CIK Cell Therapy for Relapsed or Refractory Acute B-Lymphoblastic Leukemia: Prognostic Impact on Patients With Early CAR-T Cell Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: peripheral blood lymphocytes, CIK cell.
- Who it may be relevant to
- Registry conditions: B-cell Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, in Relapse, Refractory Acute Lymphoid Leukemia. Basic parameters: 1 year — 39 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cytokine-induced Killer(CIK) Cell Therapy and Its Impact on Early Functional Exhaustion of Chimeric Antigen Receptor-T(CAR-T) Cells in Relapsed or Refractory Acute B-Lymphoblastic Leukemia: A Prospective Study
Overview
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.
Interventions
- Drug peripheral blood lymphocytes
autologous or allogeneic peripheral blood lymphocytes - Drug CIK cell
autologous or allogeneic cytokine-induced killer (CIK) cells
Primary outcome measures
- Event-free survival(EFS) in CIK infusion group [Time frame: 2-year EFS rate]
Secondary outcome measures (4)
- Progression-free survival(PFS) in CIK infusion group [Time frame: 2-year PFS rate]
- Duration of response(DOR) in CIK infusion group [Time frame: from enrollment to the end of treatment at 15 years]
- Overall survival(OS) in CIK infusion group [Time frame: from enrollment to the end of treatment at 15 years]
- EFS in mRNA-CIK infusion group [Time frame: 2-year EFS rate]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing GoBroad Hospital — Beijing
Identifiers
NCT: NCT06389305 · BJGBYY-IIT-LCYJ-2024-012