BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma

STATUS

Recruiting
participants needed

80
sponsor

Chongqing Precision Biotech Co., Ltd

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Updated on 19 February 2024

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remission

renal function

chemotherapy regimen

ejection fraction

stem cell transplantation

cell transplantation

multiple myeloma

mental disorders

oxygen saturation

refractory multiple myeloma

cellular therapy

t cell therapy

bcma

cells therapy

Summary

This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.

Description

There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

Details

Condition	Plasma Cell Neoplasm, Multiple Myeloma, Multiple Myeloma, Lymphoproliferative Disorder, Multiple Myeloma in Relapse
Age	18years - 75years
Treatment	BCMA CAR-T cells
Clinical Study Identifier	NCT04271644
Sponsor	Chongqing Precision Biotech Co., Ltd
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Signed written informed consent
	Diagnose as relapsed /refractory multiple myeloma, and meet one of the following
	conditions
	Failed to standard chemotherapy regimens
	Relapse after complete remission, high-risk and / or refractory patients
	Relapse after hematopoietic stem cell transplantation
	Evidence for cell membrane BCMA expression
	All genders, ages: 18 to 75 years
	The expect time of survive is above 3 months
	KPS60
	No serious mental disorders
	Left ventricular ejection fraction 50%
	Sufficient hepatic function defined by ALT/AST3 x ULN and bilirubin2 x ULN
	Sufficient renal function defined by creatinine clearance2 x ULN
	Sufficient pulmonary function defined by indoor oxygen saturation92%
	With single or venous blood collection standards, and no other cell collection contraindications
	Ability and willingness to adhere to the study visit schedule and all protocol requirements
Exclusion Criteria
	Previous history of other malignancy
	Presence of uncontrolled active infection
	Evidence of disorder that need the treatment by glucocorticoids
	Active or chronic GVHD
	The patients treatment by inhibitor of T cell
	Pregnant or breasting-feeding women
	Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis

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Step 2 Get screened

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Step 3 Enroll in the clinical study

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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Step 4 Get your study results

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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Study Definition

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BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma