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

Launched by BEIJING GOBROAD HOSPITAL · Apr 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CIK cell therapy for children and young adults with relapsed or refractory acute B-lymphoblastic leukemia (B-ALL). This is a type of cancer that affects blood cells, and the trial is specifically looking at patients who have experienced early loss of effectiveness from CAR-T cell therapy, a previous treatment option. Participants will be randomly placed into one of three groups: one receiving standard care, one receiving CIK therapy, and another receiving an mRNA version of CIK therapy. The main goal is to see if CIK cell therapy can help improve survival rates without cancer events for these patients.

To be eligible for the trial, participants must be between 1 and 39 years old and have a confirmed diagnosis of relapsed or refractory B-ALL. They should have lost CAR-T cell effectiveness in the past six months but not have experienced a relapse since then. Other criteria include good overall health and the ability to provide consent (or have a guardian provide consent for younger patients). This trial is not yet recruiting, so interested individuals will need to wait for it to begin. If enrolled, participants can expect to be closely monitored and receive additional care as part of the study.

Gender

ALL

Eligibility criteria

• 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.