CD19-CAR T Cell Therapy Fast Tracked for Systemic Lupus Erythematosus

ASCT remains the only curative therapy for patients with MDS.
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CABA-201 is a 4-1BB-containing fully human CD19-CAR T cell therapy.

The Food and Drug Administration (FDA) has granted Fast Track designation to CABA-201 for the treatment of systemic lupus erythematosus (SLE) and lupus nephritis.

CABA-201 is a 4-1BB-containing fully human CD19-chimeric antigen receptor (CAR) T cell investigational therapy. SLE is characterized by abnormal B cell function and autoantibody production. CABA-201 is a one-time infusion designed to deplete CD19-positive B cells, thereby improving disease activity in patients with SLE and lupus nephritis.

An open-label, phase 1/2 clinical trial has been cleared to begin and will include 6 patients with SLE with active lupus nephritis, as well as 6 SLE patients without renal involvement. Prior to infusion with CAB-201, study participants will be treated with a standard preconditioning regimen that includes fludarabine and cyclophosphamide.

“We believe the FDA’s decision to grant Fast Track designation for CABA-201 underscores the unmet need for a treatment that has the potential to provide deep and durable responses for people living with lupus and potentially other autoimmune diseases where B cells contribute to disease,” said David J. Chang, MD, Chief Medical Officer of Cabaletta. “We look forward to initiating the phase 1/2 trial for CABA-201 and further evaluating its therapeutic potential for patients in need.”

Treatment with anti-CD19 CAR T cell therapy led to remission in 5 patients with active SLE who where refractory to several immunosuppressive treatments, according to results from a small study. Findings also showed that the treatment was well tolerated; cytokine release syndrome was reported to be mild.


  1. Cabaletta Bio receives FDA Fast Track designation for CABA-201. News release. Cabaletta Bio. May 1, 2023. Accessed May 2, 2023.
  2. Mackensen A, Müller F, Mougiakakos D, et al. Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus. Nature Medicine. Published online September 15, 2022. Accessed May 2, 2023.