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Trial Title:
CIK Cell Therapy for Relapsed or Refractory Acute B-Lymphoblastic Leukemia: Prognostic Impact on Patients With Early CAR-T Cell Dysfunction
NCT ID:
NCT06389305
Condition:
B-cell Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, in Relapse
Refractory Acute Lymphoid Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
a prospective cohort study
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
peripheral blood lymphocytes
Description:
autologous or allogeneic peripheral blood lymphocytes
Arm group label:
peripheral blood lymphocytes
Intervention type:
Drug
Intervention name:
CIK cell
Description:
autologous or allogeneic cytokine-induced killer (CIK) cells
Arm group label:
CIK cells
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.
Criteria for 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.
Gender:
All
Minimum age:
1 Year
Maximum age:
39 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing GoBroad Hospital
Address:
City:
Beijing
Zip:
102206
Country:
China
Contact:
Last name:
Tengyu Wang
Phone:
86+18333186020
Email:
tengyu.wang@gohealtharo.com
Start date:
June 1, 2024
Completion date:
May 30, 2026
Lead sponsor:
Agency:
Beijing GoBroad Hospital
Agency class:
Other
Source:
Beijing GoBroad Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06389305
