Multiple MyelomaEarly Phase 1NCT04617704
BCMA and CD19 Targeted Fast Dual CART for Chromosomal Abnomalities High-risk BCMA+ 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 explory the safety and efficacy of GC012F CAR-T cells in patient diagnosed with high-risk chromosomal abnormalities BCMA+ multiple myeloma(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
- 1 Dec 2021to 1 Feb 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
- Diagnosis of active MM as defined by any of following: a) serum M protein more than or equal to 10g/dL; b) urine M protein more than or equal to 200mg/24 h; c) involved serum free light chain more than or equal to 100mg/dL with abnormal serum kappa lambda ratio;
- Patients with clear BCMA expression(percent of BCMA positive plasma cells more than or equal to 20%) detected by flow cytometry;
- High-risk chromosomal abnormal defined as presence of del17p, and/or t(4;14) and/or t(14;16);
- Estimated life expectancy more than or equal to 3 months;
- Absolute neutrophil count more than or equal to 1*10^9/L;
- Platelet count more than or equal to 25*10^9/L;
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- Absolute lymphocyte count more than or equal to 1*10^8/L;
- Liver, kidney and cardiopulmonary functions meet the following requirements: a) Total bilirubin less than or equal to 2*ULN(except for Gilbert Syndrome); ALT and AST less than or equal to 2.5*ULN, maintenance of kidney function not depend on dialysis; c)Corrected serum calcium less than or equal to 12.5 mg/dL or free ion calcium less than or equal to 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 1 year after CAR-T infusion;
- subjects must have signed writtern informed consent.
Who cannot join
- Accompanied by other unctrolled maligancies. Two exceptions to this criteria: Recepted radical therapy carcinoma without activity within 3 years before screening; 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 intreat(eg., harm to health), or any situation that may prevent, limit or confuse the assessment;
- Convulsion or stoke within past 6 months;
- Any instability or systemic disease within 6 months prior to screening, including but not limited to congestive heart failure(New York heart association classification ≥ III)， unstable angina, cerebrovascular accident, or transient cerebral ischemic, myocardial infarction, LEVF<50%(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 positive and peripheal 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 suspicious of fungi, bacteria, viruses or other infections that are uncontrollable or requiring intravenous treatment;
- Activity of autoimmune disease (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;
- Oxgen inhalation requirement to maintain adequate oxygen saturation;
- Surgery (except for local anesthesia surgery) plan 2 weeks before apheresis, during or 2 weeks after CAR-T infusion;
- Patients who are accounted to be not appropriate for this investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study to Evaluate Efficacy and Safety of GC012F Injection in Chromosomal Abnomalities High-risk BCMA+ Multiple Myeloma
This is a single arm, open label, multi-center prospective study to explory the safety and efficacy of GC012F CAR-T cells in patient diagnosed with high-risk chromosomal abnormalities BCMA+ multiple myeloma(MM).
Read the detailed description
The main aim of this study is to determin the safety and efficacy of GC012F in cytogenetic high-risk MM. GC012F is an autologus 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 enroiiment); Treatment Phase including autologus stem cell transplant on Day-1 followed by infusion of GC012F on Day0 and then post-infusion assessments from Day1 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
- high-risk, 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 CAR-T cells will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Experimental:GC012F treatment | Experimental | BCMA+ cytogenetic high-risk multiple myeloma patients be treated with a single dose of GC012F cells. Total dose of (1-5)*10^5/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 injection
Measured: Minimum 2 years after GC012F infusion
Secondary outcomes (10)
Percentage of MRD negative patients after GC012F infusion
Measured: Minimum 2 years after GC012F infusion
ORR(PR, VGPR, CR and sCR) of patients after GC012F treatment
percent of subjects who achieving PR or better after GC012F infusion
Measured: Minimum 2 years after GC012F infusion(Day0)
Progression free survival after GC012F treatment
Measured: Minimum 2 years after GC012F infusion(Day0)
Duration of response of subjects after GC012F treatment
Measured: Minimum 2 years after GC012F infusion(Day0)
Overall survivalof subjects after GC012F treatment
Measured: Minimum 2 years after GC012F infusion(Day0)
Cytokines in serum after GC012F infusion
Measured: Minimum 24 weeks after GC012F infusion(Day0)
Subset of lymphocytes in blood after GC012F infusion
Measured: Minimum 2 years after GC012F infusion(Day0)
Anti-GC012F antibodies in blood after GC012F infusion
Measured: Minimum 2 years after GC012F infusion(Day0)
Cell counts of GC012F in blood and bone marrow(if available) after GC012F infusion
Measured: Minimum 2 years after GC012F infusion(Day0)
Copies of GC012F in blood and bone marrow(if available) after GC012F infusion
Measured: Minimum 2 years after GC012F infusion(Day0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Dec 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Feb 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
- NCT04617704
- Sponsor's protocol ID
- GBF003
- Status last verified
- Oct 2020
- First submitted
- 20 Aug 2020
- Last updated
- 22 Sep 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 22 Sep 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 Chromosomal Abnomalities High-risk BCMA+ Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04617704
- Acronym / sponsor ID
- GBF003
- Conditions
- Multiple Myeloma
- Keywords
- high-risk, 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
- 1 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 5 Nov 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 explory the safety and efficacy of GC012F CAR-T cells in patient diagnosed with high-risk chromosomal abnormalities BCMA+ multiple myeloma(MM).
