CD8 PET imaging study before and after CAR T-cell therapy

MCG0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•1. Subjects with histologically confirmed LBCL and subtypes according to the WHO 2016 criteria
•2. who fulfill the eligibility criteria for anti-CD19 CAR T-cell therapy according the Immune Effector Cell Working Group Tumorboard.
•3. Tumor lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
•4. Measurable disease, as defined by Lugano criteria.
•5. Signed informed consent.
•6. Age =18 at the time of signing informed consent.
•7. Life expectancy =12 weeks.
•8. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
•9. Ability to comply with the protocol.
•10. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate [< 1% per year] when used consistently and correctly).

•1. Signs or symptoms of active infection within 2 weeks prior to ZED88082A/CED88004S injection, unless treated to resolution.
•2. Prior CD19-directed CAR T-cell therapy or other bi-specific antibodies targeting CD19 receptor (e.g. blinatumomab).
•3. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
•4. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ZED88082A/CED88004S, or that may affect the interpretation of the results or render the patient at high risk from complications.
•5. Pregnant or lactating women.
•6. HIV-positive patients

发起方

MCG