Cabaletta Bio (CABA) has unveiled promising initial data from the RESET-PV trial, which evaluated rese-cel at a dosage of 1 x 106 cells/kg without the use of preconditioning treatments in patients with pemphigus vulgaris. This information was highlighted in a late-breaking oral presentation by Cabaletta's Chief Scientific Officer, Dr. Samik Basu, at the 2025 European Society of Gene & Cell Therapy Annual Congress in Seville, Spain.
The trial is a pioneering study in Cabaletta's RESET program, as it assesses the potential of rese-cel without relying on cyclophosphamide and fludarabine for preconditioning. Key insights from the data cut-off date of September 11, 2025, revealed that rese-cel demonstrated similar kinetics in CAR T cell expansion and contraction compared to other RESET trials that included preconditioning.
Notably, all three patients experienced significant B cell depletion soon after infusion. Patients 2 and 3 achieved complete depletion, alongside a marked reduction in autoantibodies and manageable levels of B cell activating factor. Rese-cel was well-tolerated, with no reports of neurotoxicity. Patient 1 had a temporary fever, while Patient 2 required steroids for a mild flare but later tapered off.
Encouraging clinical responses were observed within the first month, as reflected in improved Pemphigus Disease Area Index (PDAI) scores. Patient 1's score dropped from 24 to 10, Patient 2 from 83 to 3, and Patient 3 from 22 to 2. These scores suggest significant skin and mucosal improvements, supporting further exploration of preconditioning removal in the RESET program.
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