Actively Recruiting
Phase II Study of CD19-Targeted CAR T Cell Autotransfusion (BIC-19GG, BIC-2019, BIC-2219) for Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma in Children
Led by Zhu Xiaofan · Updated on 2024-04-09
60
Participants Needed
2
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of three autotransfusion agents targeting CD19 chimeric antigen receptor T lymphocytes (BIC-19GG, BIC-2019, BIC-2219) for treating children aged 3 to 18 years with relapsed or refractory B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma that express CD19. This trial aims to understand how these treatments affect overall survival and event-free survival in this patient group. The study involves intravenous injections of CAR T cells designed to target CD19 on cancer cells. Participants receive one of the three investigational CAR T cell therapies. The treatment focuses on children with specific markers and disease characteristics who have not responded to previous standard chemotherapy or relapsed after bone marrow transplantation. During the study, children will be closely monitored for overall survival and event-free survival over 24 months after infusion. Researchers will also assess remission rates one month after treatment and track any adverse events for up to 12 months. Participants will undergo clinical evaluations, including tests of liver, kidney, heart, and lung function, as well as blood tests and antigen tests. The total duration of involvement covers at least two years post-treatment for outcome assessment.
CONDITIONS
Brief 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
- Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma
- Disease status includes marrow response not achieved after at least 2 chemotherapy courses, molecular level incomplete response, or recurrence during or after chemotherapy
- Lansky performance score of 60 or higher
- Positive test for treatment-related antigens (CD19, CD20, or CD22)
- Expected survival longer than 3 months
- Hemoglobin level 70 g/L or higher (with blood transfusion if needed)
- Liver, kidney, heart, and lung function meeting specified limits including creatinine ≤1.5 times ULN, left ventricular ejection fraction ≥50%, blood oxygen saturation >90%, total bilirubin ≤1.5 times ULN, ALT and AST ≤2.5 times ULN
You will not qualify if you...
- Severe heart failure with left ventricular ejection fraction less than 50%
- History of severe lung function impairment
- Presence of other advanced malignant tumors
- Serious infections that cannot be effectively controlled
- Serious autoimmune disease or congenital immune deficiency
- Active hepatitis B or C infection
- 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 following allogeneic stem cell transplantation
- Other serious physical or mental illnesses or abnormal lab tests increasing risk or interfering with study results
- Investigator judgment of unsuitability for participation
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 - Single administration
Participants receive a CD19-targeted CAR T cell intravenous injection as treatment for relapsed or refractory B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma.
1 treatment visit (in-person)
Duration - Up to 24 months post-infusion
Participants are monitored for overall survival, event-free survival, remission rate, and adverse events following the CAR T cell infusion.
Regular follow-up visits over 24 months
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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