Disulfiram for Preventing Treatment Complications in Patients Undergoing CAR T-cell Therapy for Relapsed or Refractory Diffuse Large B-cell Lymphoma
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Official title
A Single Center, Phase I/II Study of Disulfiram for the Prevention of Immunotoxicity in Patients Undergoing CAR T-Cell Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07932730
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 12 participants
Conditions and interventions
Interventions
- Axicabtagene Ciloleucel Biological
- Biospecimen Collection Procedure
- Computed Tomography Procedure
- Cyclophosphamide Drug
- Disulfiram Drug
- Fludarabine Drug
- Positron Emission Tomography Procedure
Biological · Procedure · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2026 (Estimated)
- Primary completion
- May 2028 (Estimated)
- Completion
- May 2028 (Estimated)
- Last update posted
- Nov 12, 2026
2026 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07932730, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 12, 2026 · Synced Nov 12, 2026
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