Can immune booster cells revive failing CAR-T therapy in leukemia?
NCT ID NCT06389305
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding cytokine-induced killer (CIK) cells can prevent CAR-T cells from wearing out too early in children and young adults with relapsed or hard-to-treat B-cell acute lymphoblastic leukemia. About 213 participants will be randomly assigned to receive either control cells, CIK cells, or enhanced mRNA-CIK cells. The main goal is to see if CIK therapy improves how long patients stay free of relapse or treatment failure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 213 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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May 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 39 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: * A patient must meet all of the following to be enrolled: 1. A confirmed diagnosis of refractory or relapsed B-ALL (criteria reference: NCCN, 2024.4), where all patients meet the National Comprehensive Cancer Network(NCCN) guidelines for the diagnosis of acute lymphoblastic leukemia (hematopathological examination of bone marrow aspirate and biopsy tissue showing ≥20% lymphoblasts in the bone marrow, confirmed by comprehensive flow cytometry (FCM) immunotyping, minimal residual disease analysis, and G-banded metaphase chromosome karyotype analysis). Molecular characteristics can be described through methods such as interphase fluorescence in situ hybridization (FISH) testing, reverse transcription polymerase chain reaction (RT-PCR) testing, and next-generation sequencing (NGS) for comprehensive detection of fusion genes and pathogenic mutations. Determination can also be made by the World Health Organization's subtypes of acute lymphoblastic leukemia, as well as cytogenetic and clinical risk groups. 2. Loss of CAR-T cell activity within 6 months after previous CAR-T therapy and no relapse. 3. Age between 1 and 39 years old. 4. No severe allergic constitution. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 6. Life expectancy, as judged by the investigator, of at least 60 days. 7. Patients with self-awareness between 8 and 39 years of age voluntarily sign an informed consent, and the legal representative (guardians) of child patients under 18 years of age voluntarily signs an informed consent. Exclusion Criteria: * A patient with at least one of the following conditions will be excluded: 1. Received bendamustine treatment within the past 9 months; 2. Intracranial hypertension or impaired consciousness in the brain; 3. Symptomatic heart failure or severe arrhythmia; 4. Symptoms of severe respiratory failure; 5. With other types of malignant tumors; 6. Disseminated intravascular coagulation; 7. Serum creatinine and/or blood urea nitrogen ≥ 1.5 times the normal value; 8. Suffering from sepsis or other uncontrollable infections; 9. Uncontrollable diabetes; 10. Severe mental disorders; 11. Significant lesions in the brain as detected by head magnetic resonance imaging; 12. Leukemic cells in the cerebrospinal fluid \>20 cells/μL; 13. Peripheral blood leukemic cell proportion \>30%; 14. Have undergone organ transplantation; 15. Female patients (those with childbearing potential) are pregnant or lactating; 16. Active or uncontrollable infectious diseases, such as hepatitis (HBV, HCV), HIV, or syphilis.
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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.
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- 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?
- Can a Chemo-Antibody combo beat a tough leukemia?