Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants With Relapsed or Refractory AL Amyloidosis

Prior treatment

• Cardiac exclusion criteria:
  • Mayo Stage IIIb AL amyloidosis as defined by
  • \- NT-proBNP\>8500ng/L, and
  • high sensitivity cardiac troponin T ≥ 50 ng/L cardiac Troponin T ≥ 0.035 ng/mL or cardiac Troponin I ≥ 0.1 ng/mL
  • NT-proBNP levels as follows:
  • \- NT-proBNP ≥ 2000 ng/L (for dose escalation portion)
  • NT-proBNP \< 2000 and \> 8500 ng/L (for dose extension portion)
  • NYHA class III or IV
  • 5\. Extensive GI involvement with evidence of active GI bleeding/risk of bleeding as determined by Investigator 6. Prior therapies:
• CAR T cell therapy directed at any target
• Prior BCMA-targeting therapy
• Prior treatment with any approved or investigational T cell engaging therapies (including T cell-directed bispecific or trispecific therapies) at any target within the last 6 months.
  • 7\. Toxicity from previous anti-cancer or anti-PC-directed therapy did not resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
  • 8\. Active plasma cell leukemia at the time of screening 9. Multiple myeloma defined as clonal bone marrow PCs ≥10% and any one or more of the following myeloma defining events (deemed as attributable to multiple myeloma by Investigator) 10. Seropositive for HIV 11. Serologic status reflecting active hepatitis B or C:

Other illness

• Patients with positive core antibody (anti-HBc) and HBV-DNA positive.
• Patients with positive hepatitis C antibody and HCV RNA positive.

Other

• Have any other form of amyloidosis other than AL amyloidosis
• Mayo Stage IIIb AL amyloidosis
• Oxygen saturation \< 95% on room air
• Systolic blood pressure \<100mmHg
• Positive HBsAg, or

• 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.