Caribou Biosciences has reported data from the ongoing ANTLER Phase I trial of allogeneic anti-CD19 CAR-T cell therapy, CB-010, in relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) patients.
The ongoing, open-label, multicentre Phase I clinical trial was designed to evaluate the efficacy and safety of CB-010, the company’s lead allogeneic cell therapy, in r/r B-NHL patients.
It includes two parts; Part A is a three plus three dose escalation phase that will assess CB-010’s safety at multiple dose levels and establish the recommended dose for Phase II.
Part B is a dose expansion phase and will determine the tumour response following a single CB-010 dose as its primary objective.
The new 12-month clinical data from the trial’s first cohort demonstrated long-term durability after a single infusion of CB-010 at the initial dose level one (40×106 CAR-T cells).
Findings showed that all the participants in the cohort achieved a complete response (CR) as best response, three out of six participants maintained a durable CR at six months, and two of them maintained a long-term CR at the 12-month scan.
The US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations to CB-010, based on the initial data.
Caribou president and CEO Rachel Haurwitz said: “With next-generation CRISPR genome-editing technology, the promise of allogeneic cell therapies has advanced significantly, and the early results seen in the ANTLER trial to date are a reflection of that potential.
“The long-term durability at dose level one is comparable to autologous cell therapies and we believe CB-010 has the potential to set a new therapeutic bar for what allogeneic anti-CD19 CAR-T cell therapies can achieve.
“We are further encouraged by receiving RMAT and Fast Track designations for CB-010 from the FDA, which is a testament to both the encouraging initial ANTLER data and the need for novel therapies for patients with relapsed or refractory B-NHL.”
The company is currently enrolling participants at dose level three.
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