H.C. Wainwright 27th Annual Global Investment Conference: Cabaletta Therapeutics' RESETTM Clinical Trials in Lupus, Myositis, Sclerosis, Myasthenia Gravis, and Pemphigus Vulgaris Now Recruiting

The article discusses the recruitment of patients for clinical trials of CABA-201, an investigational CD19-CAR T cell therapy, in various autoimmune diseases including lupus, myositis, systemic sclerosis, myasthenia gravis, and pemphigus vulgaris. The clinical trials are part of the RESETTM program, which aims to evaluate the safety and efficacy of the therapy.

Jade Biosciences, Inc. (Nasdaq: JBIO), a clinical-stage biotechnology company, has dosed the first cohort of participants in a Phase 1 healthy volunteer trial of JADE101, an investigational monoclonal antibody designed to selectively inhibit the activity of A Proliferation-Inducing Ligand (APRIL) in patients with immunoglobulin A nephropathy (IgAN) [1]. The trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JADE101, which has shown ultra-high binding affinity and a differentiated pharmacokinetic and pharmacodynamic profile preclinically. Interim biomarker-rich Phase 1 data are expected in the first half of 2026, with the goal of defining dose and dosing interval selection based on biomarker responses associated with optimal clinical activity in IgAN patients.

Meanwhile, Lyell Immunopharma, Inc. (Nasdaq: LYEL) has initiated the PiNACLE - H2H Phase 3 clinical trial, a head-to-head randomized controlled trial evaluating rondecabtagene autoleucel (ronde-cel) versus investigator’s choice of approved CD19 CAR T-cell therapies in patients with aggressive large B-cell lymphoma receiving treatment in the second line (2L) setting [2]. The trial aims to assess the efficacy and safety of ronde-cel, a dual-targeting CD19/CD20 CAR T-cell therapy, compared to currently approved CD19 CAR T-cell therapies.

References:
[1] https://www.biospace.com/press-releases/jade-biosciences-announces-first-cohort-dosed-in-phase-1-healthy-volunteer-clinical-trial-of-jade101-a-novel-and-potentially-best-in-class-anti-april-monoclonal-antibody-being-evaluated-for-the-treatment-of-iga-nephropathy
[2] https://www.biospace.com/press-releases/lyell-immunopharma-announces-the-initiation-of-a-phase-3-head-to-head-car-t-cell-therapy-clinical-trial-in-aggressive-large-b-cell-lymphoma-and-formation-of-expert-steering-committee