Nanjing IASO Biotechnology Co., Ltd.
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.
Multiple Myeloma
Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A)
Phase 1
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 Subjects except those that are deceased, lost to follow-up, or have withdrawn their ICF will enter the long-term follow-up (LTFU) under a separate protocol for at least 15 years.}}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 Type : | Interventional |
Estimated Enrollment : | 12 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
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 |
Actual Study Start Date : | May 8, 2023 |
Estimated Primary Completion Date : | May 20, 2024 |
Estimated Study Completion Date : | January 15, 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: CT103A in patients with RRMM After lymphodepletion, CT103A will be administered as a single infusion. |
Drug: Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A) |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030