A Phase 1b/2 Study of AZD0120 (Also Known as GC012F), a Chimeric Antigen Receptor T Cell Therapy Targeting CD19 and B Cell Maturation Antigen in Participants With Relapsed or Refractory AL Amyloidosis.
Open-label Phase 1b/2 study with primary objective of this study is to evaluate the safety, tolerability and efficacy of AZD0120 in participants with light chain (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.