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AzTrials

Multiple Myeloma (MM)Phase 1NCT07477587

A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma

A Phase 1 study testing HLX15-SC-Rd and US-DARZALEX FASPRO®-Rd in people with Multiple Myeloma (MM), run by Shanghai Henlius Biotech at 84 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to compare the pharmacokinetic (PK) similarity, safety, tolerability, immunogenicity, and efficacy of HLX15-SC versus US-DARZALEX FASPRO® following single and multiple subcutaneous (SC) injections in newly diagnosed MM patients ineligible for transplant. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma (MM)
What is being tested?
HLX15-SC-Rd and US-DARZALEX FASPRO®-Rd
Could I receive a placebo?
No, everyone receives an active treatment
How many people
258 participants
Where
84 sitesin 5 countries
Study dates
25 May 2026to 22 Feb 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years at the time of signing the informed consent form (ICF).
  • Body mass index (BMI): 18.5 kg/m2 ≤ BMI < 28 kg/m2.
  • Subjects must participate voluntarily, understand the study, and sign the ICF.
  • Patients must have a documented diagnosis of multiple myeloma (MM) according to the International Myeloma Working Group (IMWG) criteria, with measurable lesion .
  • Serum albumin ≥ 35 g/L.
  • Newly diagnosed, untreated, and considered ineligible for high-dose chemotherapy with autologous stem cell transplantation (ASCT) by the investigator.
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  • The patient's ECOG performance status must be 0 or 1 .
  • Patient must have clinical laboratory values meeting the following criteria during the screening period:
  • 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).
  • Absolute neutrophil count (ANC) ≥ 1.0 × 109/L (use of granulocyte-colony stimulating factor [G-CSF] is allowed).
  • Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN).
  • 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).
  • Measured creatinine clearance ≥ 40 mL/min .
  • Corrected serum calcium < 14 mg/dL (< 3.5 mmol/L); or free ionized calcium < 6.5 mg/dL (< 1.6 mmol/L) .
  • 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).
  • 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.
  • 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.
  • 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.
  • 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

Who cannot join

  • 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.
  • 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).
  • 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.
  • 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.
  • 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).
  • Patient has clinical signs of meningeal involvement of MM.
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  • 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.
  • Patient is known to be seropositive for history of human immunodeficiency virus (HIV) or known to have treponema pallidum antibodies (Anti-TP).
  • Patient is known to have active hepatitis B or C.
  • 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.
  • 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.
  • 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.
  • Patient has clinically significant cardiac disease, including:
  • 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 ).
  • Cardiac arrhythmia (NCI-CTCAE Version 6 Grade ≥ 2) or clinically significant ECG abnormalities.
  • Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) (See Appendix 6) > 470 ms.
  • 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.
  • 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).
  • 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.).
  • Patient had radiation therapy within 14 days of randomization.
  • Patient had plasmapheresis within 28 days of randomization.
  • Patient had a history of blood donation or total blood loss of 200 mL or more within 3 months before randomization.
  • 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.
  • 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.
  • 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

Trial locations and contacts

84 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Yinping Zhong contact

+86-13983654553

Yinping_Zhong@henlius.com

84 sites in 5 countries

China66 sites, 66 recruiting

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, 071030

    Recruiting

  • Beijing Chao-Yang Hospital Capital Medical University

    Beijing, Beijing Municipality, 100027

    Recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100035

    Recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Recruiting

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui, 233000

    Recruiting

  • Cangzhou People's Hospital

    Cangzhou, Hebei, 061000

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041

    Recruiting

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610073

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

    Recruiting

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning, 116001

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350004

    Recruiting

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, 341000

    Recruiting

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510013

    Recruiting

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

    Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510220

    Recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

    Recruiting

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 310006

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310015

    Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine（The Grand Canal Campus）

    Hangzhou, Zhejiang, 310016

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310020

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150069

    Recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230031

    Recruiting

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601

    Recruiting

  • The First Affiliated Hospital Of University South China

    Hengyang, Hunan, 421001

    Recruiting

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010030

    Recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong, 250022

    Recruiting

  • Jining No.1 People's Hospital

    Jining, Shandong, 272000

    Recruiting

  • Liuzhou Worker's Hospital

    Liuzhou, Guangxi, 545007

    Recruiting

  • The First Affiliated Hospital of Henan University of Science & Techinology

    Luoyang, Henan, 471003

    Recruiting

  • Meizhou People's Hospital

    Meizhou, Guangdong, 514031

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jangxi, 330008

    Recruiting

  • The second affiliated hospital of Nanchang University

    Nanchang, Jangxi, 330008

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029

    Recruiting

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

    Recruiting

  • Sir Run Run Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 211166

    Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530213

    Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266001

    Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

    Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110041

    Recruiting

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020

    Recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

    Recruiting

  • Hebei medical university third hospital

    Shijiazhuang, Hebei, 050052

    Recruiting

  • The Second Hospital of Hebei Medical Universit

    Shijiazhuang, Hebei, 050071

    Recruiting

  • Nuclear Industry General Hospital (The Second Affiliated Hospital of Soochow University)

