Actively Recruiting
CIK Cell Therapy for Relapsed or Refractory Acute B-Lymphoblastic Leukemia: Prognostic Impact on Patients With Early CAR-T Cell Dysfunction
Led by Beijing GoBroad Hospital · Updated on 2026-02-25
213
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
CIK Cell Therapy for Relapsed or Refractory Acute B-Lymphoblastic Leukemia: Prognostic Impact on Patients With Early CAR-T Cell Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of refractory or relapsed B-ALL according to NCCN guidelines
- Loss of CAR-T cell activity within 6 months after previous CAR-T therapy without 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 of at least 60 days as judged by the investigator
- Informed consent signed by patients aged 8 to 39 years or legal guardians for children under 18 years
You will not qualify if you...
- Received bendamustine treatment within the past 9 months
- Intracranial hypertension or impaired consciousness
- Symptomatic heart failure or severe arrhythmia
- Symptoms of severe respiratory failure
- Presence of other malignant tumors
- Disseminated intravascular coagulation
- Serum creatinine and/or blood urea nitrogen levels 1.5 times or more above normal
- Suffering from sepsis or other uncontrollable infections
- Uncontrollable diabetes
- Severe mental disorders
- Significant brain lesions detected by MRI
- Leukemic cells in cerebrospinal fluid more than 20 cells/μL
- Peripheral blood leukemic cell proportion over 30%
- Previous organ transplantation
- Pregnant or lactating females with childbearing potential
- Active or uncontrollable infectious diseases such as hepatitis (HBV, HCV), HIV, or syphilis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102206
Actively Recruiting
Research Team
T
Tengyu Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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