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

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About this study

This is a single-center, double-blind, randomized trial. Patients with relapsed or refractory acute B-lymphoblastic leukemia(r/r B-ALL) experiencing early functional exhaustion of CAR-T cells will be randomly allocated into three groups: the control cell group, the CIK treatment group, and the messenger RNA(mRNA)-CIK treatment group. The primary objective of the study is to evaluate the prognostic impact of CIK cell therapy on the early functional exhaustion of CAR-T cells in children and adolescent and young adult (AYA) with r/r B-ALL. The primary endpoint of the study is the event-free survival rate of these patient in the CIK cell therapy group.A total number of 213 subjects will be enrolled.

Condition
B-cell Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, in Relapse, Refractory Acute Lymphoid Leukemia
Tested
peripheral blood lymphocytes, CIK cell
Sponsor
Beijing GoBroad Hospital

Who can join

Age
1 to 39 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 13

  • Minimum age: 1 years
  • Maximum age: 39 years
  • Study condition: B-cell Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, in Relapse, Refractory Acute Lymphoid Leukemia
  • A patient must meet all of the following to be enrolled:
  • 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.
  • Loss of CAR-T cell activity within 6 months after previous CAR-T therapy and no relapse.
  • Age between 1 and 39 years old.
  • No severe allergic constitution.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
  • Life expectancy, as judged by the investigator, of at least 60 days.
  • 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 17

  • A patient with at least one of the following conditions will be excluded:
  • Received bendamustine treatment within the past 9 months;
  • Intracranial hypertension or impaired consciousness in the brain;
  • Symptomatic heart failure or severe arrhythmia;
  • Symptoms of severe respiratory failure;
  • With other types of malignant tumors;
  • Disseminated intravascular coagulation;
  • Serum creatinine and/or blood urea nitrogen ≥ 1.5 times the normal value;
  • Suffering from sepsis or other uncontrollable infections;
  • Uncontrollable diabetes;
  • Severe mental disorders;
  • Significant lesions in the brain as detected by head magnetic resonance imaging;
  • Leukemic cells in the cerebrospinal fluid \>20 cells/μL;
  • Peripheral blood leukemic cell proportion \>30%;
  • Have undergone organ transplantation;
  • Female patients (those with childbearing potential) are pregnant or lactating;
  • Active or uncontrollable infectious diseases, such as hepatitis (HBV, HCV), HIV, or syphilis.

Where

1 site, 1 recruiting

Beijing GoBroad Hospital

Beijing, Beijing Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.