Donor immune cells take on tough leukemia in early trial
NCT ID NCT06326008
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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1 year to 18 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Beijing GoBroad Hospital
RECRUITINGBeijing, Beijing Municipality, 102206, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental therapy SNC116 put to the test against Hard-to-Treat leukemia
- Can a Pre-Transplant drug keep leukemia from returning?
- Fighting fat to fight leukemia: could a diet and exercise plan boost chemo?
- Can a new combo drug tame childhood leukemia that Won't quit?
- Can donor immune cells be engineered to fight blood cancer?
- Can we make CAR-T cells last longer in leukemia?