    Suzhou, Jiangsu, 215004

    Recruiting

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030013

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

    Recruiting

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality, 300131

    Recruiting

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin, Tianjin Municipality, 300308

    Recruiting

  • Weifang People's Hospital

    Weifang, Shandong, 261041

    Recruiting

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Recruiting

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

    Wuhan, Hubei, 430014

    Recruiting

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei, 430030

    Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430061

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

    Recruiting

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu, 214000

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361001

    Recruiting

  • Xinxiang Central Hospital

    Xinxiang, Henan, 453000

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221006

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Recruiting

Other trials in China

United States12 sites, 12 recruiting

  • Pontchartrain Cancer Center

    Covington, Louisiana, 70433

    Recruiting

  • Genesis Medical Research

    Dyer, Indiana, 46311

    Recruiting

  • Optum Care Washington

    Everett, Washington, 98201

    Recruiting

  • Oncology Consultants (P1 Trials -Exigent Network)

    Houston, Texas, 77030

    Recruiting

  • Lumi Research

    Houston, Texas, 77090

    Recruiting

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

    Recruiting

  • D&H National Research Center

    Margate, Florida, 33063

    Recruiting

  • Ocala Oncology Center

    Ocala, Florida, 34474

    Recruiting

  • American Oncology Network Vista Oncology Division / Physician partner associate

    Olympia, Washington, 98506

    Recruiting

  • Florida Clinical Trials Group

    Plantation, Florida, 33322

    Recruiting

  • Highlands Oncology Group, PA

    Springdale, Arkansas, 72762

    Recruiting

  • Florida Clinical Trials Group

    Tamarac, Florida, 33321

    Recruiting

Other trials in United States

Serbia3 sites, 3 recruiting

  • Clinical Hospital Centre Zemun

    Belgrade, 11080

    Not yet recruiting

  • University Clinical Center Kragujevac

    Kragujevac, 34000

    Not yet recruiting

  • University Clinical Center Nis

    Niš, 8000

    Not yet recruiting

Other trials in Serbia

Georgia2 sites, 2 recruiting

  • JSC K. Eristavi National Center of Experimental and Clinical Surgery

    Tbilisi, 0159

    Not yet recruiting

  • LLC Caucasus Medical Centre

    Tbilisi, 0160

    Not yet recruiting

Other trials in Georgia

Australia1 site, 1 recruiting

  • Perth Blood Institute

    Perth, 6005

    Recruiting

Other trials in Australia

About this study

Official title: A Randomized, Double-blind, Parallel-controlled Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma

The purpose of this study is to compare the pharmacokinetic (PK) similarity, safety, tolerability, immunogenicity, and efficacy of HLX15-SC versus US-DARZALEX FASPRO® following single and multiple subcutaneous (SC) injections in newly diagnosed MM patients ineligible for transplant.

Participants who meet all inclusion criteria and none of the exclusion criteria will receive either the HLX15-SC-Rd regimen or the D-Rd regimen for 4 cycles (one cycle = 4 weeks). After 4 cycles of treatment, based on clinical benefit and participant preference, participants may continue to receive the locally marketed daratumumab subcutaneous formulation (Dara-SC) in combination with Rd according to clinical practice, up to 32 weeks or until loss of clinical benefit, death, unacceptable toxicity, withdrawal of informed consent, or any other protocol-specified reason, whichever occurs first. After 32 weeks of dosing, participants will continue to receive appropriate standard of care according to local guidelines (including marketed Dara-SC).

Being tested
HLX15-SC-Rd, US-DARZALEX FASPRO®-Rd
Keywords
Transplant ineligible Patients with Newly Diagnosed Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLX15-SC-RdDrug

    Subjects will receive 1800 mg HLX15-SC via SC administration for up to 16 weeks: weekly during Week 1-8 (Cycle 1-2; 1 cycle = 4 weeks) and every two weeks during Week 9-16 (Cycle 3-4).

  • US-DARZALEX FASPRO®-RdDrug

    Subjects will receive 1800 mg US-DARZALEX FASPRO® via SC administration for up to 16 weeks: weekly during Week 1-8 (Cycle 1-2; 1 cycle = 4 weeks) and every two weeks during Week 9-16 (Cycle 3-4).

