A Phase I Study of CD19 Specific Chimeric Antigen Receptor T-cells for Therapy of Persistent and Relapsed B-cell Leukaemia and Lymphoma Post Allogeneic Stem Cell Transplantation

Western Sydney Local Health District, Westmead Hospital0 个研究点目标入组 20 人开始时间: 2017年11月27日最近更新: 2018年11月12日

试验速览

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•1. Any patient regardless of sex or age with persistent or recurrent disease after a matched related allogeneic stem cell transplant performed for CD19+ lymphoid malignancies. Disease may be identified by clinical examination, radiology, nuclear imaging, flow cytometry or molecular biological methods.
•2. Life expectancy greater than or equal to 6 weeks.
•3. Karnofsky/Lansky score greater than or equal to 50%, or ECOG less than or equal to 2.
•4. Donor willing and available to donate peripheral blood for the generation of CAR19 T-cells.
•5. Sexually active patients must be willing to utilise one of the more effective birth control methods for 6 months after the CTL infusion. Male partners should use a condom.
•6. Donor and patient and/or parent/guardian capable of providing informed consent.

•1. Uncontrolled inter-current infection.
•2. Graft versus host disease greater than or equal to grade II.
•3. Unmanipulated donor lymphocyte infusion within the previous 10 weeks.
•4. Corticosteroid dose greater than the equivalent of 0.5mg/kg of oral prednisolone.
•5. Bilirubin >2x upper limit of normal, AST >3x upper limit of normal, creatinine >2x upper limit of normal for age.
•6. Pulse oximetry less than or equal to 90% on room air.
•7. Pregnant or lactating.
•8. History of hypersensitivity reactions to murine protein-containing products.
•9. History of seizures.

发起方

Western Sydney Local Health District, Westmead Hospital