FDA grants fast-track designation to potential CD19-CAR T cell therapy for lupus
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Key takeaways:
- The therapy will be evaluated in a phase 1/2 trial including patients with systemic lupus erythematosus, lupus nephritis.
- The first trial will include 12 patients.
The FDA has granted fast-track designation to CABA-201, a CD19-CAR T cell investigational therapy, for the treatment of systemic lupus erythematous and lupus nephritis, according to a press release from the manufacturer.
CABA-201 (Cabaletta Bio) is a 4-1BB-containing fully human CD19-CAR T cell investigational therapy intended to deplete CD19-positive B cells in an effort to reduce the burden of disease activity in patients with SLE as well as lupus nephritis, the company stated.
“Existing therapies typically result in general immunosuppression, require chronic administration, and are often administered in conjunction with steroids and other immunosuppressive medications to reduce disease burden, which can leave patients with continued disease activity, treatment-associated side effects, and impaired quality of life,” David J. Chang, MD, chief medical officer of Cabaletta, said in the release.
“We believe the FDA’s decision to grant fast track Designation for CABA-201 underscores the unmet need for a treatment that has the potential to provide deep and durable responses for people living with lupus and potentially other autoimmune diseases where B cells contribute to disease,” he added.
According to the release, Cabaletta Bio has received approval to initiate a phase 1/2 trial investigating the therapy in patients with SLE and lupus nephritis. The trial will be an open-label study and will include two parallel cohorts of six patients each. One cohort will include patients with SLE without renal involvement, and the second will feature patients with SLE with active lupus nephritis.
The therapy is intended to be administered as a one-time infusion, where the therapy’s efficiency in the elimination of B cells can be evaluated, the release said. CABA-201 will be given at a dose of 1x106 cells/kg during the study.
FDA fast track designation is intended to expedite the development and review of drugs that fulfill an unmet need in serious diseases. Benefits of the designation include the potential for more frequent meetings with the FDA during clinical development, eligibility for accelerated approval or priority review, and the ability to submit sections of a biologics license application on a rolling basis.
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Cabaletta Bio press release
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