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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 : Not yet recruiting
First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Hebei Yanda Ludaopei Hospital

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.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Multiple Myeloma Biological: C-CAR088 Phase 1

Detailed Description:
The study will include the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ⅰ Study Evaluating Safety and Efficacy of C-CAR088 Treatment in Subjects With Relapsed or Refractory Multiple Myeloma
Estimated Study Start Date : November 30, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: C-CAR088
Lymphocytes will be transduced with lentiviral vector containing CAR-BCMA gene
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




Primary Outcome Measures :
  1. Safety: The incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: 30 days ]
    The incidence of treatment-emergent adverse events (TEAEs)


Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 12 months ]
  2. Progression free survival (PFS) [ Time Frame: 6 months, 12 months ]
  3. The CART cell duration in vivo [ Time Frame: 12 months ]
    The copys of BCMA-CART DNA in peripheral blood with qPCR method

  4. The soluble BCMA changes in peripheral blood [ Time Frame: 12 months ]
    The amount of soluble BCMA in peripheral blood with ELISA method



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 to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 4 weeks from receiving remedial chemotherapy prior to leukapheresis.
  8. At least 2 weeks from monoclonal antibody therapy prior to CAR T cell therapy.
  9. ECOG scores 0 - 1.
  10. Normal cardiac diastolic function, left ventricular ejection fraction (LVEF) ≥ 50% (detected by echocardiography), no serious arrhythmia.
  11. No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
  12. No contraindications of leukapheresis.
  13. Expected survival > 12 weeks.
  14. 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. Two weeks before leukapheresis and two weeks 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.

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 ClinicalTrials.gov identifier (NCT number): NCT03751293


Contacts
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Contact: Peihua Lu, PhD&MD +86-0316-3306393 peihua_lu@126.com

Locations
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China, Hebei
Hebei Yanda Ludaopei Hospital Not yet recruiting
Sanhe, Hebei, China, 065200
Contact: Peihua Lu, PhD&MD    +86-0316-3306393      
Sponsors and Collaborators
Hebei Yanda Ludaopei Hospital

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Responsible Party: Hebei Yanda Ludaopei Hospital
ClinicalTrials.gov Identifier: NCT03751293     History of Changes
Other Study ID Numbers: 0203-001
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases