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

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Recruiting
participants needed

20
sponsor

Hebei Senlang Biotechnology Inc., Ltd.

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Updated on 19 February 2024

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ejection fraction

multiple myeloma

flow cytometry

immunohistochemistry

oxygen saturation

immunomodulators

arrhythmia

refractory multiple myeloma

cellular therapy

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
Age	18-70 years
Treatment	BCMA CAR-T
Clinical Study Identifier	NCT04447573
Sponsor	Hebei Senlang Biotechnology Inc., Ltd.
Last Modified on	19 February 2024

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