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

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 18 to 75 years of age (inclusive of critical values), either gender.

• The subject was previously diagnosed with multiple myeloma and had received 1-2 lines of therapy (including chemotherapy regimens based on proteasome inhibitors and immunomodulatory agents, with each line of therapy receiving at least 1 full cycle ; Documented disease progression during or within 12 months after the most recent anti-myeloma therapy.

• Subjects was lenalidomide-refractory during prior therapy.

• ECOG score of 0 or 1.

• Subjects must have appropriate organ function and meet all of the following laboratory test results before enrollment:

⁃ (1) Haematology: absolute neutrophil count (ANC) ≥1×10\^9/L (support with growth factor is allowed, but must not have received supportive treatment within 7 days before the laboratory test); Absolute lymphocyte count (ALC) ≥0.3×10\^9/L; Platelets ≥50×10\^9 / L (must not have received platelet transfusion within 7 days prior to laboratory test); Hemoglobin ≥60g/L (must not have received red blood cells transfusion within 7 days prior to laboratory test); (2) Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times of upper limit of normal (ULN); Serum total bilirubin ≤1.5 times of ULN; (3) Renal function: creatinine clearance (CrCl) calculated by Cockcroft-Gault formula ≥ 40 ml/min; (4) Coagulation: fibrinogen≥1.0 g/L; activated partial thromboplastin time (APTT) ≤ 1.5×ULN, pro-thrombin time (PT) ≤ 1.5 × ULN; (5) Pulse oxygen saturation \> 91%; (6) Left ventricular ejection fraction (LVEF)≥50%;

⁃ 6\. Subjects agree to use effective tools or drug contraception (excluding safe period contraception) after signing the informed consent form.

⁃ 7\. Subjects must agree to sign or personally sign an ethics committee-approved informed consent form before starting any screening procedures.

Locations
Other Locations
China
Beijing Chao-Yang Hospital, Capital Medical University
RECRUITING
Beijing
Beijing GoBoard Boren Hospital
RECRUITING
Beijing
Fu Xing Hospital, Capital Medical University
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
People's Hospital of Peking University
RECRUITING
Beijing
The first hospital of Jilin University
RECRUITING
Changchun
West China School of Medicine, West China Hospital of Sichuan University
RECRUITING
Chengdu
Xinqiao Hospital of AMU
RECRUITING
Chongqing
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Centre
RECRUITING
Guangzhou
Zhujiang Hospital of Southern Medical University Guangdong
RECRUITING
Guangzhou
The First Affiliated Hospital, College of Medicine, Zhejiang University
RECRUITING
Hangzhou
The Second Affiliated Hospital,Zhejiang University School of Medicine
RECRUITING
Hangzhou
Qilu Hospital of Shangdong University
RECRUITING
Jinan
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Affiliated Drum Tower Hospital, Medical School of Nanjing University
RECRUITING
Nanjing
Jiangsu Province Hospital
RECRUITING
Nanjing
The Affiliated People's Hospital of Ningbo University
RECRUITING
Ningbo
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
RECRUITING
Tianjing
Tianjin Medical University General Hospital
RECRUITING
Tianjing
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Henan Cancer Hospital Affilated Cancer Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Yue Wan
yue.wan@iasobio.com
+86 025-58287610
Time Frame
Start Date: 2024-03-27
Estimated Completion Date: 2030-12
Participants
Target number of participants: 240
Treatments
Experimental: Experimental group
Drug:Equecabtagene Autoleucel Injection
Active_comparator: Control group
Drug:~Daratumumab, Bortezomib, Dexamethasone, Pomalidomide, DPd group: Daratumumab, Pomalidomide, Dexamethasone PVd group: Bortezomib, Dexamethasone, Pomalidomide
Related Therapeutic Areas
Sponsors
Leads: Nanjing IASO Biotechnology Co., Ltd.

This content was sourced from clinicaltrials.gov