Actively Recruiting
Cytokine-induced Killer (CIK) Cell Therapy and Its Impact on Early Functional Exhaustion of CAR-T Cells in Relapsed or Refractory Acute B-Lymphoblastic Leukemia: A Prospective Study
Led by Beijing GoBroad Hospital · Updated on 2026-02-25
213
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating cytokine-induced killer (CIK) cell therapy in children and young adults aged 1 to 39 years with relapsed or refractory acute B-lymphoblastic leukemia (r/r B-ALL) who experience early exhaustion of CAR-T cells. This randomized, double-blind trial aims to determine how CIK cell therapy impacts the prognosis of patients facing early functional decline of CAR-T cells, focusing on event-free survival as the primary outcome. Participants will be randomly assigned to one of three groups: a control group receiving peripheral blood lymphocytes, a group receiving CIK cell therapy, and a group receiving messenger RNA-modified CIK cell therapy. The study plans to enroll 213 subjects and will compare outcomes such as event-free survival, progression-free survival, duration of response, and overall survival over periods extending up to 15 years. During the study, patients will be closely monitored for their response to the therapies and for any treatment-related events. Measurements include the 2-year event-free survival rate as the primary endpoint, along with secondary outcomes like progression-free survival and overall survival. The trial involves regular assessments to track disease status and therapy effects, with a total participation duration that may extend up to 15 years for long-term follow-up.
CONDITIONS
Brief 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-cell acute lymphoblastic leukemia 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
- ECOG performance status score of 0 to 2
- Life expectancy of at least 60 days as judged by the investigator
- Signed informed consent by patient or legal guardian for those under 18 years old
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
- Severe respiratory failure symptoms
- Presence of other types of malignant tumors
- Disseminated intravascular coagulation
- Serum creatinine or blood urea nitrogen at least 1.5 times normal
- Uncontrolled infections such as sepsis
- Uncontrollable diabetes
- Severe mental disorders
- Significant brain lesions detected by MRI
- Leukemic cells in cerebrospinal fluid over 20 cells/µL
- Peripheral blood leukemic cell proportion over 30%
- Previous organ transplantation
- Pregnant or lactating females of childbearing potential
- Active or uncontrollable infections including hepatitis B or C, HIV, or syphilis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment to the end of treatment up to 15 years
Participants receive either autologous or allogeneic peripheral blood lymphocytes or cytokine-induced killer (CIK) cells as treatment for relapsed or refractory acute B-lymphoblastic leukemia.
Visit frequency is based on treatment protocol
Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102206
Actively Recruiting
Research Team
T
Tengyu Wang
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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