Actively Recruiting
Clinical Trial of CD19 and CD22 CAR T-cell Sequential Therapy Versus Single CD19 CAR T-cell Bridging to Transplantation for Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Patients
Led by Beijing GoBroad Hospital · Updated on 2026-03-10
353
Participants Needed
1
Research Sites
43 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
Researchers are evaluating treatments for children, adolescents, and young adults with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL). This non-randomized, open-label trial compares the effectiveness of two treatment approaches: sequential infusions of CD19 and CD22 CAR T cells versus CD19 CAR T cell infusion followed by hematopoietic stem cell transplantation (HSCT). The goal is to understand which approach offers better event-free survival for patients aged 1 to 70 years with this condition. Participants may choose between three groups: sequential treatment with CD19 and CD22 CAR T cells, CD19 CAR T cell infusion followed by HSCT, or CD19 CAR T cell infusion alone without additional consolidation therapy. The study will monitor the treatments over time, including the levels of CAR T cells in the body and the presence of leukemia cells. Treatments involve infusions of genetically modified immune cells designed to target cancer cells and, for some, a transplant procedure to replace bone marrow. During the trial, participants will undergo regular assessments including laboratory tests to measure leukemia response, monitoring of CAR T cell levels, and evaluation of side effects. The main outcome measured is event-free survival over two years, with additional long-term follow-up up to 15 years to observe overall survival, duration of response, and safety. Participants will be closely monitored throughout the treatment and follow-up periods to collect this information.
CONDITIONS
Brief 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 meeting NCCN guidelines
- Age between 1 and 70 years old
- No serious allergic constitution
- Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 2
- Life expectancy of at least 60 days as judged by the investigator
- Signed voluntary informed consent by patients aged 8-70 years or legal guardians for patients under 18 years
You will not qualify if you...
- Intracranial hypertension or unconscious state
- Acute heart failure or severe arrhythmia
- Acute respiratory failure
- Presence of other malignant tumors
- Diffuse intravascular coagulation
- Serum creatinine or blood urea nitrogen over 1.5 times the normal value
- Sepsis or uncontrolled infection
- Uncontrolled diabetes mellitus
- Severe psychological disorder
- Cranial lesions detected 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
- Active, uncontrolled infection including hepatitis B, hepatitis 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 - Up to 15 years from enrollment
Participants receive CD19 and CD22 CAR T-cell sequential therapy or CD19 CAR T-cell treatment followed by hematopoietic stem-cell transplantation (HSCT).
Visit schedule varies depending on treatment arm and clinical 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
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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