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Trial Title:
CD19-targeted CAR T Cell Autotransfusion for the Treatment of Recurrent/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children With CD19+
NCT ID:
NCT06355739
Condition:
B Lymphocytic Leukemia
B Lymphoblastic Lymphoma
Conditions: Official terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
CAR T cell injection
Description:
intravenous injection
Arm group label:
CD19 autotransfusion for B-cell acute lymphoblastic leukemia in children
Summary:
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
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
3 Years
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaofan Zhu, MD
Phone:
86-21-23909001
Email:
xfzhu@ihcams.ac.cn
Investigator:
Last name:
Jingliao Zhang, MD
Email:
Sub-Investigator
Facility:
Name:
InstituteHBDH
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhu Xiaofan
Phone:
86-21-23909001
Email:
xfzhu@ihcams.ac.cn
Investigator:
Last name:
Guo Ye
Email:
Principal Investigator
Investigator:
Last name:
Yang Wenyu
Email:
Principal Investigator
Investigator:
Last name:
Chen Xiaojuan
Email:
Principal Investigator
Investigator:
Last name:
Chen Yumei
Email:
Principal Investigator
Investigator:
Last name:
Ruan Min
Email:
Principal Investigator
Start date:
February 1, 2024
Completion date:
January 15, 2027
Lead sponsor:
Agency:
Zhu Xiaofan
Agency class:
Other
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06355739
