Multiple MyelomaEarly Phase 1NCT05840107
Study of FasT CAR-T GC012F Injection NDMM Patients
A Early Phase 1 study testing GC012F injection in people with Multiple Myeloma, run by Shanghai Changzheng Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- GC012F injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2023to 30 Sep 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 24Show fewer
- 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;
- Urine M protein ≥ 200 mg/24h;
- Serum free light chain sFLC ≥ 10 mg/dL with abnormal serum immunoglobulin κ/λ free light chain ratio.
- ECOG score was 0-3 at screen;
- Estimated life expectancy ≥3 months;
- Absolute neutrophil count (ANC) ≥ 1.5×10^9/L without use of growth factors;
- Platelet count ≥ 50×10^9/L without transfusion support within 7 days before the screen;
- Hemoglobin≥ 60 g/L;
- Adequate functional reserve of organs:
- ALT/AST ≤ 2.5× ULN(Upper Limit of Normal);
- Creatinine clearance ≥ 15mL/min;
- Serum total bilirubin ≤ 1.5×ULN, except in subjects with congenital bilirubinemia,then direct bilirubin ≤ 1.5×ULN;
- The left ventricular ejection fraction (LVEF)≥50%, and no clinically significant ECG abnormalities were found;
- Basic oxygen saturation in natural indoor air: SPO2>92%.
- Adequate venous access for apheresis collection, and no other contraindications to apheresis;
- Subjects and sexual partner with fertility are willing to use effective and reliable method of contraception for at least 1 year after CAR-T cell infusion, serum HCG should be negative in females with fertility both at screening and baseline;
- Subjects must sign a written informed consent.
Who cannot join
- Patients who are transplant eligible high-risk patients and plan to adopt auto/allo-transplantation
- Subject has had radiation therapy within 14 days of screening;
- Subjects has plasma cell leukemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes);
- Subjects has a diagnosis of primary amyloidosis, Waldenstroem's disease, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma;
- Having other tumors (excluding non-melanoma skin cancer and cervical cancer in situ bladder cancer and breast cancer that have been disease-free for more than 5 years);
- Evidence of serious mental disorders or changes in mental status, or the presence of central nervous system or diseases, such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or autoimmune diseases involving CNS;
Show all 19Show fewer
- History of hereditary diseases such as Fanconi anemia, Schrader syndrome, Costerman syndrome, or any other known bone marrow failure syndrome;
- Clinically significant cardiac disease including: uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities, grade III-IV heart failure or myocardial infarction cardiac angioplasty or stenting unstable angina or other clinically significant cardiac conditions within one year prior to enrollment;
- Presence of any indwelling catheter or drainage tube (e.g., percutaneous nephrostomy catheter indwelling catheter bile drainage tube or pleural/peritoneal/pericardial catheter) The use of a dedicated central venous catheter is permitted;
- Confirmed or suspected CNS involved;
- A positive virological result for any of the following: HIV, HCV, HBsAg（If HBcAg positive, DNA copies must below the LOQ）, TPPA;
- Other severe viral or bacterial infections or uncontrolled systemic fungal infections are present;
- Severe allergic history or allergic constitution;
- There is a history of an autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that has resulted in terminal organ damage or requires systemic immunosuppressive/disease modulating drugs in the past 2 years;
- Presence of lung disease (such as pulmonary fibrosis);
- Subjects has had major surgery within 2 weeks before screen or has not fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study;
- Poor compliance due to physiological, family, social, and geographical factors, etc., and inability to comply with the research program and follow-up plan;
- Pregnant or lactating women;
- Investigator assessment deemed to be ineligible.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Juan Du, MD, +86215021598406, juan_du@live.com
About this study
Official title: CAR-T Injection in Transplant In-Eligible Newly Diagnosed Multiple Myeloma Patients
This is a single-arm, single-center, open-label clinical study to evaluate the safety and efficacy of CAR-T in patients with NDMM.
Read the detailed description
9-18 evaluable subjects are planned to be enrolled in this study. Apheresis will be carried out in subjects who meet eligible criteria, and total 2 cycles of induction therapy (three-drug combination regimen based on bortezomib with details determined by the investigator according to the patient's condition) will be selectively given to subjects before or after apheresis. Next, subjects will receive a single infusion of CAR-T, and the efficacy assessments will be performed at 1st month, 3rd months, and every 3 months within 2 years until the end of the trial (MRD testing is required for each efficacy assessment)
1.Efficacy assessments performed at the 1st month after infusion:
- <PR: Protocol change or follow-up decided by the investigator.
