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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: NCT04322292
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
AnGang, Institute of Hematology & Blood Diseases Hospital

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
Multiple Myeloma Drug: 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
Allocation: N/A
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
Actual Study Start Date : September 12, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : November 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.
Drug: 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.

Divided into three dose ranges of low(1.0-3.0×10^6 CAR+T cells/kg),medium(3.0-6.0×10^6 CAR+T cells/kg) and high(6.0-9.0×10^6 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 ]
    ORR(including sCR / CR / VGPR / PR, based on IMWG 2016 efficacy evaluation criteria)

  2. Progression free survival (PFS) [ Time Frame: 6 months、12 months ]
    PFS(based on IMWG 2016 efficacy evaluation criteria)

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

Inclusion Criteria:

  1. Age 18-75 years old, male or female;
  2. The patient volunteered to participate in the study, and he or his legal guardian signed the Informed Consent;
  3. Meet the internationally accepted Criteria for the diagnosis of multiple myeloma (IMWG diagnostic criteria 2014);
  4. Patients with a clear diagnosis of relapsed or refractory multiple myeloma who have received at least 3 lines of MM (Contains proteasome inhibitors and immunomodulatory therapies that progress or relapse during the most recent treatment or after the end of treatment). Note: The planned treatment plan for one or more cycles is "one-line treatment"; induction chemotherapy, stem cell transplantation, and maintenance treatment (if there is no disease progression between them), it is considered as a one-line treatment plan;
  5. The patient have one or more measurable multiple myeloma lesion, must include one of the following conditions:

    • Serum M protein≥1.0 g/dL(10g/L)
    • Urine M protein≥200 mg/24h
    • Serum free light chain(sFLC): κ/λ FLC ratio is abnormal and affected FLC ≥10mg / dL
  6. Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination;
  7. ECOG scores 0 - 1;
  8. Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) ≥50%, and no severe arrhythmia;
  9. No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
  10. Absolute neutrophil count ≥1.0 × 109 / L, platelet count ≥50 × 109 / L; total serum bilirubin ≤1.5mg / dl; serum ALT or AST less than 2.5 times the upper limit of normal; serum creatinine ≤2.0mg / dl;
  11. No contraindications of peripheral blood apheresis;
  12. Expected survival time > 12 weeks;.
  13. Female subjects of childbearing age must have a negative urine / blood pregnancy test within 7 days before cell therapy and not be in lactation; female or male subjects of childbearing age need to take effective contraception throughout the study.

Exclusion Criteria:

  1. Have a history of allergy to cell ular products;
  2. Presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any heart function Grade 3 (moderate) or Grade 4 (severe) heart disease (according to the New York Heart Association Function Classification method: NYHA); patients with a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris or other clinically significant heart disease within 12 months before enrollment;
  3. A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease;
  4. Need to use any anticoagulant (except aspirin);
  5. Patients requiring urgent treatment due to tumor progression or spinal cord compression;
  6. Patients with CNS metastasis or symptoms of CNS involvement;
  7. After allogeneic hematopoietic stem cell transplantation;
  8. Plasma cell leukemia;
  9. Received systemic anti-tumor treatment within 2 weeks before apheresis, and within 1 week before apheresis, prednisone (or equivalent amount of other corticosteroids) was applied in excess of 5 mg/d ;
  10. Patients with autoimmune diseases, immunodeficiency, or other immunosuppressive agents;
  11. Uncontrolled active infection;
  12. Have used any CAR T cell products or other genetically modified T cell therapy before;
  13. Live vaccination within 4 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 1 months;
  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): NCT04322292


Contacts
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Contact: Gang An, PhD&MD 008613502181109 angang@ihcams.ac.cn

Locations
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China
InstituteHBDH Recruiting
TianJin, China, 300000
Contact: Gang An, PhD&MD    +008613502181109    angang@ihcams.ac.cn   
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital

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Responsible Party: AnGang, Deputy Chief Physician, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT04322292    
Other Study ID Numbers: QT-2019007-EC-2
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 AnGang, Institute of Hematology & Blood Diseases Hospital:
Multiple Myeloma
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