Actively Recruiting
CD19-targeted CAR T Cell Autotransfusion for the Treatment of Recurrent/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children With CD19+
Led by Zhu Xiaofan · Updated on 2024-04-09
60
Participants Needed
2
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and efficacy of BIC-19GG, BIC-2019, BIC-2219 in the treatment of relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoma in children
CONDITIONS
Official Title
CD19-targeted CAR T Cell Autotransfusion for the Treatment of Recurrent/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children With CD19+
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 3 and 18 years old, male or female
- Clinically diagnosed relapsed or refractory B acute lymphoblastic leukemia or lymphoblastic lymphoma
- Patients with complete marrow response (MRD >1%) or no response after at least 2 chemotherapy induction courses
- Patients with molecular and immunologic complete response who did not turn negative after treatment
- Recurrence during chemotherapy, early recurrence within 12 months after drug withdrawal, or late recurrence after 12 months without complete remission after one standard induction course
- Recurrence after bone marrow transplantation
- Presence of simple bone marrow, extramedullary (testicular or central nervous system leukemia), or combined relapse
- Lansky score 60 or higher
- Positive for treatment-related antigens (CD19/CD20/CD22)
- Expected survival of more than 3 months from signing informed consent
- Hemoglobin level 70 g/L or higher (with blood transfusion if needed)
- Liver, kidney, and cardiopulmonary function meeting specified limits: creatinine ≤1.5× ULN; left ventricular ejection fraction ≥50%; blood oxygen saturation >90%; total bilirubin ≤1.5× ULN; ALT and AST ≤2.5× ULN
You will not qualify if you...
- Severe cardiac insufficiency with left ventricular ejection fraction under 50%
- History of severe lung function impairment
- Presence of other advanced malignant tumors
- Serious uncontrolled infections
- Serious autoimmune disease or congenital immune deficiency
- Active hepatitis with positive HBV DNA or HCV RNA
- HIV infection, AIDS, or syphilis infection
- History of severe allergy to biological products including antibiotics
- Acute graft-versus-host disease one month after stopping immunosuppressants post allogeneic stem cell transplant
- Other serious physical or mental illnesses or laboratory abnormalities increasing study risk or interfering with results
- Investigator's judgement deeming the patient unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
2
InstituteHBDH
Tianjin, Tianjin Municipality, China, 300020
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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