Multi-CAR T Cell Therapy in the Treatment of Multiple Myeloma

Korábbi kezelés

• Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
• Previous related CAR-T cell therapy Any uncontrolled active medical disorder that would preclude participation

Más betegség

• Uncontrolled active infection
• Active hepatitis B or hepatitis C infection
• HIV infection

Egyéb

• Pregnant or lactating women

• Male and female subjects with surface antigen confirmed multiple myeloma with no available curative treatment options (including autologous or allogeneic SCT).
• Complete remission (CR) cannot be achieved after at least 4 prior combination therapy regimens.
• MM in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid diseases, or lack of available donor.
• 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 MM patients with relapsed or 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 given