Actively Recruiting
Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-09-11
18
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hematologic malignancies confirmed by cytomorphology and immunophenotyping; age 18 years or older
- Received immunotherapy such as CAR-T cells or bispecific antibodies and developed Grade 1 or higher CRS or ICANS
- Have an expected life expectancy of 3 months or more
- Male and female participants of childbearing potential agree to use effective contraception
- Left ventricular ejection fraction (LVEF) greater than 45% by echocardiography
- Ability to understand and sign informed consent and willingness to follow study requirements
You will not qualify if you...
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Known allergy to methylene blue
- Pregnant or breastfeeding women
- Known HIV positive status; testing may be required based on local regulations
- History of serious ventricular arrhythmia, unexplained syncope (not vasovagal), sinoatrial block, or higher-degree AV block with chronic slow heart rate unless a permanent pacemaker is implanted
- Psychiatric conditions that could interfere with study treatment or consent
- Any other condition the investigator judges makes participation unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
J
Jianxiang Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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