Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study

What Was Tested

This registered phase 1 trial tested Methylene blue (non-peptide stack partner).

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

More on the Plan

This Phase I, prospective, single-arm clinical trial will investigate MB as an adjunctive therapy for immunotherapy-related CRS and ICANS.

Eligible patients are those receiving CAR-T cells or bispecific antibodies who subsequently develop Grade ≥1 CRS or ICANS, as defined by ASTCT 2019 criteria.

Who Took Part

Enrollment: 18 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Ability to understand and sign informed consent and willingness to comply with study requirements.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: glucose-6-phosphate dehydrogenase (g6pd) deficiency; known allergy to methylene blue; pregnant or breastfeeding women.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Methylene blue (non-peptide stack partner) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-06-28 with completion listed for 2028-06-28.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incidence and type of methylene blue-related serious adverse events (SAEs) (time frame: Up to Day 35 after initiation of methylene blue treatment).

It also tracked 5 secondary outcomes, for example Incidence of Grade ≥3 CRS and ICANS, Duration of CRS and ICANS, Duration of corticosteroid use, Proportion of Participants Requiring Vasopressors and Duration of Vasopressor Therapy.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Methylene blue (non-peptide stack partner) in 18 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.