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Can a One-Time cell therapy reset the immune system in autoimmune disease?

NCT ID NCT07778446

Cure Sponsor: Myeloid Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial is testing an experimental treatment called CRT-402 for people with severe autoimmune diseases like lupus, scleroderma, and myositis that haven't improved with standard therapies. CRT-402 is a type of CAR-T cell therapy given by infusion that aims to deplete certain immune cells (B cells) and potentially reset the immune system. The study will evaluate the safety, tolerability, and preliminary effectiveness of this approach in about 34 adults.

What this could mean

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

Active substance
CRT-402, an in vivo CD19-targeted CAR-T cell therapy
What this could lead to
If successful, this could lead to a one-time treatment that resets the immune system, potentially offering long-term remission for people with severe autoimmune diseases.
What could go wrong
This is an early-stage trial, so safety and effectiveness are not yet proven. There are risks of serious side effects like cytokine release syndrome and neurotoxicity.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 34 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Age 18 years or older. * Diagnosis of active, refractory systemic lupus erythematosus, systemic sclerosis, or idiopathic inflammatory myopathy meeting established classification criteria, with inadequate response or intolerance to standard therapy. * Adequate renal, hepatic, cardiac, and pulmonary function per protocol-defined criteria. * Participants of reproductive potential must agree to use protocol-specified contraception during the study and for a defined period after dosing. * Females of childbearing potential must have a negative pregnancy test before treatment. * Must be willing and able to attend study visits and follow all study requirements. Exclusion Criteria: * Clinical suitability for a less burdensome and/or approved therapeutic approach, as judged by the Investigator, * Any medical condition or laboratory abnormality that, in the Investigator's judgment, would place the participant at unacceptable risk or confound interpretation of study data, * Prior Cluster of differentiation 19 (CD19)-directed, cell, or gene therapy, * History of bone marrow/ hematopoietic stem cell or solid organ transplantation, * Active or inadequately treated infection, including Human immunodeficiency (HIV), hepatitis B or C, or tuberculosis, * Pregnancy or lactation.

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Conditions

The condition(s) this trial relates to.

autoimmune disease idiopathic inflammatory myopathy juvenile dermatomyositis myositis disease systemic lupus erythematosus systemic sclerosis

As listed by the trial registrant

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

Autoimmune diseases Myositis Systemic lupus erythematosus Systemic scleroderma

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

  • Linear Advanced Clinical Trial Centre, Ground Floor, B Block, Queen Elizabeth II Medical Centre, Hospital Avenue

    Nedlands, Western Australia, 6009, Australia

More trials for these conditions

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