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

NCT06464991 | Recruiting Phase 3 DMC

• 1 other identifier: CT103AC004
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 28

Brief 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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Eque-cel

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) as assessed by Independent Review Committee (IRC)

  The time from randomization to the first documented disease progression as determined by IRC or death due to any cause

  up to 5 years from randomization

Secondary Outcomes (16)

• Minimal Residual Disease (MRD) negativity rate at 12 months

  up to 5 years from randomization

• Overall MRD negativity rate

  up to 5 years from randomization

• Duration of MRD negativity

  up to 5 years from randomization

• Complete Response Rate（CRR）

  up to 5 years from randomization

• Very good partial response or better response (≥VGPR) rate

  up to 5 years from randomization

Study Arms (2)

Experimental group

EXPERIMENTAL

Drug:Equecabtagene Autoleucel Injection

Drug: Equecabtagene Autoleucel Injection

Control group

ACTIVE COMPARATOR

Drug: Daratumumab, Bortezomib, Dexamethasone, Pomalidomide, DPd group: Daratumumab, Pomalidomide, Dexamethasone PVd group: Bortezomib, Dexamethasone, Pomalidomide

Drug: Daratumumab; Drug: Pomalidomide; Drug: Bortezomib; Drug: Dexamethasone

Interventions

Equecabtagene Autoleucel Injection DRUG

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

Also known as: FUCASO

Experimental group

Daratumumab DRUG

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

Control group

Pomalidomide DRUG

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

Control group

Bortezomib DRUG

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.

Control group

Dexamethasone DRUG

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.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%;
• \. Subjects agree to use effective tools or drug contraception (excluding safe period contraception) after signing the informed consent form.
• \. Subjects must agree to sign or personally sign an ethics committee-approved informed consent form before starting any screening procedures.

You may not qualify if:

• Subjects who have used or required long-term immune-suppressive agents (e.g., cyclosporine or systemic steroids) within 14 days prior to enrollment, but the use of physiological substitutes, intermittent, topical, and inhaled steroids is allowed.
• Subjects who have undergone autologous haematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks prior to randomization, or who have previously undergone allogeneic haematopoietic stem cell transplantation (Allo-HSCT).
• Subjects received the following anti-tumor treatments before enrollment: (1)Treated with an immunomodulator within 7 days, or; (2)Received plasma exchange, radiotherapy (except local radiotherapy for myeloma-related bone lesions), cytotoxic chemotherapy, treatment with proteasome inhibitors or other investigational drug within 14 days, or; (3) Treatment with monoclonal antibody for multiple myeloma within 21 days, or; (4) Received other anti-cancer therapy within 14 days or at least 5 half-lives (whichever is shorter) prior to enrollment.
• Significant cardiac disorder.
• Unstable systemic disease as judged by the investigator: including but not limited to severe liver, renal, or metabolic disease requiring medication.
• The subject will not be able to participate in this study if the investigator determines that the subject meets any of the following conditions: (1) Subjects with a history of allergic reaction to the excipient components (DMSO and albumin) of Eque-cel, fludarabine, cyclophosphamide, tocilizumab, or; (2) Subjects who are intolerant to dexamethasone, or; (3) Subjects who have a Life-threatening allergy, hypersensitivity reaction, or intolerance to pomalidomide and/or its excipients (intolerance is defined as discontinuation of prior treatment due to any AE related to pomalidomide) or;
• Have malignancies other than multiple myeloma within 5 years before screening, excluding cervical carcinoma in situ after radical surgery, basal cell or squamous cell skin cancer, localized cancer of prostate after radical prostatectomy, breast ductal carcinoma in situ after radical mastectomy or carcinoma papillary thyroid after radical thyroidectomy.
• Subjects suspected or confirmed to have central nervous system involvement of MM during the screening period.
• Subjects with concurrent plasma cell leukemia(defined as plasma cell proportion in peripheral blood \> 5%), Waldenström macroglobulinaemia, POEMS syndrome (polyneuropathy, organ hypertrophy, endocrinopathy, monoclonal protein and skin changes) or primary amyloidosis during screening period.
• Have extramedullary multiple myeloma-extraosseous (EM-E); have multiple extramedullary multiple myeloma-bone related (EM-B) and the maximum transverse diameter of any lesion is \>3cm; have a single EM-B and the maximum transverse diameter of the lesion is \>3cm.
• Had major surgery within 2 weeks prior to randomization or planned to have surgery within 2 weeks after study treatment (except for subjects who were scheduled to have surgery under local anesthesia).
• Subject with uncontrollable infection.
• Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and hepatitis B virus (HBV) DNA quantification in peripheral blood was higher than the lower limit of detection; hepatitis C virus (HCV) antibody positive and hepatitis C virus (HCV) RNA positive in peripheral blood; Human immunodeficiency virus (HIV) antibody positive; Syphilis test positive; positive cytomegalovirus (CMV) DNA.
• Pregnant or breastfeeding women.
• The subject has a history of central nervous system disorder within 6 months prior to signing the informed consent form.

Sponsors & Collaborators

• Nanjing IASO Biotechnology Co., Ltd.: lead

Study Sites (28)

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, China

RECRUITING

Beijing GoBoard Boren Hospital

Beijing, China

RECRUITING

Fu Xing Hospital, Capital Medical University

Beijing, China

RECRUITING

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Peking University First Hospital

Beijing, China

RECRUITING

Peking University Third Hospital

Beijing, China

RECRUITING

People's Hospital of Peking University

Beijing, China

RECRUITING

The first hospital of Jilin University

Changchun, China

RECRUITING

West China School of Medicine, West China Hospital of Sichuan University

Chengdu, China

RECRUITING

Xinqiao Hospital of AMU

Chongqing, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, China

RECRUITING

Sun Yat-sen University Cancer Centre

Guangzhou, China

RECRUITING

Zhujiang Hospital of Southern Medical University Guangdong

Guangzhou, China

RECRUITING

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, China

RECRUITING

The Second Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

Qilu Hospital of Shangdong University

Jinan, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, China

RECRUITING

Affiliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, China

RECRUITING

Jiangsu Province Hospital

Nanjing, China

RECRUITING

The Affiliated People's Hospital of Ningbo University

Ningbo, China

RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, China

RECRUITING

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjing, China

RECRUITING

Tianjin Medical University General Hospital

Tianjing, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

RECRUITING

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

RECRUITING

Henan Cancer Hospital Affilated Cancer Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab; pomalidomide; Bortezomib; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Gui Lu Qiu, PhD

  Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Zhen Cai, PhD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Wan

CONTACT

+86 025-58287610; yue.wan@iasobio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 18, 2024
• Study Start: March 27, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (28)