drugset / Trial / NCT06464991

A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)

NCT06464991

Phase 3 Recruiting 240 enrolled Nanjing IASO Biotechnology Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, randomized, controlled, open-label, phase III clinical study to evaluate the efficacy of Equecabtagene Autoleucel Injection versus standard therapy in subjects with lenalidomid-refractory RRMM who have received 1-2 lines of prior therapy.

Timeline

Start
2024-03-27
Primary completion
2027-08
Completion
2030-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bortezomib Small molecule 1.3 mg/m2 Subcutaneous
Comparator Daratumumab Monoclonal antibody 16 mg/kg
Comparator Dexamethasone Small molecule 20 mg Oral
Subject Equecabtagene Autoleucel Cell therapy 1e+06 cells/kg
Comparator Pomalidomide Other / unclassified 4 mg

Indications