Status:
RECRUITING
Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Cytokine Release Syndrome
ICANS
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 effec...
Detailed Description
Methylene blue (MB), originally approved for methemoglobinemia, has demonstrated hemodynamic and neuroprotective effects. Preclinical data indicate that MB alleviates CRS/ICANS symptoms, protects bloo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 28 2030
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT07169487
Start Date
June 28 2025
End Date
June 28 2030
Last Update
September 11 2025
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China