A Phase 1b Study of GC012F, a Chimeric Antigen Receptor T Cell Therapy Targeting CD19 and B-cell Maturation Antigen in Chinese Participants With Relapsed or Refractory AL Amyloidosis
This is a Phase 1b open-label, multicenter, non-randomized study of GC012F, a CD19/BCMA dual CAR T cell therapy, in adult participants with relapsed/refractory AL amyloidosis.
• Confirmed histopathological diagnosis of AL amyloidosis
• One or more organs currently or historically impacted by AL amyloidosis according to consensus guidelines
• Measurable hematologic disease: dFLC \> 20 mg/L or serum M-protein \> 5g/L
• Relapsed disease or refractory disease defined as a need for additional therapy after at least 1 line of anti-plasma cell-directed therapy.
• ECOG performance status of 0 to 1
• Must be able and willing to adhere to the study visit schedule and other protocol requirements
• Women of child-bearing potential (WCBP) must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study.