Detailed description
The main aim of this study is to determin the safety and efficacy of GC012F in cytogenetic high-risk MM. GC012F is an autologus 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 enroiiment); Treatment Phase including autologus stem cell transplant on Day-1 followed by infusion of GC012F on Day0 and then post-infusion assessments from Day1 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 |
|---|---|---|
| Experimental:GC012F treatment | Experimental | Biological: GC012F injectionBCMA+ cytogenetic high-risk multiple myeloma patients be treated with a single dose of GC012F cells. Total dose of (1-5)*10^5/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 (11 listed)
- Diagnosis of active MM as defined by any of following: a) serum M protein more than or equal to 10g/dL; b) urine M protein more than or equal to 200mg/24 h; c) involved serum free light chain more than or equal to 100mg/dL with abnormal serum kappa lambda ratio;
- Patients with clear BCMA expression(percent of BCMA positive plasma cells more than or equal to 20%) detected by flow cytometry;
- High-risk chromosomal abnormal defined as presence of del17p, and/or t(4;14) and/or t(14;16);
- Estimated life expectancy more than or equal to 3 months;
- Absolute neutrophil count more than or equal to 1*10^9/L;
Key exclusion criteria (14 listed)
- Accompanied by other unctrolled maligancies. Two exceptions to this criteria: Recepted radical therapy carcinoma without activity within 3 years before screening; 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 intreat(eg., harm to health), or any situation that may prevent, limit or confuse the assessment;
- Convulsion or stoke within past 6 months;
- Any instability or systemic disease within 6 months prior to screening, including but not limited to congestive heart failure(New York heart association classification ≥ III)， unstable angina, cerebrovascular accident, or transient cerebral ischemic, myocardial infarction, LEVF<50%(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 CAR-T cells will be administered intravenously. | Biological | Experimental:GC012F treatment |
Primary outcome
Incidence and severity of adverse events after GC012F injection
Time frame: Minimum 2 years after GC012F infusion
10 secondary outcomes
Percentage of MRD negative patients after GC012F infusion
Time frame: Minimum 2 years after GC012F infusion
ORR(PR, VGPR, CR and sCR) of patients after GC012F treatment
Time frame: Minimum 2 years after GC012F infusion(Day0)
Progression free survival after GC012F treatment
Time frame: Minimum 2 years after GC012F infusion(Day0)
Duration of response of subjects after GC012F treatment
Time frame: Minimum 2 years after GC012F infusion(Day0)
Overall survivalof subjects after GC012F treatment
Time frame: Minimum 2 years after GC012F infusion(Day0)
Cytokines in serum after GC012F infusion
Time frame: Minimum 24 weeks after GC012F infusion(Day0)
Subset of lymphocytes in blood after GC012F infusion
Time frame: Minimum 2 years after GC012F infusion(Day0)
Anti-GC012F antibodies in blood after GC012F infusion
Time frame: Minimum 2 years after GC012F infusion(Day0)
Cell counts of GC012F in blood and bone marrow(if available) after GC012F infusion
Time frame: Minimum 2 years after GC012F infusion(Day0)
Copies of GC012F in blood and bone marrow(if available) after GC012F infusion
Time frame: Minimum 2 years after GC012F infusion(Day0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 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 11 inclusion and 14 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 22 Sep 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 (+8613816052522 ext. +8613816052522, 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 injection (time frame: Minimum 2 years 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 22 Sep 2021.