Phase I/II data for rese-cel point to its therapeutic potential in systemic lupus erythematosus and lupus nephritis, as well as other autoimmune conditions.
With a trio of Phase I/II readouts, Bristol Myers Squibb and Cabaletta Bio are building the case for their CAR T therapy resecabtagene autoleucel as a treatment for a variety of autoimmune conditions.
Data from the RESET clinical program pointed to early signals of efficacy for resecabtagene autoleucel (rese-cel) in patients with a variety of autoimmune conditions, including dermatomyositis (DM), antisynthetase syndrome (ASyS), systemic sclerosis (SSc), lupus nephritis and systemic lupus erythematosus (SLE).
Taken together, these results present an “encouraging” picture of rese-cel as a potential autoimmune agent, particularly given its “immunosuppressant-free” profile, William Blair analysts wrote to investors on Monday.
The partners are gearing up for a registrational trial of rese-cel in myositis, Cabaletta Chief Medical Officer David Chang said in a statement, while the companies are working to align with the FDA “this year” for pivotal study designs in lupus and systemic sclerosis.
In RESET-SLE, Cabaletta reported that three patients with SLE with at least three months of follow-up achieved disease remission after rese-cel treatment, while a fourth participant, who had lupus nephritis, saw a complete renal response. Cabaletta plans to initiate a dose-escalation cohort in this trial, set to start next year.
In the separate Phase I/II RESET- Myositis trial, testing a cohort of six patients—four patients with DM and 2 with ASyS, results showed that four evaluable patients with either DM orASyS demonstrated “moderate or major improvement” after 16 weeks, the companies said in their announcement. Such an improvement occurred without immunomodulators, which according to William Blair de-risks an upcoming registrational cohort for DM.
In line with this, Cabaletta expects to initiate enrollment into this pivotal study this quarter, aiming to recruit 14 patients, in accordance with its previous talks with the FDA.
Similarly, Monday’s RESET-SSc readout comes from four patients with SSc who had at least three months’ worth of follow-up. These initial data show that treatment with rese-cel led to clinical improvements even without immunomodulator and steroid treatment, indicating that the CAR T candidate can “reset” the immune system in patients with SSc, according to Monday’s release.
Data from all three trials were presented at the 2025 congress of the American College of Rheumatology.
Currently, CAR T therapies, which make use of a patient’s own T cells that have been modified to be more potent against a specific target, have been confined to cancer; all FDA-approved products in this class are indicated for malignancies. But following a series of small studies pointing to the potential of this approach to address immune dysfunction, several companies have started leveraging the CAR T platform for autoimmune diseases, with multiple players focusing on conditions like lupus.
