Clinical Trial of CAR-T in the Treatment of Relapsed and Refractory Hematopoietic and Lymphoid Tissue Tumors in Children
NCT ID: NCT04610125
Last Updated: 2020-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-06-23
2025-06-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Auto CAR-T
Patients will be treated with Auto CAR-T cells
Auto CAR-T
Biological: Auto CAR-T
Cyclophosphamide,Fludarabine
Drug: Cyclophosphamide,Fludarabine
Leukapheresis
Leukapheresis
Interventions
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Auto CAR-T
Biological: Auto CAR-T
Cyclophosphamide,Fludarabine
Drug: Cyclophosphamide,Fludarabine
Leukapheresis
Leukapheresis
Eligibility Criteria
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Inclusion Criteria
2. Patients with relapsed and refractory hematopoiesis and lymphoid tissue tumors confirmed by clinical diagnosis;
3. Age: 1-18 years (including boundary value), both male and female;
4. Subjects with Lansky score ≥ 50;
5. The results of treatment-related antigens were positive;
6. The expected survival time is more than 3 months from the date of signing the informed consent.
Exclusion Criteria
2. He had a history of severe lung function damage;
3. Combined with other advanced malignant tumors;
4. Severe infection was found and could not be effectively controlled;
5. With metabolic diseases (except diabetes mellitus);
6. Combined with severe autoimmune disease or congenital immunodeficiency;
7. Untreated active hepatitis (hepatitis B, defined as positive HBsAg, HBV-DNA ≥ 500 IU / ml and abnormal liver function; hepatitis C, defined as hepatitis C antibody \[HCV AB\] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined with hepatitis B and hepatitis C co infection;
8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
9. Severe allergy history of biological products (including antibiotics);
10. Patients with acute graft-versus-host reaction (GVHD) after one month of discontinuation of immunosuppressants were still present;
11. The presence of other serious physical or mental illness or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and patients considered unsuitable for the study by the investigator.
1 Year
18 Years
ALL
No
Sponsors
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Hebei Medical University Fourth Hospital
OTHER
Hebei Senlang Biotechnology Inc., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Lian Jiang, MD
Role: PRINCIPAL_INVESTIGATOR
Hebei Medical University Fourth Hospital
Locations
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Pediatric hematology, Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China
Countries
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Central Contacts
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Facility Contacts
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Lian Jiang, MD
Role: primary
Other Identifiers
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Children CAR-T
Identifier Type: -
Identifier Source: org_study_id