Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study (NCT07169487) | Clinical Trial Compass
RecruitingPhase 1
Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study
China18 participantsStarted 2025-06-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Diagnosed with hematologic malignancies based on cytomorphology and immunophenotyping; age ≥18 years.
✓. Received immunotherapy (e.g., CAR-T cells, bispecific antibodies) and developed CRS or ICANS of ASTCT Grade ≥1.
✓. Estimated life expectancy ≥3 months.
✓. Male and female participants of childbearing potential agree to use effective contraception.
✓. Left ventricular ejection fraction (LVEF) \>45% by echocardiography.
✓. Ability to understand and sign informed consent and willingness to comply with study requirements.
✕. History of clinically significant ventricular arrhythmia, unexplained syncope (not vasovagal), sinoatrial block, or higher-degree atrioventricular (AV) block with chronic bradycardia (unless a permanent pacemaker is implanted).
✕. Psychiatric disorders that may interfere with completion of treatment or informed consent.
✕. Any other condition deemed unsuitable for participation by the investigator.