New drug shows promise in multiple myeloma battle

NCT ID NCT07477587

Disease control Sponsor: Shanghai Henlius Biotech Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if a new drug, HLX15-SC, works as well as the approved drug DARZALEX FASPRO® for people with newly diagnosed multiple myeloma who cannot have a stem cell transplant. About 258 adults will receive either the new drug or the approved one, along with standard medications, for up to 32 weeks. The goal is to compare how the drugs move through the body, their safety, and their effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 258 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years at the time of signing the informed consent form (ICF). 2. Body mass index (BMI): 18.5 kg/m2 ≤ BMI \< 28 kg/m2. 3. Subjects must participate voluntarily, understand the study, and sign the ICF. 4. Patients must have a documented diagnosis of multiple myeloma (MM) according to the International Myeloma Working Group (IMWG) criteria, with measurable lesion . 5. Serum albumin ≥ 35 g/L. 6. Newly diagnosed, untreated, and considered ineligible for high-dose chemotherapy with autologous stem cell transplantation (ASCT) by the investigator. 7. The patient's ECOG performance status must be 0 or 1 . 8. Patient must have clinical laboratory values meeting the following criteria during the screening period: 1. Hemoglobin ≥ 7.5 g/dL (≥ 5 mmol/L; red blood cell \[RBC\] transfusion or use of recombinant human erythropoietin at least 1 week prior to randomization is allowed). 2. Absolute neutrophil count (ANC) ≥ 1.0 × 109/L (use of granulocyte-colony stimulating factor \[G-CSF\] is allowed). 3. Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN). 4. Without the following evidence of impaired liver function, including mild impairment (total bilirubin ≤ ULN and AST \> ULN or ULN \< total bilirubin ≤ 1.5 x ULN), moderate impairment (1.5 x ULN \< total bilirubin ≤ 3 x ULN), and severe impairment (total bilirubin \> 3 x ULN). 5. Measured creatinine clearance ≥ 40 mL/min . 6. Corrected serum calcium \< 14 mg/dL (\< 3.5 mmol/L); or free ionized calcium \< 6.5 mg/dL (\< 1.6 mmol/L) . 7. Platelet count ≥ 70 × 109/L for patients with plasma cells \< 50% of bone marrow nucleated cells; platelet count \> 50 × 109/L for all other patients (transfusion within 3 days prior to randomization to achieve the minimum platelet count is not permitted). 9. Contraceptive criteria: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 1. Female patients: a female patient is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP: must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously from signed ICF to at least 140 days following the last dose of study products. This includes one highly effective contraceptive method with a failure rate of \< 1% per year (tubal ligation, intrauterine device, hormonal \[birth control pills, injections, hormonal patches, vaginal rings or implants\] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy. The subjects also need to agree not to donate or cryopreservation eggs (ova, oocytes) from signed ICF to at least 140 days following the last dose of study products. 2. Male patients: male patients are eligible to participate if they agree to the following during the intervention period and for at least 140 days following the last dose of study products: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent. or Agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year as when having sexual intercourse with a woman of childbearing potential who is not currently pregnant. Agree not to donate or cryopreservation sperm. 10. A WOCBP must have a negative serum pregnancy test at screening within 72 h prior to randomization. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy Exclusion Criteria: 1. Patient has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions. 2. Patient has plasma cell leukemia (according to IMWG criterion: ≥ 5% of plasma cells in the peripheral blood and/or an absolute plasma cell count of ≥ 2 x 109/L) or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes). 3. Patient has prior or current systemic therapy or ASCT for MM, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before randomization. 4. Patient has peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6. 5. Patient has a history of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence within 3 years). 6. Patient has clinical signs of meningeal involvement of MM. 7. Patient has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second \[FEV1\] \< 50% of predicted normal), persistent asthma, or a history of asthma within the last 2 years. Patient with known or suspected COPD or asthma must have a FEV1 test during screening. 8. Patient is known to be seropositive for history of human immunodeficiency virus (HIV) or known to have treponema pallidum antibodies (Anti-TP). 9. Patient is known to have active hepatitis B or C. 1. Patient is seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Patients with resolved infection (that is, patients who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[Anti-HBc\] and/or antibodies to hepatitis B surface antigen \[Anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. EXCEPTION: Patients with serologic findings suggestive of HBV vaccination (Anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR. 2. Patient is seropositive for hepatitis C must be screened using PCR measurement of hepatitis C virus (HCV) ribonucleic acid (RNA) levels. Those who are PCR positive will be excluded. 10. Patient has any concurrent medical or psychiatric condition or disease (e.g., active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study. 11. Patient has clinically significant cardiac disease, including: 1. Myocardial infarction within 1 year before randomization, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association \[NYHA\] Class III-IV ). 2. Cardiac arrhythmia (NCI-CTCAE Version 6 Grade ≥ 2) or clinically significant ECG abnormalities. 3. Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) (See Appendix 6) \> 470 ms. 12. Patient has known allergies, hypersensitivity, or intolerance to lenalidomide, corticosteroids, monoclonal antibodies or human proteins, or their excipients or known sensitivity to mammalian-derived products. 13. Patient has history of drug abuse or substance abuse one year prior to randomization. Patient is known or suspected of not being able to comply with the study protocol (e.g., because of alcoholism, drug dependency, or psychological disorder). 14. Patient is a woman who is pregnant, or breast-feeding, or planning to become pregnant or donate eggs (ova, oocytes) while enrolled in this study or within 140 days after the last dose of study products. Or patient is a man who plans to father a child and/or donate sperm while enrolled in this study or within 140 days after the last dose of study products. Patient does not agree to abstain completely from sexual intercourse, or plan to use a contraceptive method that is not acceptable to the investigator (unacceptable methods of contraception include: i. periodic abstinence \[such as calendar method, ovulation method, basal body temperature method, post-ovulation safety period method, etc.\], withdrawal, etc.; ii. medical contraceptive measures such as oral contraceptives, contraceptive injections, contraceptive patches, subcutaneous implantation, intrauterine hormone contraceptive devices, local contraceptives such as spermicides, etc.). 15. Patient had radiation therapy within 14 days of randomization. 16. Patient had plasmapheresis within 28 days of randomization. 17. Patient had a history of blood donation or total blood loss of 200 mL or more within 3 months before randomization. 18. Patient had major surgery within 28 days before randomization or has not fully recovered from surgery, or has surgery planned during the time the patient is expected to participate in the study or within 28 days after the last dose of study treatment. Kyphoplasty is not considered major surgery. 19. Patient in clinical trials of any other drug or device within 3 months (or 5 half-lives of the corresponding investigational product if the half-life of the drug is long \[5 half-lives \> 3 months\]) before randomization. 20. Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma (MM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

