Trial Title:
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
NCT ID:
NCT06464991
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Bortezomib
Daratumumab
Pomalidomide
Conditions: Keywords:
Multiple Myeloma
Eque-cel
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Equecabtagene Autoleucel Injection
Description:
dosage form: injection, dosage: 1.0×10^6 CAR-T/kg, frequency: single dose.
Arm group label:
Experimental group
Other name:
FUCASO
Intervention type:
Drug
Intervention name:
Daratumumab
Description:
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
Arm group label:
Control group
Intervention type:
Drug
Intervention name:
Pomalidomide
Description:
dosage form:capsule. doseage form: capsule. dose level: 4mg/d. frequency: every cycle:
D1-D21 for DPd regimen, D1-D14 for PVd regimen.
Arm group label:
Control group
Intervention type:
Drug
Intervention name:
Bortezomib
Description:
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.
Arm group label:
Control group
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
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.
Arm group label:
Control group
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.
Detailed description:
Multiple myeloma (MM) is a malignant neoplasm of plasma cells that accounts for more than
10%-20% of hematologic malignancies worldwide, leading to marrow failure and bone
destruction. Equecabtagene Autoleucel (eque-cel) is an autologous chimeric antigen
receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), which
expressed on both mature B lymphocytes and malignant plasma cells. The primary objective
for this study is to compare the efficacy of eque-cel versus standard therapy in
lenalidomid-refractory RRMM. Subjects will undergo screening with informed consent. After
enrollment, randomization will be conducted followed by study treatment in experimental
or control group. A follow-up phase will include assessments for safety, efficacy
evaluation and pharmacokinetics monitoring (experimental arm) . The duration of this
trial is about 6 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1.18 to 70 years of age (inclusive of cutoff), regardless of gender. 2. Subjects were
previously diagnosed with multiple myeloma and received 1-2 lines of proteasome inhibitor
and immunomodulatory-based chemotherapy, with at least one complete cycle of each line of
treatment; Documented disease progression during or within 12 months after the most
recent anti-myeloma therapy.
3. Subjects were previously refractory to lenalidomide treatment. 4.ECOG score of 0 or
1. 5. Subjects must have adequate organ function and meet all the following
laboratory test results before enrollment: ① Blood routine: absolute neutrophil
count (ANC) ≥1×10^9/L (growth factor support allowed, but no supportive treatment
within 7 days before laboratory test); Absolute lymphocyte count (ALC) ≥0.3×10^9/L;
Platelet count ≥50×10^9 / L (no supportive platelets infusion allowed within 7 days
before lab test ); Hemoglobin ≥60g/L (no transfusion of red blood cells [RBC] within
7 days before the laboratory test; the use of recombinant human erythropoietin was
allowed); (2) liver 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 according to Cockcroft - Gault
formula of creatinine clearance (CrCl) should be ≥40 ml/min; ④ Coagulation function:
fibrinogen ≥1.0g/L; aPTT≤1.5 x ULN, prothrombin time (PT)≤1.5 x ULN; ⑤ 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. Before starting any screening program, subjects must have to agreed to sign or sign
the informed consent in person which have been approved by the ethics committee.
Exclusion Criteria:
1. Subjects who have used or need long-term use of immunosuppressive agents, such as
cyclosporine or systemic steroid) 14days before enrollment; but the use of
physiological substitute, intermittent, local and inhaled steroids is allowed.
