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Multiple MyelomaNCT07833046

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

An observational study of Multiple Myeloma, run by RenJi Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Any age
Conditions the study is for
Multiple Myeloma
How many people
40 participants
Where
1 siteChina
Study dates
15 Oct 2026to 21 Aug 2039
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Previously treated with GC012F Injection

Who may be able to join

  • 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  • Patients who have completed the safety and efficacy follow-up of the main study or withdrawn early;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;

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Juan Du contact

15800706091

dujuangcp@outlook.com

China1 site

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

    Juan Du, 15800706091, dujuangcp@outlook.com

Other trials in China

About this study

Official title: Long-term Follow-up Study to Evaluate Subjects With Multiple Myeloma 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

Read the detailed description

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.

Being tested
No Intervention: Observational Cohort
Keywords
Multiple myeloma, CAR-T cell therapy
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No Intervention: Observational CohortOther

    No Intervention: Observational Cohort

Study groups in NCT07833046
Study groupRoleWhat they receive
Previously treated with GC012F InjectionNot described
Receives: Other: No Intervention: Observational Cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 15 years from GC012F Injection administration

  2. Adverse Events (AEs)

    Incidence of AEs related to GC012F Injection

    Measured: 15 years from the administration of GC012F Injection

Secondary outcomes (6)

  1. Overall Survival (OS)

    The time from the initiation of GC012F Injection treatment to death (from any cause).

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

  2. 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

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

  3. 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.

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

  4. 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);

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

  5. Replication-competent lentivirus (RCL) in peripheral blood

    Detection of RCL in Peripheral Blood by Real-time Fluorescent Quantitative PCR (q-PCR)

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

  6. Minimal residual disease (MRD)

    Minimal residual disease (MRD) negativity rate, MRD-negative CR rate, and duration of MRD negativity;

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2026
  2. Study start15 Oct 2026 (estimated)
  3. Primary completion21 Mar 2039 (estimated)
  4. Study completion21 Aug 2039 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07833046
Sponsor's protocol ID
N7046000000
Status last verified
Sep 2026
First submitted
15 Sep 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma, run by RenJi Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Juan Du (15800706091, dujuangcp@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of specific Aes (time frame: 15 years from GC012F Injection administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07833046.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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