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Spots Global Cancer Trial Database for Safety and Efficiency Study of BCMA-PD1-CART Cells in Relapsed/Refractory Multiple Myeloma

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Trial Identification

Brief Title: Safety and Efficiency Study of BCMA-PD1-CART Cells in Relapsed/Refractory Multiple Myeloma

Official Title: Safety and Efficiency Study of BCMA-PD1-CART Cells in Relapsed/Refractory Multiple Myeloma

Study ID: NCT04162119

Interventions

BCMA-PD1-CART Cell

Study Description

Brief Summary: This is a single center, non-randomized, open-label, phase 2 study to evaluate the efficacy and safety of BCMA-PD1-CART cells therapy for patients with relapsed/refractory Multiple Myeloma.

Detailed Description: Previous studies have found that multiple myeloma cells express PD-L1 at a high level. Therefore, the combination of anti-PD-1 or PD-L1 antibodies with CART therapy may further improve the clinical efficacy of CART cell for multiple myeloma. The investigators screened PD-1 mutant that have high affinity bind with the PD-L1 ligand, and the affinity of the prepared mutant PD-1 Fc fusion protein to bind to PD-L1 reached clinical anti-PD-L1 antibody levels. The investigators prepared BCMA CART cells which secretes the mutant PD-1Fc fusion protein, and the prepared CART cell culture supernatant can well block the binding of PD-L1 to PD-1. Preclinical studies have shown that BCMA CART cells secreting mutant PD-1Fc fusion protein have a superior killing effect on PD-L1 positive multiple myeloma tumor cells to BCMA CART cells which does not express PD-1 fusion protein. The trial was conducted to explore the safety and efficacy of BCMA-PD1-CART cells in Relapsed/Refractory Multiple Myeloma.

Eligibility

Minimum Age: 14 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hainan Hospital of Chinese PLA General Hospital, Sanya, Hainan, China

Contact Details

Name: Quanshun Wang

Affiliation: Hainan Hospital of Chinese PLA General Hospital

Role: STUDY_CHAIR

Name: Wenshuai Zheng

Affiliation: Hainan Hospital of Chinese PLA General Hospital

Role: STUDY_DIRECTOR

Name: Lixun Guan

Affiliation: Hainan Hospital of Chinese PLA General Hospital

Role: STUDY_DIRECTOR

Name: Lu Wang

Affiliation: Hainan Hospital of Chinese PLA General Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: Yuanyuan Xu

Affiliation: Hainan Hospital of Chinese PLA General Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: Zhenyang Guan

Affiliation: Hainan Hospital of Chinese PLA General Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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