NCT07169487 Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study
| NCT ID | NCT07169487 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Cytokine Release Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2025-06-28 |
| Primary Completion | 2028-06-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2025-06-28 with a primary completion date of 2028-06-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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 participants of childbearing potential agree to use effective contraception. 5. Left ventricular ejection fraction (LVEF) \>45% by echocardiography. 6. Ability to understand and sign informed consent and willingness to comply with study requirements. Exclusion Criteria: 1. Glucose-6-phosphate dehydrogenase (G6PD) deficiency. 2. Known allergy to methylene blue. 3. Pregnant or breastfeeding women. 4. Known HIV seropositivity. HIV testing may be required according to local laws or regulations. 5. 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). 6. Psychiatric disorders that may interfere with completion of treatment or informed consent. 7. Any other condition deemed unsuitable for participation by the investigator.
Contact & Investigator
Jianxiang Wang
PRINCIPAL INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Frequently Asked Questions
Who can join the NCT07169487 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cytokine Release Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07169487 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07169487 currently recruiting?
Yes, NCT07169487 is actively recruiting participants. Contact the research team at wangjx@ihcams.ac for enrollment information.
Where is the NCT07169487 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07169487 clinical trial?
NCT07169487 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Jianxiang Wang at Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 18 participants.