FDA grants fast track designation to ‘switchable’ CAR-T for B-cell malignancies
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The FDA granted fast track designation to CLBR001 + SWI019, a chimeric antigen receptor T-cell therapy designed to treat B-cell malignancies, according to the agent’s developer.
CLBR001 + SWI019 (Calibr/AbbVie) is an investigational anti-CD19, autologous CAR T-cell therapy with a “switchable” CAR.
SWI019 — an antigen-binding fragment (Fab)-based biologic — acts as a switch that activates the CLBR001 engineered cells and directs them to target 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.
“[FDA fast track] designation will enable Calibr to interact with the agency on study-related items, such as appropriate data collection and study design to support the approval of this innovative therapy,” Pamela Garzone, PhD, chief medical officer of Calibr, said in a company-issued press release.
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.
“The versatility and potential for greater safety enabled by this switchable platform can yield significant benefits for patients and we look forward to the opportunity to accelerate its development,” Travis Young, PhD, Calibr’s vice president of biologics and leader of its CAR-T program, said in the release.
Enrollment is underway for a phase 1 multicenter, open-label, dose-escalation clinical trial to assess the safety and feasibility of CLBR001 + SWI019.
The study will enroll adults with relapsed or refractory B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, chronic lymphocytic leukemia, marginal zone lymphoma, mantle cell lymphoma, small lymphocytic lymphoma, primary mediastinal large B-cell lymphoma and transformed follicular lymphoma.
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