A Single Center, Phase I/II Study of Disulfiram for the Prevention of Immunotoxicity in Patients Undergoing CAR T-Cell Therapy

Summary

This phase I/II trial tests the safety, best dose, and effectiveness of disulfiram for preventing treatment complications in patients with large B-cell lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and who are undergoing chimeric antigen receptor (CAR) T-cell therapy. Two major complications of CAR T-cell therapy include cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). CRS results from inflammation in the body when the immune system responds too aggressively to the modified T cells working to attack cancer cells. ICANS is inflammation of the brain or nerves. CRS is most often a prelude to ICANS, and both of these toxicities currently require immunosuppression for treatment, which can inhibit CAR T-cell response. Disulfiram has been found to impact several biologic pathways that cause CRS. Disulfiram may be safe and effective for reducing the incidence and severity of reactions to CAR T-cell therapy without inhibiting CAR T-cell response.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No