81 sites in 5 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Affiliated Hospital of Hebei University
RECRUITING

Baoding, Hebei, 071030, China
Affiliated Hospital of Jiangnan University
RECRUITING

Wuxi, Jiangsu, 214000, China
Affiliated Zhongshan Hospital of Dalian University
RECRUITING

Dalian, Liaoning, 116001, China
American Oncology Network Vista Oncology Division / Physician partner associate
RECRUITING

Olympia, Washington, 98506, United States
Anhui Provincial Cancer Hospital
RECRUITING

Hefei, Anhui, 230031, China
Beijing Chao-Yang Hospital Capital Medical University
RECRUITING

Beijing, Beijing Municipality, 100027, China
Cancer Specialists of North Florida
RECRUITING

Jacksonville, Florida, 32256, United States
Cangzhou People's Hospital
RECRUITING

Cangzhou, Hebei, 061000, China
Clinical Hospital Centre Zemun
NOT_YET_RECRUITING

Belgrade, 11080, Serbia
D&H National Research Center
RECRUITING

Margate, Florida, 33063, United States
First Affiliated Hospital of Gannan Medical University
RECRUITING

Ganzhou, Jiangxi, 341000, China
Florida Clinical Trials Group
RECRUITING

Plantation, Florida, 33322, United States
Florida Clinical Trials Group
RECRUITING

Tamarac, Florida, 33321, United States
Guangdong General Hospital
RECRUITING

Guangzhou, Guangdong, 510080, China
Guangxi Medical University Cancer Hospital
RECRUITING

Nanning, Guangxi, 530213, China
Guangzhou First People's Hospital
RECRUITING

Guangzhou, Guangdong, 510013, China
Hangzhou First People's Hospital
RECRUITING

Hangzhou, Zhejiang, 310006, China
Harbin Medical University Cancer Hospital
RECRUITING

Harbin, Heilongjiang, 150069, China
Hebei medical university third hospital
RECRUITING

Shijiazhuang, Hebei, 050052, China
Henan Cancer Hospital
RECRUITING

Zhengzhou, Henan, 450003, China
Henan Provincial People's Hospital
RECRUITING

Zhengzhou, Henan, 450003, China
Highlands Oncology Group, PA
RECRUITING

Springdale, Arkansas, 72762, United States
JSC K. Eristavi National Center of Experimental and Clinical Surgery
NOT_YET_RECRUITING

Tbilisi, 0159, Georgia
Jiangxi Cancer Hospital
RECRUITING

Nanchang, Jiangxi, 330029, China
Jining No.1 People's Hospital
RECRUITING

Jining, Shandong, 272000, China
LLC Caucasus Medical Centre
NOT_YET_RECRUITING

Tbilisi, 0160, Georgia
Liaoning Cancer Hospital & Institute
RECRUITING

Shenyang, Liaoning, 110041, China
Liuzhou Worker's Hospital
RECRUITING

Liuzhou, Guangxi, 545007, China
Meizhou People's Hospital
RECRUITING

Meizhou, Guangdong, 514031, China
Nuclear Industry General Hospital (The Second Affiliated Hospital of Soochow University)
RECRUITING

Suzhou, Jiangsu, 215004, China
Ocala Oncology Center
RECRUITING

Ocala, Florida, 34474, United States
Oncology Consultants (P1 Trials -Exigent Network)
RECRUITING

