Multiple MyelomaEarly Phase 1NCT04236011
BCMA and CD19 Targeted Fast Dual CAR-T for BCMA+ Refractory/Relapsed Multiple Myeloma
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, open-label, multi-center prospective study to determine the safety and efficacy of GC012F CAR-T cells in patients diagnosed with BCMA+ refractory/relapsed multiple myeloma (r/r MM). 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
- 15 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2020to 31 Dec 2022
- 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
- Patients must have a confirmed prior diagnosis of active multiple myeloma as defined by the updated IMWG criteria;
- Diagnosis of MM with relapsed or refractory disease. Definition of Refractory/relapse:
- Have had at least 3 prior lines of therapy or primary refractory as defined by Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1. Prior therapy should include PI and IMiD. Note: Patients should undergone at least have at least complete 1 cycle treatment in each line. Induction with or without hematopoietic stem cell transplant followed by maintenance therapy is considered a single line of therapy.
- Have had at least 2 prior lines of therapy when refractory to both immunomodulatory drug (IMiD) and proteasome inhibitor(PI) (Refractory was defined by IMWG consensus criteria);
- Estimated life expectancy ≥3 months;
- Hemoglobin ≥ 8.0 g/dL;
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- Absolute neutrophil count ≥ 0.75*10E9/L;
- Platelet count ≥ 50*10E9/L;
- Absolute lymphocyte count ≥ 1*10E8/L;
- Liver, kidney and cardiopulmonary functions meet the following requirements: a)Total bilirubin ≤ 2×ULN(except for Gilbert Syndrome); ALT and/or AST ≤3 × ULN; b)clearance of serum creatinine ≥ 40 mL/min, calculated by Cockcroft-Gault; c)Corrected serum calcium ≤ 12.5mg/dL or free ion calcium ≤ 6.5mg/dL(1.6mmol/L);
- Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis;
- Subjects and sexual partner with fertility are willing to use effective and reliable method of contraception for at least 100 days after CART cell infusion;
- Subjects must have signed written, informed consent.
Who cannot join
- Accompanied by other uncontrolled malignancies.There are two exceptions to this criterion: Recepted radical therapy carcinoma without activity within 3 years before screening; and fully treated skin non-melanoma;
- Any situations not benefit for subjects to accept or tolerated to planned therapy or understand informed consent; or any situation in which investigators believe that participation in this study is not in the subject's best interests (e.g., harm to health), or any situation that may prevent, limit or confuse the assessment;
- Convulsion or stoke within past 6 months;
- Any instability of systemic disease within 6 months prior to screening, including but not limited to congestive heart failure (New York heart association (NYHA) classification ≥ III), unstable angina, cerebrovascular accident, or transient cerebral ischemic, myocardial infarction,LEVF< 45% (assessed by an echocardiogram or multi-door circuit scan );
- Patients have central nervous system (CNS) metastases or CNS involvement (including cranial neuropathies or mass lesions and leptomeningeal disease);
- Subjects with positive HBsAg or HBcAb postive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; syphilis primary screening antibody positive;
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- Presence or suspicion of fungi, bacteria, viruses or other infections that are uncontrollable or requiring intravenous treatment;
- Activity of autoimmune diseases (such as crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), orhistory of autoimmune disease within the last 3 years;
- Clinical evidence of dementia or changes of mental state.
- Exist of pulmonary fibrosis;
- Allergy subjects or history of severe hypersensitivity;
- Oxygen inhalation requirment to maintain adequate oxygen saturation;
- Surgery (except for local anesthesia surgery) plan 2 weeks before apheresis. during or 2 weeks after CART infusion;
- Chemotherapy forbidden for cyclophosphamide or fludarabine;
- Pregnant or lactating, or planning to have a pregnancy during or within 100 days after treatment;
- Patients who are accounted to be not appropriate for this trail by investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality
Weijun Fu
About this study
Official title: Exploratory Study to Evaluate Efficacy and Safety of GC012F Injection in BCMA+ Refractory/Relapsed Multiple Myeloma
This is a single arm, open-label, multi-center prospective study to determine the safety and efficacy of GC012F CAR-T cells in patients diagnosed with BCMA+ refractory/relapsed multiple myeloma (r/r MM).
Read the detailed description
The main aim of the study is to determine the safety and efficacy of GC012F in r/r MM. GC012F is an autologous dual chimeric antigen receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA) and CD19. This study comprises of a Screening Phase (less than or equal to [<=] 28 days prior to apheresis) followed by Apheresis (will occur upon enrollment); Treatment Phase including a conditioning regimen followed by infusion of GC012F and post-infusion assessments from Day 1 to Day 84; and a Post-treatment Phase (Day 85 and up to end of the study). Efficacy will be explored to assessed and safety will be closely monitored during the study.
- Conditions
- Multiple Myeloma
- Being tested
- GC012F injection
- Keywords
- Fast, Chimeric Antigen Receptor T, BCMA, CD19, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC012F injectionBiological
GC012F injection is a autologous dual CAR-T targeted BCMA and CD19. A single infusion of CART cells will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| GC012F treatment | Experimental | BCMA+ R/R multiple myeloma patients be treated with a single dose of GC012F cells. Total dose of (1-5)*10E5/kg cells will be administered at Day 0. Receives: Biological: GC012F injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events after GC012F infusion
Measured: up to 24 weeks after GC012F infusion
Secondary outcomes (9)
Percentage of MRD negative patients after GC012F treatment
Measured: 12 weeks, 24 weeks after GC012F infusion
ORR (PR, VGPR, CR and sCR) of patients receive GC012F treatment
Measured: 12 weeks, 24 weeks after GC012F infusion
Progression free survival after GC012F treatment
Measured: 12 weeks, 24 weeks after GC012F infusion
Copies and cell counts of CAR in blood and bone marrow (if available) after GC012F treatment
Bone marrows will be collected in weeks 4, 8, 12, 18, 24 after GC012F infusion.
