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Can a blue dye tame Immunotherapy's dangerous side effects?

NCT ID NCT07169487

Disease control Sponsor: Institute of Hematology & Blood Diseases Hospital, China Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-phase trial tests whether methylene blue, a dye used in medicine for other conditions, can safely treat two serious side effects of certain cancer immunotherapies: cytokine release syndrome (CRS) and immune-related neurotoxicity (ICANS). The study will enroll 18 adults with blood cancers who develop these side effects after CAR-T or bispecific antibody treatment. Participants receive methylene blue infusions for 3-5 days at different doses to find the safest and most promising dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
methylene blue
What this could lead to
If it works, this could offer a new way to manage serious side effects of cancer immunotherapy, potentially making treatment safer and more tolerable.
What could go wrong
This is a very early Phase 1 trial with only 18 people, so it is too soon to know if methylene blue is safe or effective. The results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cytokine release syndrome hematopoietic and lymphoid system neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cytokine release syndrome ICANS

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institute of Hematology & Blood Diseases Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

More trials for these conditions

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