Methylene blue added to treat CAR‑T–related CRS and ICANS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase I, prospective, single‑arm 3+3 dose‑escalation trial testing adjunctive intravenous methylene blue in patients who develop ASTCT grade ≥1 CRS or ICANS after CAR‑T or bispecific antibody therapy. Participants will be enrolled into three escalating dosing cohorts (1, 2, and 3 mg/kg IV once daily) with treatment given for 3–5 consecutive days and close monitoring of vital signs, laboratory inflammatory markers, and neurological status. Dosing decisions will follow standard 3+3 safety rules and concomitant standard supportive treatments (eg, tocilizumab, steroids) are permitted. The trial builds on preclinical data suggesting methylene blue can reduce CRS/ICANS signs and protect neurovascular integrity without impairing T‑cell antitumor activity.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Hematology & Blood Diseases Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Jianxiang Wang — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Jianxiang Wang
• Email: wangjx@ihcams.ac
• Phone: +862223909120

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.