Cabaletta’s IND Application for CABA-201 Receives the US FDA’s Approval for the Treatment of Generalized Myasthenia Gravis (gMG)
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- Following the IND approval, the company plans to initiate a P-I/II clinical trial which evaluates CABA-201 (1 x 106 cells/kg) in patients with gMG across 2 parallel cohorts of which 1 includes patients (n=6 & 6, aged 18-70yrs.) with AChR Ab+ & AChR Ab- gMG
- CABA-201 is also being assessed in patients with lupus, myositis & systemic sclerosis & the company is expanding the evaluation of CABA-201 beyond rheumatology & into neurology. The FDA approved the company's IND application for lupus, myositis & systemic sclerosis
- Cabaletta expects to report the initial clinical data for CABA-201 in gMG by H1’24 along with the data for lupus and/or myositis trials. CABA-201 is a 4-1BB-containing fully human CD19-CAR T cell
Ref: Cabaletta | Image: Cabaletta
Related News:- UCB Receive the US FDA’s Approval of Zilbrysq (zilucoplan) for the Treatment of Adults with Generalized Myasthenia Gravis
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
