Description:
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).
Title
- Brief Title: BCMA and CD19 Targeted Fast Dual CART for Chromosomal Abnomalities High-risk BCMA+ Multiple Myeloma
- Official Title: Exploratory Study to Evaluate Efficacy and Safety of GC012F Injection in Chromosomal Abnomalities High-risk BCMA+ Multiple Myeloma
Clinical Trial IDs
- ORG STUDY ID:
GBF003
- NCT ID:
NCT04617704
Conditions
Interventions
Drug | Synonyms | Arms |
---|
GC012F injection | | Experimental:GC012F treatment |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
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 | |
Eligibility Criteria
Inclusion Criteria:
1. 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;
2. Patients with clear BCMA expression(percent of BCMA positive plasma cells more than or
equal to 20%) detected by flow cytometry;
3. High-risk chromosomal abnormal defined as presence of del17p, and/or t(4;14) and/or
t(14;16);
4. Estimated life expectancy more than or equal to 3 months;
5. Absolute neutrophil count more than or equal to 1*10^9/L;
6. Platelet count more than or equal to 25*10^9/L;
7. Absolute lymphocyte count more than or equal to 1*10^8/L;
8. 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);
9. Sufficient venous access for leukapheresis collection and no other contraindications
to leukapheresis;
10. 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;
11. subjects must have signed writtern informed consent.
Exclusion Criteria:
1. 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;
2. 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;
3. Convulsion or stoke within past 6 months;
4. 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);
5. Patients have central nervous system(CNS) metastases or CNS involvement(including
cranial neuropathies or mass lesions and leptomeningeal disease);
6. 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;
7. Presence or suspicious of fungi, bacteria, viruses or other infections that are
uncontrollable or requiring intravenous treatment;
8. Activity of autoimmune disease (such as crohn's disease, rheumatoid arthritis,
systemic lupus erythematosus), orhistory of autoimmune disease within the last 3
years;
9. Clinical evidence of dementia or changes of mental state;
10. Exist of pulmonary fibrosis;
11. Allergy subjects or history of severe hypersensitivity;
12. Oxgen inhalation requirement to maintain adequate oxygen saturation;
13. Surgery (except for local anesthesia surgery) plan 2 weeks before apheresis, during or
2 weeks after CAR-T infusion;
14. Patients who are accounted to be not appropriate for this investigator.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence and severity of adverse events after GC012F injection |
Time Frame: | Minimum 2 years after GC012F infusion |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Percentage of MRD negative patients after GC012F infusion |
Time Frame: | Minimum 2 years after GC012F infusion |
Safety Issue: | |
Description: | |
Measure: | ORR(PR, VGPR, CR and sCR) of patients after GC012F treatment |
Time Frame: | Minimum 2 years after GC012F infusion(Day0) |
Safety Issue: | |
Description: | percent of subjects who achieving PR or better after GC012F infusion |
Measure: | Progression free survival after GC012F treatment |
Time Frame: | Minimum 2 years after GC012F infusion(Day0) |
Safety Issue: | |
Description: | |
Measure: | Duration of response of subjects after GC012F treatment |
Time Frame: | Minimum 2 years after GC012F infusion(Day0) |
Safety Issue: | |
Description: | |
Measure: | Overall survivalof subjects after GC012F treatment |
Time Frame: | Minimum 2 years after GC012F infusion(Day0) |
Safety Issue: | |
Description: | |
Measure: | Cytokines in serum after GC012F infusion |
Time Frame: | Minimum 24 weeks after GC012F infusion(Day0) |
Safety Issue: | |
Description: | |
Measure: | Subset of lymphocytes in blood after GC012F infusion |
Time Frame: | Minimum 2 years after GC012F infusion(Day0) |
Safety Issue: | |
Description: | |
Measure: | Anti-GC012F antibodies in blood after GC012F infusion |
Time Frame: | Minimum 2 years after GC012F infusion(Day0) |
Safety Issue: | |
Description: | |
Measure: | Cell counts of GC012F in blood and bone marrow(if available) after GC012F infusion |
Time Frame: | Minimum 2 years after GC012F infusion(Day0) |
Safety Issue: | |
Description: | |
Measure: | Copies of GC012F in blood and bone marrow(if available) after GC012F infusion |
Time Frame: | Minimum 2 years after GC012F infusion(Day0) |
Safety Issue: | |
Description: | |
Details
Phase: | Early Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Shanghai Changzheng Hospital |
Trial Keywords
- high-risk
- Fast
- Chimeric Antigen Receptor T
- BCMA
- CD19
- Multiple Myeloma
Last Updated
November 5, 2020