Clinical Trial

Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study

Recruiting Phase 1
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Summary
This Phase I, prospective, single-arm clinical study aims to evaluate the efficacy and safety of adjunctive methylene blue (MB) in patients experiencing cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) following CAR-T cell therapy or bispecific antibody treatment. Preclinical studies demonstrated that MB alleviates CRS/ICANS-related symptoms, preserves the antitumor function of T cells, and modulates neuroinflammation without compromising immune efficacy. The study will employ a 3+3 dose-escalation design with three MB dosing cohorts, with treatment administered intravenously for 3-5 consecutive days. Vital signs, laboratory markers, and neurological status will be closely monitored, and concomitant standard supportive therapies will be permitted.
Trial Details
NCT Number NCT07169487
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions Cytokine Release Syndrome, ICANS
Enrollment 18 participants
Start Date 2025-06-28
Primary Completion 2028-06-28 (estimated)
Study Completion 2030-06-28 (estimated)
Updated on ClinicalTrials.gov 2025-09-11