD, Director, Lymphoma Outcomes Database, The University of Texas MD Anderson Cancer Center.
“The preliminary safety and efficacy results are promising. All six patients treated with CB-010 at the initial dose level of 40 million CAR-T cells achieved a complete response, and we are now enrolling dose level 2 and look forward to seeing this study mature,” Nastoupil said in a statement.2 “CB-010 was generally well-tolerated and the adverse events observed are consistent with autologous or allogeneic CAR-T cell therapies.”
The trial has enrolled and treated 6 patients with a median age of 65 years (range, 62-68) who had a median number of 3 prior lines of systemic therapy (range, 2-8) and had all relapsed on their last therapy.1 Lymphoma subtypes included diffuse large B-cell lymphoma (n = 2), follicular lymphoma (n = 2), mantle cell lymphoma (n = 1), and primary mediastinal large B-cell lymphoma (n = 1).
Patients received 40x106 CB-010 cells. Cohort 2, which is currently enrolling, will dose patients with 80x106 cells. All 6 patients had CRs; these responses have continued up to 6 months in 2 of 5 patients that reached that follow-up so far. Altogether, 3 patients have a continuing response. The longest follow-up is 12 months in the first patient who has a continuing CR.
All study participants experienced treatment-emergent adverse events (AEs) and 4 participants experienced treatment-related AEs of grade 3 or higher including neutropenia, thrombocytopenia, and white blood cell count decrease. Two patients also developed low grade cytokine release syndrome, 1 developed grade 3 immune effector cell-associated neurotoxicity syndrome, and 2 patients developed grade 2 and 3 infections. No graft-versus-host disease has been observed.
“We believe the 100% complete response achieved in the ANTLER CB-010 trial is unparalleled for a single, starting dose of cell therapy and represents an important step toward showing the potential of our chRDNA genome-editing platform and pipeline of allogeneic cell therapies,” Rachel Haurwitz, PhD, president and chief executive officer, Caribou, added to the statement.2 “As the first allogeneic anti-CD19 CAR-T cell therapy in the clinic with a PD-1 knockout, CB-010 is designed to have sustained antitumor activity by limiting premature CAR-T cell exhaustion in patients with r/r B-NHL. As we enroll patients in cohort 2 at dose level 2 of the ANTLER trial, we are grateful for the patients, caregivers, and investigators who have participated in this clinical trial. We continue to advance CB-010, as our goal is to develop an allogeneic cell therapy that may meaningfully rival autologous cell therapies and extend the potential reach of off-the-shelf treatments for patients.”