CIK cell therapy for relapsed or refractory B‑cell acute lymphoblastic leukemia with early CAR‑T dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single‑center, double‑blind, randomized trial enrolling children and adolescent/young adult patients with relapsed or refractory B‑ALL who show early functional exhaustion of prior CAR‑T cells. Eligible participants will be randomly assigned to one of three arms: a control cell group, a CIK cell treatment group, or an mRNA‑modified CIK treatment group. The trial tests the prognostic impact of CIK therapy on early CAR‑T dysfunction, with the primary endpoint being event‑free survival in the CIK treatment arm. A total of 213 subjects will be treated at Beijing GoBroad Hospital using peripheral blood‑derived lymphocyte infusions including CIK and mRNA‑CIK products.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing GoBroad Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Tengyu Wang
• Email: tengyu.wang@gohealtharo.com
• Phone: 86+18333186020

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing CD19 and CD22 CAR T-cell therapies for treating relapsed B-ALL

  This study is testing whether giving patients with relapsed B-cell Acute Lymphoblastic Leukemia two different types of CAR T-cell therapies one after the other works better than just one type followed by a stem cell transplant.

  Recruiting Beijing GoBroad Hospital · Beijing, Beijing Municipality · NCT06343090

• Donor-derived CD19 CAR T cells with allo‑HSCT followed by donor-derived CD22 CAR T cells for relapsed/refractory B‑ALL

  This study tests donor-derived CD19 CAR T cells followed by an allogeneic stem‑cell transplant and sequential donor-derived CD22 CAR T cells in children and adolescents (1–18 years) with relapsed or refractory CD19+/CD22+ B‑ALL who cannot provide their own cells.

  Recruiting Phase 1 Beijing GoBroad Hospital · Beijing, Beijing Municipality · NCT06326008

• CD19 and CD22 in vivo CAR-T therapy for relapsed/refractory B-ALL

  This study tests a one-of-a-kind in vivo CAR-T treatment that targets CD19 first and then CD22 in adults with relapsed or refractory B-ALL to see if it is safe and possibly effective.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07927816

• Umbilical Cord Blood CAR-T Cells Targeting CD19 and CD22 for relapsed/refractory B-ALL

  This phase 1 study tests whether dual-target cord blood-derived CAR-T cells against CD19 and CD22 are safe and tolerable in adults with relapsed or refractory B-cell ALL.

  Recruiting Phase 1 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07838714

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• Dual-target CD22/CD19 CAR-T consolidation after first remission in high-risk B-ALL

  This test will try a dual-target CD22/CD19 CAR-T cell treatment as consolidation for patients with high-risk B-cell acute lymphoblastic leukemia who are in their first remission.

  Recruiting Phase 1/2 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07575971

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.