An observational study in Multiple Myeloma, sponsored by RenJi Hospital. Enrolling by invitation at 1 site in China. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by RenJi Hospital · Observational
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
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 Subjects enrolled in this study must have completed the efficacy and safety follow-up of the main study or withdrawn early from the main study.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.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 40 is below the median of 150 across 486 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →RenJi Hospital is the lead sponsor of 550 studies on the registry; 247 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Previously treated with GC012F Injection
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: No Intervention: Observational Cohort
No Intervention: Observational Cohort
Incidence of specific Aes
Specific AEs include: * New malignancies (defined as new primary malignancies or recurrence of pre-existing malignancies other than MM); * New onset of grade ≥3 infections; * New onset or worsening of pre-existing neurological disorders; ④ New onset or worsening of pre-existing rheumatism/other autoimmune diseases; ⑤ New onset of grade ≥3 hematologic toxicity related to GC012F Injection.
Time frame: 15 years from GC012F Injection administration
Adverse Events (AEs)
Incidence of AEs related to GC012F Injection
Time frame: 15 years from the administration of GC012F Injection
Overall Survival (OS)
The time from the initiation of GC012F Injection treatment to death (from any cause).
Time frame: Long-term follow-up from GC012F Injection administration to 15 years post-dose,
Progression-free Survival (PFS)
The time from the initiation of GC012F Injection treatment to the first occurrence of disease progression or death from any cause
Time frame: Long-term follow-up from GC012F Injection administration to 15 years post-dose,
Duration of Response (DoR)
The time from the first evaluation of sCR, CR, VGPR or PR for the tumor to the first evaluation of disease progression or death from any cause.
Time frame: Long-term follow-up from GC012F Injection administration to 15 years post-dose,
Objective Response Rate (ORR)
According to the 2016 IMWG response evaluation criteria: ORR (sCR + CR + VGPR + PR), ≥VGPR rate (VGPR + CR + sCR), ≥CR rate (CR + sCR);
Time frame: Long-term follow-up from GC012F Injection administration to 15 years post-dose,
Replication-competent lentivirus (RCL) in peripheral blood
Detection of RCL in Peripheral Blood by Real-time Fluorescent Quantitative PCR (q-PCR)
Time frame: Long-term follow-up from GC012F Injection administration to 15 years post-dose,
Minimal residual disease (MRD)
Minimal residual disease (MRD) negativity rate, MRD-negative CR rate, and duration of MRD negativity;
Time frame: Long-term follow-up from GC012F Injection administration to 15 years post-dose,
Last detectable time point (Tlast)
Cytokinetics (CK) profile of GC012F CAR-T celltherapy
Time frame: Long-term follow-up from GC012F Injection administration to 15 years post-dose,
Last quantifiable concentration (Clast)
Cytokinetics (CK) profile of GC012F CAR-T celltherapy
Time frame: Long-term follow-up from GC012F Injection administration to 15 years post-dose,
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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