Measured: Days 4, 7, 10, 14 and weeks 4, 8, 12, 18, 24 after GC012F infusion
Cytokines in serum after GC012F treatment
Measured: Days 4, 7, 10, 14 and weeks 4, 8, 12, 18, 24 after GC012F infusion
Subset of lymphocytes and ADA in blood after GC012F treatment
Measured: Weeks 4, 8, 12, 18, 24 after GC012F infusion
Replication competent lentivirus (RCL) in blood after GC012F treatment
Measured: Weeks 4, 12, 24 after GC012F infusion
Duration of response after GC012F treatment
Measured: 12 weeks, 24 weeks after GC012F infusion
Overall survival after GC012F treatment
Measured: 12 weeks, 24 weeks after GC012F infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start16 Jan 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 15 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, Weijun Fu, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236011
- Sponsor's protocol ID
- GBF002
- Status last verified
- Jun 2021
- First submitted
- 15 Jan 2020
- Last updated
- 15 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Evaluate Efficacy and Safety of GC012F Injection in BCMA+ Refractory/Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04236011
- Acronym / sponsor ID
- GBF002
- Conditions
- Multiple Myeloma
- Keywords
- Fast, Chimeric Antigen Receptor T, BCMA, CD19, Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- Gracell Biotechnologies (Shanghai) Co., Ltd.
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Jan 2020 (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, open-label, multi-center prospective study to determine the safety and efficacy of GC012F CAR-T cells in patients diagnosed with BCMA+ refractory/relapsed multiple myeloma (r/r MM).
Detailed description
The main aim of the study is to determine the safety and efficacy of GC012F in r/r MM. GC012F is an autologous dual chimeric antigen receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA) and CD19. This study comprises of a Screening Phase (less than or equal to [<=] 28 days prior to apheresis) followed by Apheresis (will occur upon enrollment); Treatment Phase including a conditioning regimen followed by infusion of GC012F and post-infusion assessments from Day 1 to Day 84; and a Post-treatment Phase (Day 85 and up to end of the study). Efficacy will be explored to assessed and safety will be closely monitored during the study.
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 injectionBCMA+ R/R multiple myeloma patients be treated with a single dose of GC012F cells. Total dose of (1-5)*10E5/kg cells will be administered at Day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must have a confirmed prior diagnosis of active multiple myeloma as defined by the updated IMWG criteria;
- Diagnosis of MM with relapsed or refractory disease. Definition of Refractory/relapse:
- Estimated life expectancy ≥3 months;
- Hemoglobin ≥ 8.0 g/dL;
- Absolute neutrophil count ≥ 0.75*10E9/L;
Key exclusion criteria (16 listed)
- Accompanied by other uncontrolled malignancies.There are two exceptions to this criterion: Recepted radical therapy carcinoma without activity within 3 years before screening; and fully treated skin non-melanoma;
- Any situations not benefit for subjects to accept or tolerated to planned therapy or understand informed consent; or any situation in which investigators believe that participation in this study is not in the subject's best interests (e.g., harm to health), or any situation that may prevent, limit or confuse the assessment;
- Convulsion or stoke within past 6 months;
- Any instability of systemic disease within 6 months prior to screening, including but not limited to congestive heart failure (New York heart association (NYHA) classification ≥ III), unstable angina, cerebrovascular accident, or transient cerebral ischemic, myocardial infarction,LEVF< 45% (assessed by an echocardiogram or multi-door circuit scan );
- Patients have central nervous system (CNS) metastases or CNS involvement (including cranial neuropathies or mass lesions and leptomeningeal disease);
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 a autologous dual CAR-T targeted BCMA and CD19. A single infusion of CART cells will be administered intravenously. | Biological | GC012F treatment |
Primary outcome
Incidence and severity of adverse events after GC012F infusion
Time frame: up to 24 weeks after GC012F infusion
9 secondary outcomes
Percentage of MRD negative patients after GC012F treatment
Time frame: 12 weeks, 24 weeks after GC012F infusion
ORR (PR, VGPR, CR and sCR) of patients receive GC012F treatment
Time frame: 12 weeks, 24 weeks after GC012F infusion
Progression free survival after GC012F treatment
Time frame: 12 weeks, 24 weeks after GC012F infusion
Copies and cell counts of CAR in blood and bone marrow (if available) after GC012F treatment
Time frame: Days 4, 7, 10, 14 and weeks 4, 8, 12, 18, 24 after GC012F infusion
Cytokines in serum after GC012F treatment
Time frame: Days 4, 7, 10, 14 and weeks 4, 8, 12, 18, 24 after GC012F infusion
Subset of lymphocytes and ADA in blood after GC012F treatment
Time frame: Weeks 4, 8, 12, 18, 24 after GC012F infusion
Replication competent lentivirus (RCL) in blood after GC012F treatment
Time frame: Weeks 4, 12, 24 after GC012F infusion
Duration of response after GC012F treatment
Time frame: 12 weeks, 24 weeks after GC012F infusion
Overall survival after GC012F treatment
Time frame: 12 weeks, 24 weeks after GC012F infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 13 inclusion and 16 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 15 Jun 2021. 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 Weijun Fu ((+86)13816052522, fuweijun2010@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events after GC012F infusion (time frame: up to 24 weeks after GC012F infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2021.