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New treatment option for Cytokine Release Syndrome
Official title Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study
ClinicalTrials.gov ID: NCT07169487
What this study is testing
What is Methylene Blue?
Methylene Blue is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for cytokine release syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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...
- Psychiatric disorders that may interfere with completion of treatment or informed consent.
See the full eligibility criteria
- 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.
- 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...
- Psychiatric disorders that may interfere with completion of treatment or informed consent.
- Any other condition deemed unsuitable for participation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.