A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
NCT Number: NCT06464991
Acronym: FUMANBA-03
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Multiple Myeloma
Interventions: DRUG: Equecabtagene Autoleucel Injection|DRUG: Daratumumab|DRUG: Pomalidomide|DRUG: Bortezomib|DRUG: Dexamethasone
Sponsor: Nanjing IASO Biotechnology Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-27
Completion Date: 2030-12
Locations: The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China|Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China|Peking Union Medical College Hospital, Beijing, China|Peking University First Hospital, Beijing, China|Peking University Third Hospital, Beijing, China|People's Hospital of Peking University, Beijing, China|The first hospital of Jilin University, Chang chun, China|West China School of Medicine, West China Hospital of Sichuan University, Chengdu, China|Xinqiao Hospital of AMU, Chongqing, China|Nanfang Hospital, Southern Medical University, Guangzhou, China|Sun Yat-sen University Cancer Centre, Guangzhou, China|Zhujiang Hospital of Southern Medical University Guangdong, Guangzhou, China|The Second Affiliated Hospital,Zhejiang University School of Medicine, Hangzhou, China|Qilu Hospital of Shangdong University, Jinan, China|The First Affiliated Hospital of Nanchang University, Nanchang, China|Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China|Jiangsu Province Hospital, Nanjing, China|The Affiliated People's Hospital of Ningbo University, Ningbo, China|Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China|The First Affiliated Hospital of Soochow University, Suzhou, China|Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjing, China|Tianjin Medical University General Hospital, Tianjing, China|The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China|Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China|Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China|Henan Cancer Hospital Affilated Cancer Hospital of Zhengzhou University, Zhengzhou, China

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.

Primary Outcome Measures: Progression Free Survival per independent review committee, PFS per IRC, The time from randomization to the first time of documented disease progression or death from any cause per IRC, up to 5 years from randomization
Secondary Outcome Measures: Minimal Residual Disease Negativity Rate, Proportion of subjects with MRD-negative bone marrow detection by next-generation flow cytometry following study therapy, up to 5 years from randomization|Duration of MRD negativity, The time from the first MRD negative to the first MRD negative positive transfer, up to 5 years from randomization|Complete Response rate, Proportion of subjects who achieved CR or better response after receiving study therapy, up to 5 years from randomization|Rate of very good partial response or better, Proportion of subjects who achieved strict complete response (sCR), CR, and VGPR after receiving study therapy, up to 5 years from randomization|Overall Response Rate, Proportion of subjects who achieved sCR, CR, VGPR, and PR after receiving study therapy, up to 5 years from randomization|Event Free Survival, The time from the start of randomization until the first occurrence of any of the following events, including death, disease progression, change of treatment, addition of another treatment, fatal or intolerable side effects, up to 5 years from randomization|Overall Survival, The time from randomization until death from any cause, up to 5 years from randomization|Time to Next Treatment, The time from receipt of the trial drug to initiation of the next line of treatment, up to 5 years from randomization|incidence of Adverse events, Safety Endpoint, up to 5 years from randomization|Pharmacokinetic Endpoint-Cmax, The maximum concentration (Cmax) of CAR VCN and BCMA CAR-T in peripheral blood after CAR-T infusion, up to 5 years from Eque-cel infusion|Pharmacokinetic Endpoint-Tmax, the time for CAR VCN and BCMA CAR-T to reach the maximum concentration (Tmax) after CAR-T infusion, up to 5 years from Eque-cel infusion|Pharmacokinetic Endpoint-AUC, Area under the curve of 29, 85, 169 days and the last time point of PK detection (AUC0-29d, AUC0-85d, AUC0-169d, AUC0-last) for CAR VCN; Area under the curve of 29 days (AUC0-29) for BCMA CAR-T., up to 5 years from Eque-cel infusion|Pharmacodynamic Endpoint, The concentration of soluble BCMA in peripheral blood of experimental group at each time point, up to 5 years from Eque-cel infusion|Health Related Quality of Life Endpoint, Symptoms, function, and overall HRQoL were collected using the validated Patient-Reported Outcomes (PRO) questionnaire, up to 5 years from randomization