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Keto diet may supercharge cancer immunotherapy, early trial hints

NCT ID NCT07564219

Disease control Sponsor: Universitätsklinikum Hamburg-Eppendorf 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether raising blood levels of a natural molecule called beta-hydroxybutyrate (BHB) — through a strict ketogenic diet or ketone drinks — is safe and can improve the effectiveness of immunotherapy (CAR-T cells or bispecific antibodies) in 45 adults with multiple myeloma. Participants are randomly assigned to one of four intervention groups or a control group for 28 days. The goal is to see if this metabolic boost can enhance T-cell function without causing severe side effects.

What this could mean

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

Active substance
Ketogenic diet and ketone monoester supplements
What this could lead to
If successful, this could show that raising BHB levels safely enhances T-cell function, potentially improving outcomes for multiple myeloma patients on immunotherapy.
What could go wrong
This is an early, small study (45 participants) testing feasibility and safety, not efficacy. The diet or supplements may be hard to tolerate, and results may not lead to better cancer control.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 45 people

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

Started

Jan 2026

Expected to finish

Dec 2028

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: * Multiple Myeloma with indication for CAR-T cell therapy with Ciltacabtagene autoleucel (target antigen: BCMA) or a BCMA-directed bispecific antibody (e.g., Teclistamab, Elranatamab, Linvoseltamab). * Age ≥18 years on the day the informed consent is signed. Exclusion Criteria: * Active infection requiring systemic therapy. * Known history of infection with Human Immunodeficiency Virus (HIV) or Hepatitis. * Significant short-term weight loss (\>10% within the last 6 weeks). * ECOG Performance Status ≥2. * Prior immunoeffector cell therapy (CAR-T cell therapy or bispecific antibodies). * Active immunosuppression due to another condition (e.g., autoimmune disease, second malignancy). * Very high tumor burden with high risk for tumor lysis syndrome, as determined by myeloma-specific markers or markedly elevated LDH (per the treating myeloma team). * Women of childbearing potential in whom pregnancy cannot be reliably excluded prior to study entry.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Bispecific antibodies Car-T cells Multiple myeloma (MM)

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

  • University Medical Center Hamburg-Eppendorf

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 20251, Germany

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