Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China
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, 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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Methylene Blue
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov