Condition: Cytokine Release Syndrome · ICANS · Sponsor: Institute of Hematology & Blood Diseases Hospital, China
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.
This description comes directly from the study's public registry record.
Jianxiang Wang · +862223909120 · wangjx@ihcams.ac
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| Institute of Hematology & Blood Diseases Hospital | Tianjin, Tianjin Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07169487