Universal CAR-T Cells Targeting 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

Más betegség

• Uncontrolled active infection
• Active hepatitis B or hepatitis C infection
• Any uncontrolled active medical disorder that would preclude participation
• HIV infection

Egyéb

• Pregnant or lactating women

• 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