Immunotherapy With BCMA CAR-T Cells in Treating Patients With Relapsed or Refractory Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    20
  • sponsor
    Hebei Senlang Biotechnology Inc., Ltd.
Updated on 25 January 2021
fludarabine
ejection fraction
immunohistochemistry
refractory multiple myeloma
bcma

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

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.

Details
Condition Multiple Myeloma, Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment BCMA CAR-T
Clinical Study IdentifierNCT04447573
SponsorHebei Senlang Biotechnology Inc., Ltd.
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

The subjects voluntarily participated in the study and signed the informed consent form by themselves or their legal guardian
According to the international standard for multiple myeloma (IMWG 2014)
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
The expression of BCMA in myeloma cells was reported as positive by flow cytometry or immunohistochemistry
No antibody drug was administered within last 2 weeks before cell therapy
ECOG Scores: 0~1
Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) 50%, no serious arrhythmia
The subjects had no pulmonary infection, normal pulmonary function, and indoor air oxygen saturation 92%
There was no contraindication for peripheral blood sampling
The estimated survival time was more than 12 weeks
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

Have a history of allergy to any component of cell products
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
who has suffered from brain injury, consciousness disorder, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease
Patients who need urgent treatment due to tumor progression or spinal cord compression
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
After allogeneic hematopoietic stem cell transplantation
Patients with autoimmune diseases, immunodeficiency or other diseases requiring immunosuppressive excluding glucocorticoidtherapy
There was uncontrolled active infection
There were live vaccinations within 4 weeks before admission
Active hepatitis (positive for HBVDNA or HCVRNA), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to those with HIV infection
Subjects had a history of alcohol, drug or mental illness
The researchers believe that there are other conditions that subjects are not suitable to participate in this study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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