BCMA CAR-T Cell Injection (CT103A)
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
What will happen during the trial?
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 Subjects except those that are deceased, lost to follow-up, or have withdrawn their ICF will enter the long-term follow-up (LTFU) under a separate protocol for at least 15 years.
More Information
- Trial Status
- Not yet accepting
- Trial Phase
- Phase 1
- Enrollment
- 12 patients (estimated)
- Sponsors
- Nanjing IASO Biotherapeutics Co.,Ltd
- Tags
- CAR T Cell, B-Cell Maturation Antigen (BCMA)
- Trial Type
- Treatment
- Last Update
- SparkCures ID
- 1353
- NCT Identifier
- NCT05698303
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