🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 1Ages 18 Years - anyAllInstitute of Hematology & Blood Diseases Hospital…
NCT07169487 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
Inclusion Criteria: 1. Diagnosed with hematologic malignancies based on cytomorphology and immunophenotyping; age ≥18 years. 2. Received immunotherapy (e.g., CAR-T cells, bispecific antibodies) and developed CRS or ICANS of ASTCT Grade ≥1. 3. Estimated life expectancy ≥3 months. 4. Male and female participants of childbearing potential agree to use effective contraception. 5. Left ventricular ejection fraction (LVEF) \>45% by echocardiography. 6. Ability to understand and sign informed consent and willingness to comply with study requirements. Exclusion Criteria: 1. Glucose-6-phosphate dehydrogenase (G6PD) deficiency. 2. Known allergy to methylene blue. 3. Pregnant or breastfeeding women. 4. Known HIV seropositivity. HIV testing may be required according to local laws or regulations. 5. 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). 6. Psychiatric disorders that may interfere with completion of treatment or informed consent. 7. Any other condition deemed unsuitable for participation by the investigator.
💊

What it tests

  • Methylene Blue
📍

Where

1 site
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy