A Phase 1 interventional study of anti-CD19 allo-CAR-T cells in Relapsed Adult ALL and B Cell Leukemia, sponsored by Xinqiao Hospital of Chongqing. Status unknown at 1 site in China. Open to participants aged 14 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-11-17.
Sponsored by Xinqiao Hospital of Chongqing · Phase 1, Interventional, and Treatment
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.
126 studies on the registry are indexed under Leukemia, B-Cell; 46 are open to participants now.
This study's planned enrollment of 18 is below the median of 40 across 110 interventional studies indexed under Leukemia, B-Cell.
Browse Leukemia, B-Cell studies →Xinqiao Hospital of Chongqing is the lead sponsor of 68 studies on the registry; 21 are open to participants now.
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The study will employ dose level cohorts of three patients that will be treated at each level described below, based on the number of T cells to be infused using the "3 + 3" dose-escalation strategy to find MTD followed by a dose-expansion phase at determining optimal dosage. dosage: the number of anti CD19+CD22 CAR T cells -1(if needed) 1×10\^6/KG 3×10\^6 /KG 6×10\^6 /KG 1×10\^7/KG Treatment follows a lymphodepletion, chemotherapy regimen that consists of Fludarabine (30 mg/m2 per day) and Cyclophosphamide (300mg/m2 per day) for 3 days or bendamustione (90mg/m2 per day) for two days prior to cell infusion.
Biological: anti-CD19 allo-CAR-T cells
The T cells collected from haploidentical donors have been manufactured to express CAR to binding CD19 on B-cell leukemia.
the 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
Plan to share: No
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Xinqiao Hospital of Chongqing