- ≥PR: Follow-up.
2.Efficacy assessments performed at the 3rd month after infusion and every 3 months thereafter:
- <VGPR: Protocol change or follow-up decided by the investigator.
- ≥VGPR: Maintenance treatment using lenalidomide until progress disease or clinical trial intolerance or termination of trial.
After signing the informed consent form (ICF), subjects will be followed up for efficacy and safety until 2 years after CAR-T infusion, or disease progression, or death, or withdrawal of consent, or any intolerable toxicity, whichever comes first. All AEs in subjects, especially infection related symptoms and signs, will be closely monitored during follow-up, and prophylactic treatment will be administered according to clinical practice when necessary. In case of disease progression within 2 years after CAR-T infusion, treatment will be administered according to clinical practice, and the survival follow-up (only for the survival status) will be performed every 12 weeks±14 days (2 weeks) until 2 years after infusion, or death, or withdrawal of consent, whichever comes first. For subjects who have undergone transportation or any other clinical routine treatments after CAR-T infusion, survival follow-up will be also performed as described above.
- Conditions
- Multiple Myeloma
- Being tested
- GC012F injection
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC012F injectionBiological
GC012F injection is an autologous dual CAR-T targeted BCMA and CD19. A single infusion of CAR-T cells will be administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| GC012F treatment | Experimental | CAR-T will be infused at a dose of 0.6,1.5,3 x 10^5 CAR-T cells/kg after receiving lymphodepleting chemotherapy. Lenalidomide maintenance therapy will be given post month 6 at physicians' choice. Receives: Biological: GC012F injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE) after CAR-T infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), with the exception of cytokine release syndrome (CRS), and immune effector cellassociated neurotoxicity syndrome (ICANS). CRS and ICANS should be evaluated according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading
Measured: 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
Measured: Up to 2 years after patients infused with CAR-T injection
overall response rate (ORR)
ORR defined as proportion of patients achieving PR or better based on IMWG defined response criteria
Measured: 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
MRD negative rate
Measured: Up to 2 years after patients infused with CAR-T injection
Progress free survival (PFS)
PFS is defined as the time interval from the initiation of induction therapy until disease progression or death (for any reason).
Measured: Up to 2 years after patients infused with GC01 2F injection
Duration of response (DOR) after CAR-T infusion
DOR is defined as the time interval from the first assessment of sCR, CR, VGPR or PR to the first assessment of PD or death from any cause after CAR T infusion.
Measured: Up to 2 years after patients infused with GC01 2F injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start4 May 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gracell Biotechnologies (Shanghai) Co., Ltd.
- Responsible party
- Principal investigator, Juan Du, Shanghai Changzheng Hospital
- Investigators
- Juan Du, MD, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840107
- Sponsor's protocol ID
- GC012F-322
- Status last verified
- Feb 2024
- First submitted
- 22 Apr 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu J, Fan X, Peng L, Liu J, He H, Qiang W, Jin L, Shi L, Lu J, Guo P, Shah N, Zhang Q, Shen L, Du J. BCMA/CD19 dual-targeting CAR T-cell therapy in older patients with newly diagnosed multiple myeloma: a phase 1 study. Blood Adv. 2026 Jun 23;10(12):4134-4143. doi: 10.1182/bloodadvances.2025019036.
PubMed 41925575
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAR-T Injection in Transplant In-Eligible Newly Diagnosed Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT05840107
- Acronym / sponsor ID
- GC012F-322
- Conditions
- Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- Gracell Biotechnologies (Shanghai) Co., Ltd.
- Study start
- 4 May 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, single-center, open-label clinical study to evaluate the safety and efficacy of CAR-T in patients with NDMM.
Detailed description
9-18 evaluable subjects are planned to be enrolled in this study. Apheresis will be carried out in subjects who meet eligible criteria, and total 2 cycles of induction therapy (three-drug combination regimen based on bortezomib with details determined by the investigator according to the patient's condition) will be selectively given to subjects before or after apheresis. Next, subjects will receive a single infusion of CAR-T, and the efficacy assessments will be performed at 1st month, 3rd months, and every 3 months within 2 years until the end of the trial (MRD testing is required for each efficacy assessment)
1.Efficacy assessments performed at the 1st month after infusion:
- <PR: Protocol change or follow-up decided by the investigator.
