Phase I Clinical Trial of Anti-BCMA CAR5 T Cells in Thai Patients with Relapsed/Refractory Multiple Myeloma

Mahidol University0 个研究点目标入组 24 人开始时间: 2024年5月27日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1.Male or female, Age 18 to 70 years old
•2.ECOG less than or equal 2 and the excepted survival more than or equal 3 months
•3.Subjects must have been diagnosed as relapsed and or refractory multiple myeloma with all of
•3.1Treated with at least two lines of therapy
•3.2There were no assessable novel agents including bortezomib, thalidomide, lenalidomide, pomalidomide, carfilzomib, or daratumumab.
•3.3Disease must have either progressed after the last regimen or presented failure to achieve at least partial remission with the last regimen.
•4.The main organs function is good;
•4.1liver function such as ALT or AST less than 3 times normal value upper limit (ULN) and total bilirubin less than 34.2 mol per L
•4.2renal function: creatinine less than 220 mu/L, GFR more than 30 mL/min
•4.3lung function such as blood oxygen saturation is greater than 95%
•4.4cardiac function such as left ventricular ejection fraction (LVEF) is greater than 50%
•5.Platelets more than 40 billion/L
•6.Patients without any anti-cancer treatment such as chemotherapy, radiotherapy, immunotherapy (immunosuppressive drugs) within 2-4 weeks before, and the treatment-related toxicity reaction less than or equal 1 level prior to enrollment (except low toxicity lose hair for example)
•7.Venous channel is unobstructed, which can meet the needs of intravenous drip
•8.Voluntary informed consent is given, agree to follow the trial treatment and visit plan

•1.Patients with allergy to large molecules such as antibodies or cytokines
•2.More than 5mg of hormones (except patients with inhaled hormone) were used within 2 to 4 weeks prior enrollment
•3.Patients with severe autoimmune diseases or immunodeficiency diseases
•4.Patients treated with other immune cellular products (DC, CIK, T, NK, and CART products with CD19 or other targets)
•5.Patients with uncontrollable infectious disease in the first 4 weeks of treatment
•6.Active hepatitis B DNA more than 1000 copy/mL , hepatitis C positive, (HCV positive resistance, HCV RNA positive)
•7.Patients participated in other clinical trials within 6 weeks prior enrollment
•8.Patients with mental illness
•9.Patients with drug abuse or addiction and medical, psychological or social conditions may interfere with the study or evaluate the results of the study
•10.Patients have alcohol dependence
•11.Pregnant or lactating women, Men or women who have a pregnancy plan within a year, The patients cannot guarantee effective contraceptive measures during the trial period
•12.Patients had other conditions that were not appropriate for the group determined by the researchers

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