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

  • STATUS
    Recruiting
  • End date
    Jul 1, 2023
  • participants needed
    80
  • sponsor
    Chongqing Precision Biotech Co., Ltd
Updated on 14 March 2021
renal function
remission
stem cell transplantation
ejection fraction
cell transplantation
chemotherapy regimen
mental disorders
refractory multiple myeloma
bcma

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, Lymphoproliferative Disorder, Multiple Myeloma in Relapse, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment BCMA CAR-T Cells
Clinical Study IdentifierNCT04271644
SponsorChongqing Precision Biotech Co., Ltd
Last Modified on14 March 2021

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
KPS>60
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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What happens next?
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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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