gMG is a B-cell-mediated disease; most patients have detectable autoantibodies targeting the neuromuscular junction. Most available therapies require chronic administration, increasing the risk of side effects, and many patients remain refractory despite several treatments. Rese-cel is an investigational, fully human, autologous 4-1BB CD19-CAR T cell therapy, designed to deeply and transiently deplete CD19+ B-cells following a single, weight-based infusion, potentially enabling an “immune reset” with durable responses.

Eligible patients are 18-70 years old with MGFA Classification II-IV gMG and MG-ADL ≥6 despite ≥2 prior/current treatments.

As of September 2025, four patients (2 per cohort) have received rese-cel and completed ≥1 month follow-up. Grade 2 cytokine release syndrome occurred in 1 patient.

The 2 evaluable patients achieved MG-ADL improvements from 17 to 0 (achieving minimal symptom expression) and 14 to 7, off all gMG medications, at 20- and 8-weeks post-infusion, respectively. The 3rd patient is not evaluable due to use of a prohibited cytotoxic medication that may have inhibited CAR T activity; the 4th patient has insufficient follow up.

Rese-cel peaked by Day 14 and B-cells were depleted by Day 8 in all patients. Serum BAFF concentrations peaked following B-cell depletion. In the first treated patient, B-cells repopulated by Week 12 with predominantly transitional naïve cells (CD24⁺⁺/CD38⁺⁺). 

These initial data suggest that rese-cel is well-tolerated and can cause immune reset in gMG, allowing patients to achieve meaningful clinical responses off gMG therapies. Both cohorts are fully enrolled, with post-treatment data forthcoming.