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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
The T cells collected from haploidentical donors have been manufactured to express CAR to binding CD19 on B-cell leukemia.
Department of Hematology, Xinqiao Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGthe safety of anti-CD19 allo CAR-T cells
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: within 4 weeks after infusion
the efficacy of anti-CD19 allo CAR-T cells
ratio of bone marrow blast cells
Time frame: 4 weeks after infusion
The long-term efficiency
ratio of bone marrow blast cells
Time frame: up to 2 years after infusion
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