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Brief Title: Anti-CD19 Allo-CAR-T Cells for Relapsed B Cell Malignancies After HSCT
Official Title: Anti-CD19 Donor-derived CAR-T Cells for Patients With Relapsed B Cell Malignancies After Hematopoietic Stem Cell Transplantation: a Multi-center, Uncontrolled Trial.
Study ID: NCT04516551
Brief Summary: The patients with relapsed B cell acute lymphoblastic leukemia (ALL) after hematopoietic stem cell transplant (HSCT) have a poor prognosis, especially for these relapsed in a short time after transplantation. Nowadays there is no effective way to salvage patients in such conditions. T cells derived from healthy matched sibling or unrelated donors have not been restrained by tumor micro-environment and retain anti-leukemia ability, which makes it serve well for patients with relapsed B-ALL. So we launched a multi-center clinical trial to proved the safety and efficacy of anti-CD19 CAR-T cells for relapsed B cell ALL.
Detailed Description: The stunning response rate of anti-CD19(cluster of differentiation antigen 19) auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or refractory B-cell hematologic malignancies. However, for B-ALL patients suffered from relapse after allo-HSCT (hematopoietic stem cell transplant), the T cells derived from healthy donor seems like a better origin for CAR-T cells producing because T cells derived from healthy matched sibling or unrelated donors have not been restrained by tumor micro-environment and retain anti-leukemia ability. So after we designed a clinical trial to manifest the safety and efficacy of anti-CD19 CAR-T cells for patients with relapsed B cell ALL.
Minimum Age: 14 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Department of Hematology, Xinqiao Hospital, Chongqing, Chongqing, China
Name: Xi Zhang, MD phD
Affiliation: Xinqiao Hospital of Chongqing
Role: STUDY_CHAIR
Name: He Huang, MD
Affiliation: First Affiliated Hospital of Zhejiang University
Role: PRINCIPAL_INVESTIGATOR