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

ConditionMultiple Myeloma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorRenJi Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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Patients who have completed the safety and efficacy follow-up of the main study or withdrawn early;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

Disqualifiers

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 population

Previously treated with GC012F Injection

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

  • No Intervention: Observational Cohort

    Other intervention

    No Intervention: Observational Cohort

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Previously treated with GC012F Injection1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
15 years from GC012F Injection administration
2

Adverse Events (AEs)

Incidence of AEs related to GC012F Injection

Time frame
15 years from the administration of GC012F Injection

Secondary outcomes

1

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,
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

Time frame
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.

Time frame
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);

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

Other outcomes

1

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,
2

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,

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Gracell Biotechnologies (Shanghai) Co., Ltd.

Collaborator

AstraZeneca Global R&D (China) Co., Ltd.

Collaborator

AstraZeneca Global R&D (Beijing) Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: