Determining Safety and Maximum Tolerated Dose (MTD) of Anti-BCMA CAR-NK Therapy in Relapsed or Refractory Multiple Myeloma

Tehran University of Medical Sciences0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年5月27日

适应症

试验速览

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•1.Age 18-80 years with expected survival > 3 months.
•2.Confirmed diagnosis of active multiple myeloma with detectable BCMA expression in malignant cells.
•3.Relapsed or refractory disease with at least 2 prior lines of treatment, including a proteasome inhibitor and immunomodulator, without achieving significant efficacy.
•4.Measurable disease at screening according to IMWG criteria, as defined by any of the following: Serum monoclonal paraprotein (M-protein) level =1.0 g/dL or urine M-protein level being as defined; or light chain MM without measurable disease in the serum or the urine; serum immunoglobulin free light chain disease dL and abnormal serum immunoglobulin kappa/lambda free light chain ratio.
•5.ECOG performance status of 0-1.
•6.Acceptable cardiac, liver, and kidney function.
•7.Signed written informed consent.

•1.Pregnant or lactating women.
•2.Uncontrolled active infection, HIV infection, or positive syphilis serology reaction.
•3.Active hepatitis B or hepatitis C infection.
•4.Recent or current use of glucocorticoids or other immunosuppresses.
•5.Severe cardiac, liver, renal insufficiency, diabetes, or other diseases.
•6.Participation in other clinical research in the past three months.

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