Actively Recruiting
Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r/r B-ALL Patients
Led by Beijing GoBroad Hospital · Updated on 2026-03-10
353
Participants Needed
1
Research Sites
1015 weeks
Total Duration
On this page
Sponsors
B
Beijing GoBroad Hospital
Lead Sponsor
T
The General Hospital of Western Theater Command
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multi-center, open-label, non-randomized, two-arm, non-inferior trial. Patients with r/r B-ALL would be assigned to the CD19 CAR and CD22 CAR T-cell sequential infusion group (Sequential CAR, Arm-1) and the CD19 CAR T-cell infusion bridging to hematopoietic stem cell transplantation group (CAR+HSCT, Arm-2), according their own discretion. Patients would be also allowed to assigned to the CD19 CAR T-cell infusion without consolidation therapies group (Single CAR, additional placebo arm) according their own discretion. The primary objective is to prospectively evaluate and compare the efficacy of CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT in the treatment of r/r B-ALL. The primary endpoint is event-free survival of children and adolescent and young adult (AYA) with r/r B-ALL a treated with CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT. A total number of 353 subjects will be enrolled.
CONDITIONS
Official Title
Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r/r B-ALL Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary refractory or relapsed B-cell Acute Lymphoblastic Leukemia
- Positive CD19 and CD22 expression on leukemia cells (>80%)
- Aged between 1 and 70 years
- No serious allergic conditions
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Life expectancy of at least 60 days as judged by the investigator
- Signed informed consent by patients aged 8-70 or legal guardians for patients under 18
You will not qualify if you...
- Presence of intracranial hypertension or unconsciousness
- Acute heart failure or severe arrhythmia
- Acute respiratory failure
- Having other types of malignant tumors
- Diffuse intravascular coagulation
- Serum creatinine or blood urea nitrogen levels over 1.5 times the normal value
- Sepsis or other uncontrolled infections
- Uncontrolled diabetes mellitus
- Severe psychological disorders
- Cranial lesions visible by MRI
- More than 20 leukemic cells/µL in cerebrospinal fluid
- More than 30% leukemic cells in peripheral blood
- Organ transplant recipients
- Pregnant or breastfeeding women
- Active, uncontrolled infections including hepatitis B, hepatitis C, HIV, or syphilis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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