- ≥PR: Follow-up.
2.Efficacy assessments performed at the 3rd month after infusion and every 3 months thereafter:
- <VGPR: Protocol change or follow-up decided by the investigator.
- ≥VGPR: Maintenance treatment using lenalidomide until progress disease or clinical trial intolerance or termination of trial.
After signing the informed consent form (ICF), subjects will be followed up for efficacy and safety until 2 years after CAR-T infusion, or disease progression, or death, or withdrawal of consent, or any intolerable toxicity, whichever comes first. All AEs in subjects, especially infection related symptoms and signs, will be closely monitored during follow-up, and prophylactic treatment will be administered according to clinical practice when necessary. In case of disease progression within 2 years after CAR-T infusion, treatment will be administered according to clinical practice, and the survival follow-up (only for the survival status) will be performed every 12 weeks±14 days (2 weeks) until 2 years after infusion, or death, or withdrawal of consent, whichever comes first. For subjects who have undergone transportation or any other clinical routine treatments after CAR-T infusion, survival follow-up will be also performed as described above.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GC012F treatment | Experimental | Biological: GC012F injectionCAR-T will be infused at a dose of 0.6,1.5,3 x 10^5 CAR-T cells/kg after receiving lymphodepleting chemotherapy. Lenalidomide maintenance therapy will be given post month 6 at physicians' choice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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:
- 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:
- ECOG score was 0-3 at screen;
- Estimated life expectancy ≥3 months;
Key exclusion criteria (19 listed)
- Patients who are transplant eligible high-risk patients and plan to adopt auto/allo-transplantation
- Subject has had radiation therapy within 14 days of screening;
- Subjects has plasma cell leukemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes);
- Subjects has a diagnosis of primary amyloidosis, Waldenstroem's disease, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma;
- Having other tumors (excluding non-melanoma skin cancer and cervical cancer in situ bladder cancer and breast cancer that have been disease-free for more than 5 years);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC012F injectionGC012F injection is an autologous dual CAR-T targeted BCMA and CD19. A single infusion of CAR-T cells will be administered intravenously | Biological | GC012F treatment |
Primary outcome
Adverse Events (AE) after CAR-T infusion
Time frame: Up to 1 year after patients infused with CAR-T injection
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), with the exception of cytokine release syndrome (CRS), and immune effector cellassociated neurotoxicity syndrome (ICANS). CRS and ICANS should be evaluated according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading
Percentage of patients with complete response (CR) and stringent complete response (sCR) after infusion
Time frame: Up to 2 years after patients infused with CAR-T injection
overall response rate (ORR)
Time frame: Up to 2 years after patients infused with CAR-T injection
ORR defined as proportion of patients achieving PR or better based on IMWG defined response criteria
Percentage of patients with minimal residual disease (MRD) negative in CR/sCR patients at landmark analysis
Time frame: Up to 2 years after patients infused with CAR-T injection
MRD negative rate
Progress free survival (PFS)
Time frame: Up to 2 years after patients infused with GC01 2F injection
PFS is defined as the time interval from the initiation of induction therapy until disease progression or death (for any reason).
Duration of response (DOR) after CAR-T infusion
Time frame: Up to 2 years after patients infused with GC01 2F injection
DOR is defined as the time interval from the first assessment of sCR, CR, VGPR or PR to the first assessment of PD or death from any cause after CAR T infusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Derived from this study: PubMed 41925575Liu J, Fan X, Peng L, Liu J, He H, Qiang W, Jin L, Shi L, Lu J, Guo P, Shah N, Zhang Q, Shen L, Du J. BCMA/CD19 dual-targeting CAR T-cell therapy in older patients with newly diagnosed multiple myeloma: a phase 1 study. Blood Adv. 2026 Jun 23;10(12):4134-4143. doi: 10.1182/bloodadvances.2025019036.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Du, MD principal investigator
Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing GC012F injection in people with Multiple Myeloma, run by Shanghai Changzheng 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 24 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 13 Feb 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Du, MD (+86-21 -81885423, changzheng_pg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AE) after CAR-T infusion (time frame: Up to 1 year after patients infused with CAR-T injection). The study lists 6 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 NCT05840107, which also lists 1 linked publication.
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 13 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.