UnknownEarly Phase 1

Study of FasT CAR-T GC012F Injection NDMM Patients

China18 participantsStarted 2023-05-04

Plain-language summary

This is a single-arm, single-center, open-label clinical study to evaluate the safety and efficacy of CAR-T in patients with NDMM.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥18 when signing informed consent form（ICF）
. Documented evidence of multiple myeloma at diagnosis as defined by IMWG guidelines ,monoclonal plasma cells in the bone marrow ≥10% and/or serum M protein ≥ 3 g/dL and/or 24h urine light chain ≥ 500 mg and/or presence of a biopsy proven plasmacytomas, not meet evidence of Smoldering Myeloma with SLiM/CRAB syptoms, and meet at least 2 of a-c or meet d of the following criteria at screening:
. Serum M protein ≥ 2 g/dL;
. Serum involved / uninvolved free light chain ratio ≥ 20;
. Bone marrow involved with monoclonal plasma cells ≥20% ;
. With Cytogenetic high-risk markers.
. Or documented evidence of multiple myeloma at diagnosis as defined by IMWG guidelines CRAB (calcium elevation, renal insufficiency, anemia, and bone abnormalities)/SLiM criteria, monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy proven plasmacytomas, and measurable secretory disease according to IMWG criteria meet one or more of the following criteria at screening:
. Serum M protein ≥ 1 g/dL;

Exclusion criteria

. Patients who are transplant eligible high-risk patients and plan to adopt auto/allo-transplantation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse Events (AE) after CAR-T infusion

Timeframe: Up to 1 year after patients infused with CAR-T injection

Percentage of patients with complete response (CR) and stringent complete response (sCR) after infusion

Timeframe: Up to 2 years after patients infused with CAR-T injection

overall response rate (ORR)

Timeframe: Up to 2 years after patients infused with CAR-T injection

Percentage of patients with minimal residual disease (MRD) negative in CR/sCR patients at landmark analysis

Timeframe: Up to 2 years after patients infused with CAR-T injection

Progress free survival (PFS)

Timeframe: Up to 2 years after patients infused with GC01 2F injection

Duration of response (DOR) after CAR-T infusion

Timeframe: Up to 2 years after patients infused with GC01 2F injection

Trial details

NCT IDNCT05840107

SponsorShanghai Changzheng Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

Contact for this trial

Juan Du, MD

+86-21 -81885423 changzheng_pg@163.com

View on ClinicalTrials.gov More Multiple Myeloma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥18 when signing informed consent form（ICF）
. Documented evidence of multiple myeloma at diagnosis as defined by IMWG guidelines ,monoclonal plasma cells in the bone marrow ≥10% and/or serum M protein ≥ 3 g/dL and/or 24h urine light chain ≥ 500 mg and/or presence of a biopsy proven plasmacytomas, not meet evidence of Smoldering Myeloma with SLiM/CRAB syptoms, and meet at least 2 of a-c or meet d of the following criteria at screening:
. Serum M protein ≥ 2 g/dL;
. Serum involved / uninvolved free light chain ratio ≥ 20;
. Bone marrow involved with monoclonal plasma cells ≥20% ;
. With Cytogenetic high-risk markers.
. Or documented evidence of multiple myeloma at diagnosis as defined by IMWG guidelines CRAB (calcium elevation, renal insufficiency, anemia, and bone abnormalities)/SLiM criteria, monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy proven plasmacytomas, and measurable secretory disease according to IMWG criteria meet one or more of the following criteria at screening:
. Serum M protein ≥ 1 g/dL;

Exclusion criteria

. Patients who are transplant eligible high-risk patients and plan to adopt auto/allo-transplantation

What they're measuring

Adverse Events (AE) after CAR-T infusion

Timeframe: Up to 1 year after patients infused with CAR-T injection

Percentage of patients with complete response (CR) and stringent complete response (sCR) after infusion

Timeframe: Up to 2 years after patients infused with CAR-T injection

overall response rate (ORR)

Timeframe: Up to 2 years after patients infused with CAR-T injection

Percentage of patients with minimal residual disease (MRD) negative in CR/sCR patients at landmark analysis

Timeframe: Up to 2 years after patients infused with CAR-T injection

Progress free survival (PFS)

Timeframe: Up to 2 years after patients infused with GC01 2F injection

Duration of response (DOR) after CAR-T infusion

Timeframe: Up to 2 years after patients infused with GC01 2F injection