CD19-targeted CAR T Cell Autotransfusion for the Treatment of Recurrent/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children With CD19+
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
Eligibility
Sex
ALL
Min age
3 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
1, age 3-18 years old (including boundary value), male and female;
2\. The patient was clinically diagnosed as relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoblastic
Patients with tumors who meet one of the following conditions:
• Complete marrow response (MRD\>1%) or not achieved after at least 2 courses of standardized induction regimen chemotherapy
Complete response at the molecular level and immunology (characterized by specific molecular markers and immunophenotypes prior to treatment)
Patients, did not turn negative after treatment);
* Recurrence during chemotherapy, early recurrence after drug withdrawal (\<12 months) or late recurrence after complete remission (≥
12 months) and did not achieve complete remission after 1 course of standard induction regimen (MRD\>1%);
* Recurrence after bone marrow transplantation;
* Simple bone marrow, simple extramedullary (testicular leukemia, central nervous system leukemia) or combined
recrudescence
3\. Lansky score ≥60;
4, the treatment related antigen test result is positive (CD19/CD20/CD22);
5\. The expected survival period from the signing date of the informed consent is more than 3 months;
6, HGB≥70g/L (blood transfusion);
7, liver and kidney function, cardiopulmonary function meet the following requirements:
1. Creatinine ≤1.5×ULN;
2. Left ventricular ejection fraction ≥50%;
3. Blood oxygen saturation \>90%;
4. Total bilirubin ≤1.5×ULN; ALT and AST≤2.5 x ULN.-
Exclusion Criteria:
* 1, severe cardiac insufficiency, left ventricular ejection fraction \<50%;
2, have a history of severe lung function impairment;
3\. Combined with other advanced malignant tumors;
4, combined with serious infection and can not be effectively controlled;
5, combined with serious autoimmune disease or congenital immune deficiency;
6, active hepatitis (hepatitis B virus deoxyribonucleic acid \[HBVDNA\] or hepatitis C virus ribonucleic acid \[HCVRNA\] positive);
7, human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
8\. Have a history of severe allergy to biological products (including antibiotics);
9\. Patients with allogeneic hematopoietic stem cell transplantation still had acute graft-versus-host response (GvHD) one month after immunosuppressant discontinuation;
10, the presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participating in the study or interfere with the study results, as well as patients deemed unsuitable for participation in the study by the investigator.
Primary outcome measure(s)
Overall survival and event-free survival — 24 months post CAR-T cell infusion The prognosis of ALL children who underwent CAR-T cell therapy
Trial sites (2)
Facility
City
Region
Status
Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
Tianjin
Tianjin Municipality
Recruiting
InstituteHBDH
Tianjin
Tianjin Municipality
Not Yet Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.