Multiple Myeloma Clinical Trial
Official title:
Safety and Efficiency Study of BCMA-PD1-CART Cells in Relapsed/Refractory Multiple Myeloma
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.
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.
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