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Multiple Myeloma

Neoplasms, Plasma Cell

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Patients will be be treated with BCMA targeted prime CAR-T cells

BCMA targeted prime CAR-T cells

Zhi Yang, PhD

Sanbin Wang, MD

Cheng Qian, PhD

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

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 prime 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.

a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma

Study Evaluating Safety and Efficacy of BCMA-Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory Multiple Myeloma

Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

The response rate of BCMA targeted prime CAR-T treatment will be recorded and assessed according to the IMWG

In vivo (bone marrow and peripheral blood) rate of BCMA targeted prime CAR-T cells were determined by means of flow cytometry

In vivo (bone marrow and peripheral blood) quantity of BCMA targeted prime CAR copies were determined by means of qPCR

In vivo (bone marrow) quantity of clonal plasma cells

DOR will be assessed from the first assessment of sCR/CR/VGPR/PR to the first assessment of recurrence or progression of the disease or death from any cause (censored)

PFS will be assessed from the first prime CAR-T cell infusion to death from any cause or the first assessment of progression (censored)

OS will be assessed from the first prime CAR-T cell infusion to death from any cause (censored)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma	NCT04776330	Multiple Myelom... Neoplasm, Plasm... Multiple Myelom...	BCMA targeted p...	18 Years - 75 Years	Chongqing Precision Biotech Co., Ltd
a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma	NCT04776330	Multiple Myelom... Neoplasm, Plasm... Multiple Myelom...	BCMA targeted p...	18 Years - 75 Years	Chongqing Precision Biotech Co., Ltd

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