CIK Cell Therapy for Relapsed or Refractory Acute B-Lymphoblastic Leukemia: Prognostic Impact on Patients With Early CAR-T Cell Dysfunction

Plain-language summary

This single-center, double-blind, randomized trial studies CIK cell therapy in patients with relapsed or refractory acute B-lymphoblastic leukemia (r/r B-ALL) who experience early functional exhaustion of CAR-T cells. Participants are randomly assigned to a control cell group, a CIK treatment group or an mRNA-CIK treatment group. A total of 213 children and adolescent and young adult (AYA) participants are planned, with event-free survival rate as the primary endpoint.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

Beijing GoBroad Hospital

Intervention

peripheral blood lymphocytes, CIK cell

Start date

5/27/2024

Estimated completion

5/30/2026

Countries

China

Locations

• Beijing, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.