FDA clears third IND for Cabaletta’s CAR T-cell drug; trial will enroll patients with SSc
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The FDA has granted an investigational new drug application for CABA-201, a 4-1BB-containing fully human CD19-CAR T-cell therapy, to be studied in patients with systemic sclerosis, according to a press release from its manufacturer.
Cabaletta Bio is now clear to study the therapy in a phase 1/2 trial including two cohorts of patients with SSc. The FDA decision marks the third IND clearance for CABA-201, following similar announcements regarding trials in patients with myositis and lupus, the release said.
“The clearance of our third IND application for CABA-201 within the past 6 months demonstrates our relentless focus on developing CABA-201 for a broad portfolio of potential indications in patients with autoimmune diseases,” Steven Nichtberger, MD, CEO and co-founder of Cabaletta Bio, said in the press release. “We believe CABA-201 has the potential to slow or halt the progression of this autoimmune disease, thereby providing an important treatment option for these patients who currently have very few available treatments.”
The phase 1/2, open-label study will enroll patients with severe skin and organ involvement. Patients will be required to meet disease criteria as it relates to pulmonary, renal or cardiac involvement, the release said.
All participants will receive a single infusion of CABA-201 at a dose of 1x106 cells/kg, and will be pre-treated with a conditioning regimen of fludarabine and cyclophosphamide. Patients will be excluded if they have received a diagnosis of a different rheumatic disease or have undergone B cell-depleting therapy within 6 months of the trial initiation, the release said.
“As the third trial within Cabaletta’s CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy, this study is intended to evaluate the potential ability of CABA-201 to transiently, but completely, eliminate B cells throughout the body, potentially enabling an immune system reset associated with a slowing or halting of active inflammatory disease progression in patients with SSc,” the release said.
The FDA in May granted fast-track designation to CABA-201, for the treatment of systemic lupus erythematous and lupus nephritis. Later that same month, the FDA granted an investigational new drug application for the therapy to be studied in patients with myositis.
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