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

Exclusion Criteria

• •1. Have any other form of amyloidosis other than AL amyloidosis
• •2. Mayo Stage IIIb AL amyloidosis
• •3. Oxygen saturation \< 95% on room air
• •4. Systolic blood pressure \<100mmHg
• •1. Mayo Stage IIIb AL amyloidosis (Wechalekar, 2013)
• •2. NT-proBNP levels as follows:
• •NT-proBNP ≥ 2000 ng/L (for dose escalation portion) NT-proBNP \< 2000 and \> 5000 ng/L (for dose extension portion) c. High-sensitivity cardiac troponin T \> 75 ng/L d. 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:
• •1. CAR T cell therapy directed at any target
• •2. Prior BCMA-targeting therapy
• •3. 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) (Rajkumar, 2014) 10. Seropositive for HIV 11. Serologic status reflecting active hepatitis B or C:
• •1. Positive HBsAg, or
• •2. Patients with positive core antibody (anti-HBc) and HBV-DNA positive.
• •3. Patients with positive hepatitis C antibody and HCV RNA positive.