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A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r 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.
 
ClinicalTrials.gov Identifier: NCT03751293
Recruitment Status : Recruiting
First Posted : November 23, 2018
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hebei Yanda Ludaopei Hospital

Tracking Information
First Submitted Date  ICMJE November 15, 2018
First Posted Date  ICMJE November 23, 2018
Last Update Posted Date May 15, 2019
Actual Study Start Date  ICMJE January 8, 2019
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
Safety: The incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: 30 days ]
The incidence of treatment-emergent adverse events (TEAEs)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
  • Overall response rate (ORR) [ Time Frame: 12 months ]
  • Progression free survival (PFS) [ Time Frame: 6 months, 12 months ]
  • The CART cell duration in vivo [ Time Frame: 12 months ]
    The copys of BCMA-CART DNA in peripheral blood with qPCR method
  • The soluble BCMA changes in peripheral blood [ Time Frame: 12 months ]
    The amount of soluble BCMA in peripheral blood with ELISA method
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma
Official Title  ICMJE A Phase Ⅰ Study Evaluating Safety and Efficacy of C-CAR088 Treatment in Subjects With Relapsed or Refractory Multiple Myeloma
Brief Summary This is a single-center, non-randomized study to evaluate the safety and efficacy of C-CAR088 in relapsed or refractory multiple myeloma patient.
Detailed Description The study will include the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed or Refractory Multiple Myeloma
Intervention  ICMJE Biological: C-CAR088
Autologous BCMA-directed CAR-T cells, single infusion intravenously at a target dose of 1.0-9.0 x 10^6 anti-BCMA CAR+ T cells/kg
Other Name: CBM.BCMA Chimeric Antigen Receptor T cell
Study Arms  ICMJE Experimental: C-CAR088
Lymphocytes will be transduced with lentiviral vector containing CAR-BCMA gene
Intervention: Biological: C-CAR088
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 20, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2020
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Volunteered to participate in this study and signed informed consent.
  2. Age 18-70 years old, male or female.
  3. Meet the internationally accepted Criteria for the diagnosis of multiple myeloma (IMWG diagnostic criteria 2014).
  4. Patients with relapsed or refractory multiple myeloma who meet at least one of the following conditions:

    • Subjects must have received at least two therapy regimens (including proteasome inhibitor or immune-modulator therapy, disease progress or relapse after the last therapy).
    • Subjects have received only one therapy regimen, but the investigators judge that patients have unmet treatment needs or can't get benefit from current treatment options.
  5. Subjects have one or more measurable multiple myeloma lesion, must include one of the following conditions:

    • Serum M protein≥1 g/dl(10g/L)
    • Urine M protein≥200 mg/24h
    • Serum free light chain(sFLC): κ/λ ratio abnormal and ≥10 mg/dl
  6. Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination.
  7. At least 2 weeks from monoclonal antibody therapy prior to CAR T cell therapy.
  8. ECOG scores 0 - 1.
  9. Normal cardiac diastolic function, left ventricular ejection fraction (LVEF) ≥ 50% (detected by echocardiography), no serious arrhythmia.
  10. No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
  11. No contraindications of leukapheresis.
  12. Expected survival > 12 weeks.
  13. Female subjects in childbearing age, their serum or urine pregnancy test must be negative,until 7 days before cell therapy and all subjects must agree to take effective contraceptive measures during the trial.

Exclusion Criteria:

  1. Have a history of allergy to cellular products.
  2. Any kind of these laboratory testing: including but not limited to,serum total bilirubin≧1.5mg/dl, serum ALT, AST≧2.5×ULN, serum creatinine≧2.0mg/dl, Hb (hemoglobin)<80g/L, neutrophils<1000/mm^3, platelets≦50000/mm^3 or platelet count maintained by transfusion.
  3. Subjects with the following clinically significant cardiovascular diseases.
  4. A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease.
  5. Use any anticoagulant (except aspirin).
  6. Patients requiring urgent treatment due to tumor progression or spinal cord compression.
  7. Patients with CNS metastasis or symptoms of CNS involvement.
  8. The investigators judge that any increase in the risk of the subject or interference with the results of the trial.
  9. After allogeneic hematopoietic stem cell transplantation.
  10. Plasma cell leukemia.
  11. One week before leukapheresis and one week before CART cell infusion, treated with more than 5mg/d prednisone (or equal amount of other corticosteroids).
  12. Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy.
  13. Uncontrolled active infection.
  14. Prior treatment with CAR T therapy or any other genetically modified T cell therapy.
  15. Live vaccine inoculation within four weeks before enrollment.
  16. Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons.
  17. Have a history of alcoholism, drug addiction and mental illness.
  18. Participated in any other clinical trial within three months.
  19. The investigators believe that there are other circumstances that are not suitable for the trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peihua Lu, PhD&MD +86-0316-3306393 peihua_lu@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03751293
Other Study ID Numbers  ICMJE 0203-006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hebei Yanda Ludaopei Hospital
Study Sponsor  ICMJE Hebei Yanda Ludaopei Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hebei Yanda Ludaopei Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP