NCT07833046

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
156mo left

Started Oct 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

October 15, 2026

Expected
12.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2039

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2039

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

12.4 years

First QC Date

September 15, 2026

Last Update Submit

September 21, 2026

Conditions

Multiple Myeloma

Keywords

Multiple myelomaCAR-T cell therapy

Outcome Measures

Primary Outcomes (2)

  • 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.

    15 years from GC012F Injection administration

  • Adverse Events (AEs)

    Incidence of AEs related to GC012F Injection

    15 years from the administration of GC012F Injection

Secondary Outcomes (6)

  • Overall Survival (OS)

    Long-term follow-up from GC012F Injection administration to 15 years post-dose,

  • Progression-free Survival (PFS)

    Long-term follow-up from GC012F Injection administration to 15 years post-dose,

  • Duration of Response (DoR)

    Long-term follow-up from GC012F Injection administration to 15 years post-dose,

  • Objective Response Rate (ORR)

    Long-term follow-up from GC012F Injection administration to 15 years post-dose,

  • Replication-competent lentivirus (RCL) in peripheral blood

    Long-term follow-up from GC012F Injection administration to 15 years post-dose,

  • +1 more secondary outcomes

Other Outcomes (2)

  • Last detectable time point (Tlast)

    Long-term follow-up from GC012F Injection administration to 15 years post-dose,

  • Last quantifiable concentration (Clast)

    Long-term follow-up from GC012F Injection administration to 15 years post-dose,

Study Arms (1)

Previously treated with GC012F Injection

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational CohortOTHER

No Intervention: Observational Cohort

Previously treated with GC012F Injection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Previously treated with GC012F Injection

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Juan Du

CONTACT

15800706091dujuangcp@outlook.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 15, 2026

First Posted

September 22, 2026

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

March 21, 2039

Study Completion (Estimated)

August 21, 2039

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)