Universal CAR-T Cells for the Treatment of Multiple Myeloma
The aim of this study is to assess the feasibility, safety and efficacy of universal CAR T cells targeting multiple myeloma. Another goal of the study is to learn more about the persistence and function of the universal CAR T cells in the body.
• Patients with confirmed multiple myeloma failed curative treatment options (including autologous or allogeneic SCT).
• Complete remission (CR) cannot be achieved after at least 2 prior therapy regimens.
• High risk MM in CR1 or CR2 and not eligible for SCT because of age or comorbid diseases.
• Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year).
• Relapsed after prior autologous or allogenic SCT with residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.
• Residual disease after primary therapy and not eligible for ASCT
• Expected survival \> 12 weeks• Creatinine \< 2.5 mg/dl• ALT (alanine aminotransferase)/AST (aspartate aminotransferase) \< 3x normal
• Bilirubin \< 2.0 mg/dl
• Any relapse after prior SCT is eligible regardless of other prior therapy
⁃ Adequate venous access for apheresis, and no other contraindications for leukapheresis
⁃ Voluntary informed consent is signed