Methylene Blue for Cytokine Release Syndrome and ICANS
Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study
Recruiting
Phase 1
Interventional Study
Cytokine Release Syndrome
ICANS
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 18 (estimated)
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China · Other
Who this trial is looking for
This trial is looking for adults with blood cancers who have developed symptoms of cytokine release syndrome or neurotoxicity after immunotherapy. Participants will receive intravenous methylene blue for several days while their health is monitored.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 18 years old.
- I have been diagnosed with a blood cancer.
- I have received immunotherapy and have CRS or ICANS symptoms.
- I expect to live for at least 3 more months.
- I will use effective contraception if I can get pregnant.
- My heart function is normal as shown by an echocardiogram.
- I can understand and sign the consent form.
You may not be able to join if
- I have glucose-6-phosphate dehydrogenase deficiency.
- I am allergic to methylene blue.
- I am pregnant or breastfeeding.
- I have tested positive for HIV.
- I have a history of serious heart rhythm problems.
- I have a psychiatric disorder that would interfere with the study.
- I have a condition that the doctor thinks makes me unsuitable for the trial.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
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About This Trial
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, preser…
Trial Locations
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Eligibility Criteria
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 …
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