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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
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.
Minimum Age: 14 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hainan Hospital of Chinese PLA General Hospital, Sanya, Hainan, China
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