Multiple Myeloma Clinical Trial
Official title:
A Phase Ib Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (CT103A) in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
It is a dose expansion, open-label, phase Ib study to evaluate the safety, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of CT103A in patients with relapsed/refractory multiple myeloma.
A total of at least 12 subjects are planned to be enrolled in this study. Each subject will proceed through the following study periods: - Screening - Leukapheresis - Bridging therapy (at the discretion of the investigator) - Pre-lymphodepletion assessment - Lymphodepleting chemotherapy - Pre-infusion Assessment - CT103A infusion (Day 0) - 28-Day safety evaluation period - Post-treatment follow-up period (Day 29 through year 2) All the subjects will be followed for safety and efficacy until disease progression, initiation of subsequent anti-myeloma therapy, withdrawal, death, loss to follow-up, study completion, end of study, or study termination, whichever occurs first. Subjects except those that are deceased, lost to follow-up, or have withdrawn their ICF will enter the long-term follow-up (LTFU) under a separate protocol for at least 15 years. ;
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