Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study (NCT07169487) | Clinical Trial Compass
RecruitingPhase 1
Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study
China18 participantsStarted 2025-06-28
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and type of methylene blue-related serious adverse events (SAEs)
Timeframe: Up to Day 35 after initiation of methylene blue treatment
2
Impact of Methylene Blue on CAR-T/T Cell Expansion in Peripheral Blood
Timeframe: Up to Day 35 after initiation of methylene blue treatment
3
Impact of Methylene Blue on CAR-T/T Cell Therapy Efficacy
Timeframe: Baseline to Day 35 post-treatment initiation
Trial details
NCT IDNCT07169487
SponsorInstitute of Hematology & Blood Diseases Hospital, China
. 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.