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BCMA and CD19 Targeted Fast Dual CAR-T for BCMA+ Refractory/Relapsed Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04236011
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : February 11, 2020
Gracell Biotechnology Shanghai Co., Ltd.
Information provided by (Responsible Party):
Weijun Fu, Shanghai Changzheng Hospital

Brief 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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: GC012F injection Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploratory Study to Evaluate Efficacy and Safety of GC012F Injection in BCMA+ Refractory/Relapsed Multiple Myeloma
Actual Study Start Date : January 16, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: GC012F treatment
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.
Biological: GC012F injection
GC012F injection is a autologous dual CAR-T targeted BCMA and CD19. A single infusion of CART cells will be administered intravenously.

Primary Outcome Measures :
  1. Incidence and severity of adverse events after GC012F infusion [ Time Frame: up to 24 weeks after GC012F infusion ]

Secondary Outcome Measures :
  1. Percentage of MRD negative patients after GC012F treatment [ Time Frame: 12 weeks, 24 weeks after GC012F infusion ]
  2. ORR (PR, VGPR, CR and sCR) of patients receive GC012F treatment [ Time Frame: 12 weeks, 24 weeks after GC012F infusion ]
  3. Progression free survival after GC012F treatment [ Time Frame: 12 weeks, 24 weeks after GC012F infusion ]
  4. 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 ]
    Bone marrows will be collected in weeks 4, 8, 12, 18, 24 after GC012F infusion.

  5. Cytokines in serum after GC012F treatment [ Time Frame: Days 4, 7, 10, 14 and weeks 4, 8, 12, 18, 24 after GC012F infusion ]
  6. Subset of lymphocytes and ADA in blood after GC012F treatment [ Time Frame: Weeks 4, 8, 12, 18, 24 after GC012F infusion ]
  7. Replication competent lentivirus (RCL) in blood after GC012F treatment [ Time Frame: Weeks 4, 12, 24 after GC012F infusion ]
  8. Duration of response after GC012F treatment [ Time Frame: 12 weeks, 24 weeks after GC012F infusion ]
  9. Overall survival after GC012F treatment [ Time Frame: 12 weeks, 24 weeks after GC012F infusion ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients must have a confirmed prior diagnosis of active multiple myeloma as defined by the updated IMWG criteria;
  2. Patients with clear BCMA expression(percent of BCMA positive plasma cells ≥20%) detected by flow cytometry;
  3. Diagnosis of MM with relapsed or refractory disease. Definition of Refractory/relapse: a)Have had at least 2 different prior lines of therapy and undergone at least have at least complete 1 cycle treatment in each line, unless the best response was PD. Note: Induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single line of therapy; Participant must have documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria on or within 12 months of their last line of therapy; b)Refractory to both immunomodulatory drug (IMiD) and proteasome inhibitor(PI); c)Relapse criteria in NCCN clinical practice guidelines in Oncology: Multiple Myeloma (2016);
  4. Estimated life expectancy ≥3 months;
  5. Hemoglobin ≥ 8.0 g/dL;
  6. Absolute neutrophil count ≥ 0.75*10E9/L;
  7. Platelet count ≥ 25*10E9/L;
  8. Absolute lymphocyte count ≥ 1*10E8/L;
  9. 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)Serum creatinine ≤ 1.5×ULN, maintenance of kidney function not depend on dialysis; c)Corrected serum calcium ≤ 12.5mg/dL or free ion calcium ≤ 6.5mg/dL(1.6mmol/L);
  10. Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis;
  11. 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;
  12. Subjects must have signed written, informed consent.

Exclusion Criteria:

  1. 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;
  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 interests (e.g., 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 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 );
  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 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;
  7. Presence or suspicion of fungi, bacteria, viruses or other infections that are uncontrollable or requiring intravenous treatment;
  8. Activity of autoimmune diseases (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. Oxygen inhalation requirment to maintain adequate oxygen saturation;
  13. Surgery (except for local anesthesia surgery) plan 2 weeks before apheresis. during or 2 weeks after CART infusion;
  14. Chemotherapy forbidden for cyclophosphamide or fludarabine;
  15. Pregnant or lactating, or planning to have a pregnancy during or within 100 days after treatment;
  16. Patients who are accounted to be not appropriate for this trail by investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04236011

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Contact: Weijun Fu (+86)13816052522

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China, Shanghai
Shanghai Changzheng Hospital Recruiting
Shanghai, Shanghai, China
Contact: Weijun Fu         
Sponsors and Collaborators
Shanghai Changzheng Hospital
Gracell Biotechnology Shanghai Co., Ltd.
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Responsible Party: Weijun Fu, Director of Hematology Department, Shanghai Changzheng Hospital Identifier: NCT04236011    
Other Study ID Numbers: GBF002
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weijun Fu, Shanghai Changzheng Hospital:
Chimeric Antigen Receptor T
Multiple Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases