CD19 CAR T-cell Target Relapsed/Refractory Acute B Cell Leukemia/Lymphoma (NCT05613348) | Clinical Trial Compass
WithdrawnPhase 1/2
CD19 CAR T-cell Target Relapsed/Refractory Acute B Cell Leukemia/Lymphoma
Stopped: The company failed to provide corresponding CART services.
China0Started 2022-12-01
Plain-language summary
This study aims to evaluate the safety and efficacy of humanized Anti-CD19 Chimeric Antigen Receptor-T cell (CAR19T2 T cell) in children with refractory/relapsed B-cell acute lymphoblastic leukemia/lymphoma.
Who can participate
Age range1 Year β 18 Years
SexALL
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Inclusion criteria
β. β₯1 year old and β€18 years.
β. Patients with relapsed and/or refractory CD19-positive B-cell acute leukemia/lymphoma.
β. Leukemia/lymphoma relapsed after allogeneic hematopoietic stem cell transplantation within four weeks, all immunosuppressive agents were stopped for at least four weeks, and no active graft-versus-host disease(GVHD) was detonated.
β. Lansky play (β€16 years old) scale β₯60% or Karnofsky (\>16 years old) score β₯60% and Eastern Cooperative Oncology Group (ECOG) performance status β€1. Patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory to assess the performance score.
β. Adequate vascular access leukapheresis procedure. Absolute Lymphocyte count (ALC) greater than or equal to 100 cells/ΞΌL.
β. Adequate renal, hepatic, pulmonary, and cardiac function is defined as the following:
β. Life expectancy of greater than or equal to 3 months.
β. Patients or legal guardians must sign an informed consent.
Exclusion criteria
β. Prior received any other CAR T cell and tumor vaccine treatment.
β. Patient with a previous history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
β. Patient with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment.
What they're measuring
1
Overall response rate
Timeframe: 3 months
2
The maximum tolerated dose(MTD) of CAR19T2 T cells
β. Acute GVHD grade II-IV (Glucksberg criteria) or chronic GVHD requiring systemic treatment within 4 weeks before enrollment.
β. History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, etc. (Except for CNS involvement of underlying hematological malignancy)
β. Severe psychological disorder or psychiatric illness.
β. Combined with life-threatening severe organ failure.
β. Major non-medicinal surgery within four weeks.