A Multi-center Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T (CAR-T) Cell Injection (CT103A) in the Treatment of Newly Diagnosed Subjects With High-risk Multiple Myeloma (FUMANBA-2)

NCT05181501 Phase 1 NOT_YET_RECRUITING

This study is a multi-center, single-arm clinical study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamic characteristics of CT103A as the first-line treatment in newly diagnosed high-risk multiple myeloma subjects with induction chemotherapy as bridging therapy.

Details

Lead sponsor	Nanjing IASO Biotechnology Co., Ltd.
Phase	Phase 1
Status	NOT_YET_RECRUITING
Enrolment	20
Start date	2022-04
Completion	2039-04

Conditions

• Multiple Myeloma

Interventions

• Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A)

Primary outcomes

• Proportion of Minimal Residual Disease (MRD)-negative subjects — Up to 2 years after CT103A infusion
  The proportion of subjects who achieve MRD-negativity after CT103A infusion.
• Median progression-free survival (mPFS) — Up to 2 years after CT103A infusion
  The median time from the date of CT103A infusion to the date of first disease progression or death from any cause.

Countries

China