CAR-T cell therapy is being researched among patients with relapsed or refractory B cell non-Hodgkin lymphoma.
Caribou Biosciences – a company focused on genome editing – has announced follow-up data from the dose escalation element of its ongoing ANTLER phase 1 trial.
This new data set includes all 16 patients treated in dose escalation with the CB-010 candidate – an allogeneic anti-CD19 CAR-T cell therapy being researched among patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL).
All of the individuals had aggressive r/r B-NHL and had received two or more prior lines of chemoimmunotherapy or were primary refractory patients.
During the research, three dose levels of CB-010 were evaluated among individuals with multiple subtypes of aggressive r/r B-NHL.
CB-010 was generally well tolerated, with adverse occurrences consistent with autologous or allogeneic anti-CD19 CAR-T cell therapies. Furthermore, no dose-limiting toxicities (DLT) were observed at dose levels two or three following a single DLT at dose level one.
In addition, a 94% overall response rate was observed following a single dose of CB-010, 69% of patients yielded a complete response (CR), and 44% of patients had a CR at greater than six months. A period of 24 months is the longest CR maintained so far.
Following the positive data, Caribou is enrolling second-line patients with LBCL in the continuing dose expansion part of the ANTLER study.
Rachel Haurwitz, president and chief executive officer at Caribou, explained: “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.”
She added: “We are actively enrolling patients in dose expansion to gain a better understanding of the safety and antitumour 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 US Food and Drug Administration on the next steps, and reporting ANTLER dose expansion data in the first half of 2024.”
Loretta Nastoupil, deputy chair and associate professor in the department of lymphoma/myeloma at the University of Texas, reflected: “I am excited to see the initial and durable response rates for patients following a single dose of CB-010 in the ANTLER phase 1 clinical trial. The data is promising and may offer a clinical advantage as an off-the-shelf option compared with approved autologous CAR-T cell therapies.
“In addition to encouraging antitumour activity, CB-010 could provide greater access to patients, including those who are not eligible for or cannot wait for an autologous CAR-T cell therapy.”