FDA clears investigational new drug application for ‘switchable’ CAR-T for B-cell malignancies
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The FDA cleared an investigational new drug application for CLBR001 + SWI019 — a “switchable” chimeric antigen receptor T-cell therapy — for the treatment of relapsed or refractory B-cell malignancies, such as non-Hodgkin lymphoma and chronic lymphocytic leukemia, according to a press release issued by the agent’s manufacturer.
CLBR001 + SWI019 (Calibr, AbbVie) is an investigational, anti-CD19, autologous CAR T-cell therapy with a switchable CAR. SWI019 is an antibody Fab-based biologic, called the “switch” by the manufacturer, which targets the B-cell antigen CD19.
The molecular SWI019 switch is designed to eliminate life-threatening toxicities associated with CAR-T cell therapy. These include cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome.
“CLBR001 + SWI019 is a first-in-class, switchable CAR-T cell platform designed to confer the efficacy associated with engineered T-cell therapies, while potentially affording greater safety and versatility through the incorporation of a control switch,” Travis Young, PhD, vice president of biologics and leader of the CAR-T development program at Calibr, said in the press release. “If successful, this approach holds promise to be universally applied to other types of cancer, including solid tumor cancers that have yet to reap the benefits of CAR-T therapies.”
FDA clearance of the investigational new drug application for CLBR001 + SWI019 means Calibr can begin clinical trials to assess the feasibility and safety of the therapy. Enrolment in a phase 1 trial is expected to begin in the second half of this year.
Calibr — the nonprofit, translational drug discovery and development research division of Scripps Research — has partnered with AbbVie on commercial development of the switchable CAR T-cell therapy platform.
“AbbVie continues to be impressed by Calibr’s progress on advancing this innovative switchable cell therapy technology,” Mohit Trikha, PhD, vice president and head of oncology early development at AbbVie, said in the press release. “This milestone is an important step forward for this potential CAR-T therapy and our recently expanded collaboration with Scripps Research, which holds promise to rapidly advance additional treatment options for patients.”