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Engineered immune cells take on rare blood disorders

NCT ID NCT07603557

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jul 10, 2026 · Updated 4 times

Summary

This phase 2 trial tests a personalized CAR T cell therapy called zolacabtagene autoleucel in 52 adults with chronic immune thrombocytopenia (ITP) or autoimmune hemolytic anemia (AIHA). The treatment uses the patient's own immune cells, modified to target and destroy faulty B cells that attack blood cells. The study aims to see if this approach can safely improve blood counts and reduce symptoms.

What this could mean

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

Active substance
zolacabtagene autoleucel (a CAR T cell therapy made from the patient's own immune cells)
What this could lead to
If it works, this could offer a new treatment option for people with chronic ITP or AIHA who have not responded to other therapies, potentially reducing the need for ongoing medication.
What could go wrong
This is an early phase 2 trial with only 52 participants, so results may not apply to everyone. CAR T cell therapy can cause serious side effects like cytokine release syndrome and neurological problems.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 52 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

May 2030

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 Inclusion Criteria for ITP * Documented clinical diagnosis of chronic ITP (cITP) without other clinical manifestations of systemic autoimmune disease. * Has relapsed after or is intolerant to corticosteroids (with or without intravenous immunoglobulin (IVIG) or anti-Rh0(D) Ig) AND has failed, relapsed after, or is intolerant to therapies with ≥ 2 mechanisms of action, with at least one being immunosuppressive or immunomodulatory. Platelet count \< 30 × 109/L. For participants on thrombopoietin receptor agonist (TPO-RA): platelet count \< 50 × 109/L. Inclusion Criteria for AIHA * Documented clinical diagnosis of AIHA (including warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (CAD), or mixed AIHA) without other clinical manifestations of systemic autoimmune disease. o wAIHA and mixed warm and cold AIHA: Failed, relapsed after, or is intolerant to at least 2 prior lines of treatment with 2 mechanisms of action (not including corticosteroids or IVIG), one of which is an anti-CD20 monoclonal antibody unless there is a documented contraindication. o CAD (all of the following must apply): Failed, relapsed after, or is intolerant to at least 2 prior lines of treatment with 2 mechanisms of action, one of which is an anti-CD20 monoclonal antibody with or without chemotherapy unless there is a documented contraindication. * Hb \<10 g/dL without red blood cell transfusion, or transfusion dependent * Documented hemolysis Exclusion Criteria Medical Conditions * ITP or AIHA associated with: Evans syndrome, other systemic autoimmune disease or single organ autoimmune disease requiring systemic immunosuppressive therapy, hepatitis C virus, HIV, drug induced (eg, non-steroidal anti-inflammatory drug (NSAIDS), trimethoprim/sulfamethoxazole (TMP-SMX), anticonvulsants), surgical procedures, or hematologic malignancies. * COVID-19 Vaccine-induced immune thrombotic thrombocytopenia * Prior history of solid organ malignancies, unless the participant has been free of the disease for ≥ 2 years. Laboratory Test Findings * Peripheral blood ANC \< 1.5 × 109/L or requiring G-CSF or GM-CSF support o ALT/AST: ITP: ALT/AST: \> 3 × ULN AIHA: ALT \> 3 ULN. AST up to 5 × ULN may be permitted. o Bilirubin: ITP: total bilirubin \> 1.5 × ULN AIHA: direct bilirubin \> 1.5 × ULN o International normalized ratio (INR) \> 1.5 × ULN Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    8 sites in 4 countries. 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

  • Local Institution - 101

    Boston, Massachusetts, 02114, United States

  • Local Institution - 102

    Seattle, Washington, 98109, United States

  • Local Institution - 103

    Houston, Texas, 77030-2740, United States

  • Local Institution - 201

    Odense, DK-5000, Denmark

  • Local Institution - 301

    Magdeburg, Saxony-Anhalt, 39120, Germany

  • Local Institution - 302

    Erlangen, 91054, Germany

  • Local Institution - 401

    London, Greater London, W12 OHS, United Kingdom

  • Local Institution - 402

    Sheffield, S10 2SJ, United Kingdom

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