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Donor immune cells take on tough leukemia in early trial

NCT ID NCT06326008

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests a two-step approach for people with B-cell acute lymphoblastic leukemia that has come back or not responded to treatment. First, patients receive donor-derived CD19 CAR T cells, then a stem cell transplant from the same donor, followed by donor-derived CD22 CAR T cells. The goal is to see if this combination is safe and tolerable. About 48 participants will be enrolled to assess side effects and begin to look at how well it works.

What this could mean

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

Active substance
donor-derived CD19 and CD22 CAR T cells
What this could lead to
If successful, this could offer a new treatment option for patients with hard-to-treat B-cell acute lymphoblastic leukemia who have run out of standard therapies.
What could go wrong
This is a very early phase 1 trial with only 48 participants, so safety and effectiveness are not yet proven. There are risks of serious side effects from the CAR T cells and stem cell transplant, including graft-versus-host disease.

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 48 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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

1 year to 18 years

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: \- Patients will be enrolled only if they meet all the inclusion criteria. 1. Patients with relapsed or refractory CD19+/CD22+ (FCM \>95%) B-cell acute lymphoblastic leukaemia who have progressed despite or are intolerant to all standard therapies, including, but not limited to, immunotherapies such as Blinatumomab (BITE), Tyrosine kinase inhibitors (TKI), CAR T-cell therapy, etc.; Currently available therapies have a limited prognosis and there are no available curative treatment options (e.g., HSCT or chemotherapy); 2. Peripheral blood tumour burden ≥60% or severe peripheral blood cytopenia, unsuitable/unable to collect autologous lymphocytes; 3. 1 to 18 years old; 4. Patient's expected survival time ≥ 60 days; 5. Physical status: ECOG score 0-2; 6. Availability of allogeneic donors (HLA-identical or HLA-haploidentical) DSA-negative for collection of peripheral blood mononuclear cells and peripheral blood stem cells; 7. Sign an informed consent form during the screening period. Pediatric patients under 8\~18 years of age need to have sufficient awareness to voluntarily sign an informed consent form, and their legal representatives (guardians) also need to voluntarily sign an informed consent form; pediatric patients aged 1\~7 years can only be recruited after their legal guardians have voluntarily signed an informed consent form. Exclusion Criteria: * Patients who meet any of the following criteria are not eligible for enrolment. 1. Patients who have received previous haematopoietic stem cell transplantation (including peripheral blood haematopoietic stem cell transplantation and bone marrow haematopoietic stem cell transplantation); 2. Intracranial hypertension or cerebral impaired consciousness; 3. Symptomatic heart failure or severe cardiac arrhythmia; 4. Symptoms of severe respiratory failure; 5. With other types of malignant tumours; 6. Diffuse intravascular coagulation; 7. Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value; 8. Suffering from sepsis or other uncontrollable infections; 9. Suffering from uncontrollable diabetes mellitus; 10. Severe mental disorders; 11. Have significant intracranial lesions on cranial MRI (excluding intracranial masses caused by central nervous system leukaemia); 12. Have organ transplant history; 13. Female patients (patients of childbearing potential) with positive blood HCG test; 14. Hepatitis (including Hepatitis B and Hepatitis C) and positive screening for AIDS and syphilis; 15. No allogeneic donor suitable for collection of peripheral blood lymphocytes and haematopoietic stem cells.

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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

    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

  • Beijing GoBroad Hospital

    RECRUITING

    Beijing, Beijing Municipality, 102206, China

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