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Trial record 1 of 1 for:    04447573
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Immunotherapy With BCMA CAR-T Cells in Treating Patients With Relapsed or Refractory 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: NCT04447573
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : September 29, 2020
Sponsor:
Collaborators:
Beijing Lu Daopei Hospital
Hebei Yanda Ludaopei Hospital
Information provided by (Responsible Party):
Hebei Senlang Biotechnology Inc., Ltd.

Brief Summary:
This study is aimed to evaluate the safety, feasibility and efficacy of BCMA CAR-T in the treatment of relapsed or refractory multiple myeloma

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: BCMA CAR-T Not Applicable

Detailed Description:

This is a study to evaluate the safety, feasibility and efficacy of BCMA CAR-T in the treatment of relapsed or refractory multiple myeloma.

The Main research objectives:

To evaluate the safety and efficacy of BCMA CAR-T in patients with relapsed or refractory multiple myeloma

The Secondary research objectives:

To investigate the cytokinetic characteristics of BCMA CAR-T in patients with relapsed or refractory multiple myeloma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunotherapy With BCMA CAR-T Cells in Treating Patients With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : June 30, 2020
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: BCMA CAR-T cells
Patients will be treated with BCMA CAR-T cells
Biological: BCMA CAR-T
Biological: BCMA CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;




Primary Outcome Measures :
  1. Safety: Incidence and severity of adverse events [ Time Frame: First month post CAR-T cells infusion ]
    To evaluate the possible adverse events occurred within first one month after BCMA CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

  2. Efficacy: Overall Remission Rate (ORR) [ Time Frame: 3 months post CAR-T cells infusion ]
    Overall Remission Rate (ORR) including partial remission and complete


Secondary Outcome Measures :
  1. Efficacy:duration of response (DOR) [ Time Frame: 24 months post CAR-T cells infusion ]
    duration of response (DOR)

  2. Efficacy: progression-free survival (PFS) [ Time Frame: 24 months post CAR-T cells infusion ]
    progression-free survival (PFS) time

  3. CAR-T proliferation [ Time Frame: 3 months post CAR-T cells infusion ]
    the copy number of BCMA CAR- T cells in the genomes of PBMC by qPCR method and percentage of BCMA CAR- T cells measured by flow cytometry method

  4. Cytokine release [ Time Frame: First month post CAR-T cells infusion ]
    Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method



Information from the National Library of Medicine

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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. The subjects voluntarily participated in the study and signed the informed consent form by themselves or their legal guardian;
  2. According to the international standard for multiple myeloma (IMWG 2014);
  3. Diagnosed as relapsed or refractory multiple myeloma. Relapsed and refractory were defined as follow. Relapsed: patients had received for at least 3 drugs with different mechanisms of action (including protease inhibitors and immunomodulators) and disease progression within 60 days of the most recent treatment. Refractory was defined as: disease progression occurred during the recent treatment, or disease progression occurred within 60 days after treatment;
  4. The expression of BCMA in myeloma cells was reported as positive by flow cytometry or immunohistochemistry;
  5. No antibody drug was administered within last 2 weeks before cell therapy;
  6. ECOG Scores: 0~1
  7. Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) ≥ 50%, no serious arrhythmia;
  8. The subjects had no pulmonary infection, normal pulmonary function, and indoor air oxygen saturation ≥ 92%;
  9. There was no contraindication for peripheral blood sampling;
  10. The estimated survival time was more than 12 weeks;
  11. The urine pregnancy test of female subjects of childbearing age should be negative and not in lactation; the female or male subjects of childbearing age should take effective contraceptive measures during the whole research process.

Exclusion Criteria:

  1. Have a history of allergy to any component of cell products;
  2. There are clinically significant cardiovascular diseases, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any grade 3 (moderate) or grade 4 (severe) heart disease with cardiac function (according to the functional classification method of the New York Heart AssociationNYHA) with a history of myocardial infarction, angioplasty or stent implantation, unstable angina or other clinically significant heart disease within 12 months before admission;
  3. who has suffered from brain injury, consciousness disorder, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
  4. Patients who need urgent treatment due to tumor progression or spinal cord compression;
  5. The investigator determines that there are serious complications or diseases that will increase the risk of the subject or affect the study, including but not limited to, for example, cirrhosis, recent major trauma, etc;
  6. After allogeneic hematopoietic stem cell transplantation;
  7. Patients with autoimmune diseases, immunodeficiency or other diseases requiring immunosuppressive (excluding glucocorticoid)therapy;
  8. There was uncontrolled active infection;
  9. There were live vaccinations within 4 weeks before admission;
  10. Active hepatitis (positive for HBVDNA or HCVRNA), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to those with HIV infection;
  11. Subjects had a history of alcohol, drug or mental illness;
  12. The researchers believe that there are other conditions that subjects are not suitable to participate in this study.

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): NCT04447573


Contacts
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Contact: Peihua Lu, PhD&MD 008618611636172 peihua_lu@126.com
Contact: Jianqiang Li, PhD&MD 008615511369555 limmune@gmail.com

Locations
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China, Hebei
He bei Yan da Lu dao pei Hospital Recruiting
Yanda, Hebei, China
Contact: Peihua Lu, MD/PhD         
China, Yizhuang
BeiJing Ludaopei Hospital Recruiting
Beijing, Yizhuang, China, 100000
Contact: Peihua Lu, PhD&MD    008618611636172    peihua_lu@126.com   
Principal Investigator: Peihua Lu, PhD&MD         
Sub-Investigator: Jianqiang Li, PhD&MD         
Sponsors and Collaborators
Hebei Senlang Biotechnology Inc., Ltd.
Beijing Lu Daopei Hospital
Hebei Yanda Ludaopei Hospital
Investigators
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Principal Investigator: Peihua Lu, PhD&MD Beijing Lu Daopei Hospital
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Responsible Party: Hebei Senlang Biotechnology Inc., Ltd.
ClinicalTrials.gov Identifier: NCT04447573    
Other Study ID Numbers: BCMA CAR-T
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: August 2020

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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 Hebei Senlang Biotechnology Inc., Ltd.:
BCMA,MM
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