Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT05698303
Brief 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.
Detailed 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 Subjects except those that are deceased, lost to follow-up, or have withdrawn their ICF will enter the long-term follow-up (LTFU) under a separate protocol for at least 15 years.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:
NCT05698303
Study Brief:
Protocol Section:
NCT05698303