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Clinical Trial Summary

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.


Clinical Trial Description

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 Subjects except those that are deceased, lost to follow-up, or have withdrawn their ICF will enter the long-term follow-up (LTFU) under a separate protocol for at least 15 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05698303
Study type Interventional
Source Nanjing IASO Biotherapeutics Co.,Ltd
Contact Robert Z. Orlowski, M.D., Ph.D.
Phone 713-792-2860
Email rorlowsk@mdanderson.org
Status Not yet recruiting
Phase Phase 1
Start date May 8, 2023
Completion date January 15, 2026

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