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RECRUITING
NCT06464991
PHASE3

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

Sponsor: Nanjing IASO Biotechnology Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase III Randomized, Controlled Study of Equecabtagene Autoleucel Injection in Subjects With Lenalidomide-Refractory R/R Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2024-03-27

Completion Date

2030-12

Last Updated

2025-07-20

Healthy Volunteers

No

Interventions

DRUG

Equecabtagene Autoleucel Injection

dosage form: injection, dosage: 1.0×10\^6 CAR-T/kg, frequency: single dose.

DRUG

Daratumumab

dosage form: Injection dose level:16mg/kg frequency: 28days/cycle for DPd regimen * Cycle1-2:D1, D8, D15, D22; * Cycle3-6:D1, D15; * above Cycle7:D1

DRUG

Pomalidomide

dosage form:capsule. doseage form: capsule. dose level: 4mg/d. frequency: every cycle: D1-D21 for DPd regimen, D1-D14 for PVd regimen.

DRUG

Bortezomib

dosage form: subcutaneous injection. dose level: 1.3mg/m2. frequency: 21days/cycle for PVd regimen cycle 1-8: D1,D4, D8, D11; above cycle 9: D1, D8.

DRUG

Dexamethasone

dosage form: oral or intravenus injection. dose level:20mg/d. frequency: for DPd: every cycle, D1, D2, D8, D9, D15, D16, D22, D23; for PVd: Cycle1-8:D1, D2, D4, D5, D8, D9, D11, D12; above Cycle 9: D1, D2, D8, D9.

Locations (28)

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, China

Beijing GoBoard Boren Hospital

Beijing, China

Fu Xing 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

Changchun, 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 First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, 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