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A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03815383
Recruitment Status : Not yet recruiting
First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
This is a single-center, non-randomized and dose-escalation 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), CCAR088 infusion and Follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 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 : February 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : April 2021

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 by a single infusion intravenously will be given in escalating doses.
Other Name: CBM.BCMA Chimeric Antigen Receptor T cell




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


Secondary Outcome Measures :
  1. ORR [ Time Frame: 12 months ]
    Overall response rate

  2. PFS [ Time Frame: 6 months, 12 months ]
    Progression free survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 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 18-75 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.
  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 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 active CNS involvement or clinical syndrome of MM meningeal involvement.
  8. After allogeneic hematopoietic stem cell transplantation.
  9. Plasma cell leukemia.
  10. Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy.
  11. Uncontrolled active infection.
  12. Prior treatment with CAR T therapy or any other genetically modified T cell therapy.
  13. Live vaccine inoculation within four weeks before enrollment.
  14. 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.
  15. Have a history of alcoholism, drug addiction and mental illness.
  16. Participated in any other clinical trial within one month.
  17. 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): NCT03815383


Contacts
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Contact: Jianyong Li, PhD 025-83718836,83714511 lijianyonglm@126.com

Locations
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China, Jiangsu
the First Affiliated Hospital of Nanjing Medical University Not yet recruiting
Nanjing, Jiangsu, China, 210000
Contact: Jianyong Li, PhD       lijianyonglm@126.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University

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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03815383     History of Changes
Other Study ID Numbers: 0203-008
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: December 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