Clinical trial · Observational
Long-term Follow-up Study in Subjects With Multiple Myeloma Previously Treated With GC012F Injection
Long-term Follow-up Study to Evaluate Subjects With Multiple Myeloma Treated With GC012F Injection
NCT07833046CI-TRIAL-00126521not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention: Observational Cohort | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Previously treated with GC012F Injection
- interventionNames
- Other: No Intervention: Observational Cohort
Primary outcomes (2)
- measure
- Incidence of specific Aes
- timeFrame
- 15 years from GC012F Injection administration
- description
- 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.
- measure
- Adverse Events (AEs)
- timeFrame
- 15 years from the administration of GC012F Injection
- description
- Incidence of AEs related to GC012F Injection
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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an investigator-initiated trial; * Patients who have completed the safety and efficacy follow-up of the main study or withdrawn early; * Patients who agree to sign the informed consent form and are willing and able to comply with the visits, laboratory tests, and other protocol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;
References
Publications (0)
Data not yet available
No reference posted for this study.