Long-term Follow-up Study in Subjects With Multiple Myeloma Previously Treated With GC012F Injection

This is an open-label, multicenter, observational study (non-interventional study) to evaluate the long-term safety, efficacy, and in vivo pharmacokinetic persistence of CAR-T cells in subjects treated with GC012F Injection. The study population consists of patients with multiple myeloma who previously received GC012F Injection in an investigator-initiated trial. Subjects enrolled in this study must have completed the efficacy and safety follow-up of the main study or withdrawn early from the main study.

No additional study drug will be administered in this study (i.e., no further use of the study drug). If the main study in which the subject previously participated allowed lenalidomide maintenance therapy after GC012F Injection treatment, the subject may continue to receive lenalidomide maintenance therapy after being enrolled in this study, which will not be counted as receiving another antitumor therapy. For 15 years from the time the subject received GC012F Injection infusion, data, including specific adverse events (AEs) [including new malignancies, new onset of grade ≥3 infections, new onset or worsening of pre-existing neurological disorders, new onset or worsening of pre-existing rheumatism/other autoimmune diseases, and new onset of grade ≥3 hematologic toxicity related to GC012F Injection], AEs related to GC012F Injection, overall survival (OS), progression-free survival (PFS), duration of response (DOR), objective response rate (ORR), replication-competent lentivirus (RCL), and CAR gene insertion site testing, will be collected to evaluate the long-term safety, tolerability, efficacy, and in vivo pharmacokinetic persistence of CAR-T cells.

Inclusion criteria

• Patients with multiple myeloma who previously received GC012F Injection infusion in an investigator-initiated trial;
• Patients who have completed the safety and efficacy follow-up of the main study or withdrawn early;
• Patients who agree to sign the informed consent form and are willing and able to comply with the visits, laboratory tests, and other protocol requirements specified in the study visit schedule;

Exclusion criteria

• Patients with multiple myeloma who participated in the main study but withdrew early without receiving GC012F Injection;
• Patients who refuse to undergo long-term follow-up after GC012F Injection treatment;