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

Recruiting now · Phase 1

Conditions studied: Cytokine Release Syndrome, ICANS

In brief

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.

Key facts

Study ID

NCT07169487

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

18

Starts

2025-06-28

Expected to finish

2030-06-28

Last updated by the study team

2025-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• Known allergy to methylene blue.
• Pregnant or breastfeeding women.
• Known HIV seropositivity. HIV testing may be required according to local laws or regulations.
• 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.

Where it is running

• Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin Municipality, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.