According to the data set of all 16 patients treated in this phase, CB-010 was generally well tolerated and the rate of adverse events was similar to autologous or allogeneic anti-CD19 CAR-T cell therapies
Caribou’s CB-010 shows positive results in the dose escalation phase of the Phase 1 trial. (Credit: valelopardo from Pixabay)
Caribou Biosciences announced that its CB-010 therapy has shown a positive response in the dose escalation portion of the ongoing ANTLER Phase 1 trial in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL).
CB-010 is an allogeneic anti-CD19 CAR-T cell therapy.
In the ANTLER dose escalation phase, three dose levels of CB-010 were assessed in patients with multiple subtypes of aggressive r/r B-NHL.
According to the data set of all 16 patients treated in this phase, CB-010 was generally well tolerated and the rate of adverse events was similar with autologous or allogeneic anti-CD19 CAR-T cell therapies.
As reported previously, after single dose-limiting toxicity (DLT) at dose level 1, no DLTs were seen at dose levels 2 or 3.
The overall response rate (ORR) was 94% after a single dose of CB-010. The complete response (CR) was achieved in 69% of patients.
Furthermore, 44% of patients had a CR at ≥6 months; 24 months is the longest CR maintained to date, Caribou Biosciences said.
Additionally, the LBCL patient subgroup had a 90% ORR, 70% of patients achieved a CR, and 50% of individuals achieved a CR at ≥6 months. The longest CR maintained was 18 months to date.
Caribou Biosciences president and CEO Rachel Haurwitz said: “CB-010 dose escalation data rival the responses from autologous cell therapies and demonstrate the potential utility of an off-the-shelf CAR-T cell therapy that could if approved, provide greater access to patients in need.
“We are actively enrolling patients in dose expansion to gain a better understanding of the safety and antitumor activity of CB-010 in a greater number of patients.
“We look forward to determining a recommended Phase 2 dose of CB-010, engaging with the FDA on the next steps, and reporting ANTLER dose expansion data in the first half of 2024.”
Caribou is adding second-line LBCL patients to the ongoing dose expansion phase of the ANTLER clinical trial considering these positive results.
The biopharmaceutical company may include more patients in ANTLER once the RP2D is known. The initial dosage expansion results from the ongoing ANTLER study will be reported by Caribou in H1 2024.