Houston, Texas, 77030, United States
Peking University First Hospital
RECRUITING

Beijing, Beijing Municipality, 100035, China
Peking University Shenzhen Hospital
RECRUITING

Shenzhen, Guangdong, 518036, China
Peking University Third Hospital
RECRUITING

Beijing, Beijing Municipality, 100191, China
Perth Blood Institute
RECRUITING

Perth, 6005, Australia
Pontchartrain Cancer Center
RECRUITING

Covington, Louisiana, 70433, United States
Renmin Hospital of Wuhan University
RECRUITING

Wuhan, Hubei, 430061, China
Shandong Provincial Hospital
RECRUITING

Jinan, Shandong, 250022, China
Shanxi Cancer Hospital
RECRUITING

Taiyuan, Shanxi, 030013, China
Shengjing Hospital of China Medical University
RECRUITING

Shenyang, Liaoning, 110004, China
Shenzhen People's Hospital
RECRUITING

Shenzhen, Guangdong, 518020, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
RECRUITING

Chengdu, Sichuan, 610073, China
Sichuan Cancer Hospital
RECRUITING

Chengdu, Sichuan, 610041, China
Sir Run Run Hospital of Nanjing Medical University
RECRUITING

Nanjing, Jiangsu, 211166, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine（The Grand Canal Campus）
RECRUITING

Hangzhou, Zhejiang, 310016, China
The Affiliated Hospital of Guizhou Medical University
RECRUITING

Guiyang, Guizhou, 550004, China
The Affiliated Hospital of Inner Mongolia Medical University
RECRUITING

Hohhot, Inner Mongolia, 010030, China
The Affiliated Hospital of Qingdao University
RECRUITING

Qingdao, Shandong, 266001, China
The Affiliated Hospital of Xuzhou Medical University
RECRUITING

Xuzhou, Jiangsu, 221006, China
The First Affiliated Hospital Of University South China
RECRUITING

Hengyang, Hunan, 421001, China
The First Affiliated Hospital of Bengbu Medical University
RECRUITING

Bengbu, Anhui, 233000, China
The First Affiliated Hospital of Chongqing Medical University
RECRUITING

Chongqing, Chongqing Municipality, 400016, China
The First Affiliated Hospital of Fujian Medical University
RECRUITING

Fuzhou, Fujian, 350004, China
The First Affiliated Hospital of Henan University of Science & Techinology
RECRUITING

Luoyang, Henan, 471003, China
The First Affiliated Hospital of Nanchang University
RECRUITING

Nanchang, Jangxi, 330008, China
The First Affiliated Hospital of Ningbo University
RECRUITING

Ningbo, Zhejiang, 315010, China
The First Affiliated Hospital of Xiamen University
RECRUITING

Xiamen, Fujian, 361001, China
The First Affiliated Hospital of Zhengzhou University
RECRUITING

Zhengzhou, Henan, 450052, China
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING

Hangzhou, Zhejiang, 310020, China
The First Hospital of China Medical University
RECRUITING

Shenyang, Liaoning, 110001, China
The Second Affiliated Hospital of Anhui Medical University
RECRUITING

Hefei, Anhui, 230601, China
The Second Affiliated Hospital of Wenzhou Medical University
RECRUITING

Wenzhou, Zhejiang, 325000, China
The Second Hospital of Hebei Medical Universit
RECRUITING

Shijiazhuang, Hebei, 050071, China
The Second Hospital of Shanxi Medical University
RECRUITING

Taiyuan, Shanxi, 030001, China
The Second Xiangya Hospital of Central South University
RECRUITING

Changsha, Hunan, 410011, China
The second affiliated hospital of Nanchang University
RECRUITING

Nanchang, Jangxi, 330008, China
Tianjin Cancer Hospital Airport Hospital
RECRUITING

Tianjin, Tianjin Municipality, 300308, China
Tianjin Medical University Cancer Institute & Hospital
RECRUITING

Tianjin, Tianjin Municipality, 300060, China
Tianjin People's Hospital
RECRUITING

Tianjin, Tianjin Municipality, 300131, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology
RECRUITING

Wuhan, Hubei, 430030, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING

Wuhan, Hubei, 430014, China
University Clinical Center Kragujevac
NOT_YET_RECRUITING

Kragujevac, 34000, Serbia
University Clinical Center Nis
NOT_YET_RECRUITING

Niš, 8000, Serbia
Weifang People's Hospital
RECRUITING

Weifang, Shandong, 261041, China
Xinxiang Central Hospital
RECRUITING

Xinxiang, Henan, 453000, China
Zhejiang Provincial People's Hospital
RECRUITING

Hangzhou, Zhejiang, 310015, China
Zhongda Hospital Southeast University
RECRUITING

Nanjing, Jiangsu, 210009, China
Zhongnan Hospital of Wuhan University
RECRUITING

Wuhan, Hubei, 430071, China
Zhongshan Hospital, Fudan University
RECRUITING

Shanghai, Shanghai Municipality, 200032, China
Zhujiang Hospital of Southern Medical University
RECRUITING

Guangzhou, Guangdong, 510220, China

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