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Open-label phase 1/2 clinical trial to evaluate the safety and efficacy of autologous CD19-specific chimeric antigen receptor T cells (CABA-201).
THE OBJECTIVE OF THIS STUDY IS TO DETERMINE WHAT DOSE OF THE STUDY DRUG, CALLED “CABA-201,” CAN BE SAFELY ADMINISTERED TO PATIENTS WITH IDIOPATHIC INFLAMMATORY MYOPATHY (IIM) AND JUVENILE IDIOPATHIC INFLAMMATORY MYOPATHY (JIIM) OR MYOSITIS. ALTHOUGH THE CAUSE IS NOT WELL UNDERSTOOD, JIIM AND SOME SUBTYPES OF IIM, INCLUDING DERMATOMYOSITIS (DM), ANTISYNTHETASE SYNDROME (ASYS), AND IMMUNE-MEDIATED NECROTIZING MYOPATHY (IMNM), ARE BELIEVED TO INVOLVE B CELLS, WHICH CAUSE THE BODY TO ATTACK DIFFERENT TISSUES, LEADING TO INFLAMMATION AND MUSCLE WEAKNESS.
Technical Summary
- OPEN-LABEL PHASE 1/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF AUTOLOGOUS CD19-SPECIFIC CHIMERIC ANTIGEN RECEPTOR T CELLS (CABA-201) IN SUBJECTS WITH ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHY OR ACTIVE JUVENILE IDIOPATHIC INFLAMMATORY MYOPATHY.
- Code EudraCT: 2025-521145-24-00
- Protocol number: CAB-201-002
- Promoter: Cabaletta Bio, Inc
- Molecule/Drug: CABA-201
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