2. Patients who had undergone autologous hematopoietic stem-cell transplantation
(Auto-HSCT) within 12 weeks before randomization or prior allogeneic hematopoietic
stem-cell transplantation (Allo-HSCT);
3. The subject received the following anti-tumor therapy before enrollment: ①
immunomodulatory therapy within 7 days, or; ② Plasma exchange, radiotherapy (except
for local radiotherapy for myeloma-associated bone lesions), cytotoxic chemotherapy,
proteasome inhibitor, or other investigation drug in clinical trial within 14 days;
or (3) monoclonal antibody treatment for multiple myeloma within 21 days, or; (4)
within 14 days or at least five half-life (will be subject to a shorter time) of
other anti-tumor treatment except for the above-mentioned ones;
4. Severe heart disease;
5. Unstable Systemic diseases per investigator's evaluation: including, but not limited
to, severe hepatic, renal, or metabolic diseases requiring medical treatment;
6. subjects with the following conditions per investigator's evaluation will not be
able to participate in the study: (1) allergic to excipients of Equecabtagene
Autoleucel Injection (DMSO and albumin), fludarabine, cyclophosphamide, tocilizumab,
or; ② subjects intolerant to dexamethasone, or; (3) subjects who have
life-threatening allergy, allergic reactions, or intolerance (intolerance is defined
as end of treatment for any pomalidomide related AE) with pomalidomide, or; ④
subjects who met the NCI-CTCAE v5.0 definition of grade 2 peripheral neuropathy with
pain or ≥ grade 3 peripheral neuropathy;
7. Diagnosed with another malignancy within 5 years before screening except for
multiple myeloma, excluding radical cervical carcinoma in situ, basal cell or
squamous epithelial cell skin cancer, radical localized prostate cancer, radical
ductal carcinoma in situ of the breast, or papillary thyroid cancer;
8. Patients with suspected or existed central nervous system involvement of plasma cell
neoplasms during screening;
9. subjects with plasma cell leukemia (defined as > 5% peripheral plasma cells),
Waldenstrom macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein, and cutaneous changes), or primary amyloidosis
previously or during screening period;
10. Multiple myeloma patients with extramedullary lesions (except for a single parosteal
extramedullary lesion ≤3cm in maximum transverse diameter)
11. Subject who underwent major surgery within 2 weeks before randomization or have
surgery plan within 2 weeks after study treatment (except for those scheduled
surgery under local anesthesia);
12. Subject with uncontrollable infection;
13. The hepatitis b surface antigen (HBsAg) or hepatitis b core antibody (HBcAb)
positive with hepatitis b virus (HBV) DNA quantification higher than the detection
limit; Hepatitis C virus (HCV) antibody positive with HCV RNA positive in peripheral
blood; human immunodeficiency virus (HIV) antibody positive; Syphilis testing
positive;
14. Women who are pregnant or lactating;
15. The subject has a existed central nervous system disease or with medical history of
CNS disease;
16. Non-hematologic toxicity due to prior therapy havn't been resolved to baseline or ≤
grade 1 (NCI-CTCAE version 5.0, excluding alopecia and grade 2 peripheral
neuropathy)
17. The subject had other conditions unsuitable for enrollment per investigator's
evaluation.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital, College of Medicine, Zhejiang University
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhen Cai
Facility:
Name:
Beijing Chao-Yang Hospital, Capital Medical University
Address:
City:
Beijing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
WenMing Chen
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jian Li
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
YuJun Dong
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
HongMei Jing
Facility:
Name:
People's Hospital of Peking University
Address:
City:
Beijing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jin Lu
Facility:
Name:
The first hospital of Jilin University
Address:
City:
Chang chun
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
FengYan Jin
Facility:
Name:
West China School of Medicine, West China Hospital of Sichuan University
Address:
City:
Chengdu
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
WenJiao Tang
Facility:
Name:
Xinqiao Hospital of AMU
Address:
City:
Chongqing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
YunJing Zeng
Facility:
Name:
Nanfang Hospital, Southern Medical University
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
XiaoLei Wei
Facility:
Name:
Sun Yat-sen University Cancer Centre
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
ZhongJun Xia
Facility:
Name:
Zhujiang Hospital of Southern Medical University Guangdong
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
YanJie He
Facility:
Name:
The Second Affiliated Hospital,Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
WenBin Qian
Facility:
Name:
Qilu Hospital of Shangdong University
Address:
City:
Jinan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
LuQun Wang
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Fei Li
Facility:
Name:
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Address:
City:
Nanjing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Bin Chen
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
LiJuan Chen
Facility:
Name:
The Affiliated People's Hospital of Ningbo University
Address:
City:
Ningbo
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ying Lu
Facility:
Name:
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
JianQing Mi
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
ChengCheng Fu
Facility:
Name:
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Address:
City:
Tianjing
Country:
China
Status:
Recruiting
Contact:
Last name:
LuGui Qiu, PhD
Facility:
Name:
Tianjin Medical University General Hospital
Address:
City:
Tianjing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Rong Fu
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Songfu Jiang
Facility:
Name:
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
ChunRui Li
Facility:
Name:
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Heng
Facility:
Name:
Henan Cancer Hospital Affilated Cancer Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
BaiJun Fang
Start date:
March 27, 2024
Completion date:
December 2030
Lead sponsor:
Agency:
Nanjing IASO Biotechnology Co., Ltd.
Agency class:
Industry
Source:
Nanjing IASO Biotechnology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06464991
