Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT05698303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-26
First Post:
2022-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (CT103A) in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
Sponsor:
Nanjing IASO Biotechnology Co., Ltd.
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Subjects except those that are deceased, lost to follow-up, or have withdrawn their ICF will enter the long-term follow-up (LTFU) under a separate protocol for at least 15 years.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: