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

NCT06389305 | Recruiting DMC

• 1 other identifier: BJGBYY-IIT-LCYJ-2024-012
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

B-cell Acute Lymphoblastic Leukemia; Acute Lymphoblastic Leukemia, in Relapse; Refractory Acute Lymphoid Leukemia

Outcome Measures

Primary Outcomes (1)

• Event-free survival(EFS) in CIK infusion group

  EFS is defined as the time from CIK-cell infusion to the earliest relapse, death from any cause, or treatment failure

  2-year EFS rate

Secondary Outcomes (4)

• Progression-free survival(PFS) in CIK infusion group

  2-year PFS rate

• Duration of response(DOR) in CIK infusion group

  from enrollment to the end of treatment at 15 years

• Overall survival(OS) in CIK infusion group

  from enrollment to the end of treatment at 15 years

• EFS in mRNA-CIK infusion group

  2-year EFS rate

Study Arms (2)

peripheral blood lymphocytes

PLACEBO COMPARATOR

Drug: peripheral blood lymphocytes

CIK cells

EXPERIMENTAL

Drug: CIK cell

Interventions

peripheral blood lymphocytes DRUG

autologous or allogeneic peripheral blood lymphocytes

peripheral blood lymphocytes

CIK cell DRUG

autologous or allogeneic cytokine-induced killer (CIK) cells

CIK cells

Eligibility Criteria

• Age: 1 Year - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing GoBroad Hospital: lead

Study Sites (1)

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 102206, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Central Study Contacts

Tengyu Wang

CONTACT

86+18333186020; tengyu.wang@gohealtharo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Dept of Hemato-Oncology and Immunotherapy

Model Details: a prospective cohort study

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: May 27, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)