Study groups in NCT07477587
Study groupRoleWhat they receive
HLX15-SC-RdExperimentalHLX15-SC-Rd
Receives: Drug: HLX15-SC-Rd
US-DARZALEX FASPRO®-RdActive comparatorUS-DARZALEX FASPRO®-Rd
Receives: Drug: US-DARZALEX FASPRO®-Rd

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pharmacokinetic (PK) similarity

    Area under the serum concentration-time curve from time 0 to day 7 (AUC0-7d) after the 1st dose.

    Measured: 7 days

  2. pharmacokinetic (PK) similarity

    The maximum (peak) serum drug concentration (Cmax) after the 1st dose.

    Measured: 7 days

  3. pharmacokinetic (PK) similarity

    Area under the serum concentration-time curve within a dosing interval at steady-state (AUCss) after the 12th dose

    Measured: 16 weeks

  4. pharmacokinetic (PK) similarity

    The maximum (peak) serum drug concentration at steady-state (Cmax,ss) after the 12th dose

    Measured: 16 weeks

Secondary outcomes (18)

  1. PK characteristics

    trough concentration (Ctrough)

    Measured: 16 weeks

  2. PK characteristics

    trough concentration at steady state (Ctrough,ss).

    Measured: 16 weeks

  3. Safety: Adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)

    Adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) terms and frequency of occurrence judged by investigators

    Measured: 16 weeks

  4. Safety: Vital Signs

    Vital Signs: including blood pressure (systolic and diastolic; mmHg) , pulse rate (beats/min) measured by hematomanometer

    Measured: 16 weeks

  5. Safety: Vital Signs

    including body temperature (°C) measured by clinical thermometer

    Measured: 16 weeks

  6. Safety: Physical examinations

    Physical examinations: includes general condition; head and neck; mucous membranes; chest; abdomen; spine; extremities; musculoskeletal system; neurological system; lymphatic system; and skin checked by investigators

    Measured: 16 weeks

  7. Safety: Laboratory tests

    Laboratory tests: include hematology, blood chemistry, and urinalysis measured by the department of medical laboratory in site

    Measured: 16 weeks

  8. Safety: Electrocardiography

    Electrocardiography: 12-lead ECG will be performed by qualified personnel using an ECG machine, includes heart rate（beats per minute ）

    Measured: 16 weeks

  9. Safety: Electrocardiography

    Electrocardiography: 12-lead ECG will be performed by qualified personnel using an ECG machine, includes PR interval（msec）.

    Measured: 16 weeks

  10. Safety: Electrocardiography

    Electrocardiography: 12-lead ECG will be performed by qualified personnel using an ECG machine, includes QRS duration (msec).

    Measured: 16 weeks

  11. Safety: Electrocardiography

    Electrocardiography: 12-lead ECG will be performed by qualified personnel using an ECG machine, includes QTc interval (msec).

    Measured: 16 weeks

  12. Immunogenicity:

    Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) against the study products (HLX15-SC and US-DARZALEX FASPRO®) and hyaluronidase.

    Measured: 16 weeks

  13. Efficacy:ORR

    Investigator-assessed overall response rate (ORR): is defined as the percentage of all patients achieving a PR or better after the randomization date.

    Measured: 16 weeks

  14. Efficacy: partial response (PR) rate

    Partial response (PR) rate is defined as the percentage of all patients achieving a PR at any time point after the randomization date

    Measured: 16 weeks

  15. Efficacy: very good partial response (VGPR) rate

    Very good partial response (VGPR) rate is defined as the percentage of all patients achieving a VGPR at any time point after the randomization date.

    Measured: 16 weeks

  16. Efficacy: complete response (CR) rate

    Complete response (CR) rate is defined as the percentage of all patients achieving a CR at any time point after the randomization date.

    Measured: 16 weeks

  17. Efficacy: stringent complete response (sCR) rate

    Stringent complete response (sCR) rate is defined as the percentage of all patients achieving an sCR at any time point after the randomization date.

    Measured: 16 weeks

  18. Efficacy: time to response

    Time to Response (TTR) is defined as the time from randomization to the first documented response of PR or better. TTR will be analyzed only for patients who achieve a response of PR or better.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2026
  2. Study start25 May 2026
  3. Primary completion25 May 2027 (estimated)
  4. Study completion22 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
258 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07477587
Sponsor's protocol ID
HLX15-SC-NDMM-001
Status last verified
Sep 2026
First submitted
27 Feb 2026
Last updated
24 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HLX15-SC-Rd and US-DARZALEX FASPRO®-Rd in people with Multiple Myeloma (MM), run by Shanghai Henlius Biotech at 84 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in China, United States, Serbia, Georgia, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yinping Zhong (+86-13983654553, Yinping_Zhong@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pharmacokinetic (PK) similarity (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07477587.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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Clinical Trial NCT07477587 | AzTrials