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NCT07477587 · ClinicalTrials.gov registry record · Phase 1
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, sponsored by Shanghai Henlius Biotech.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 258
- Enrollment target
NCT07477587 is a Phase 1 study that is actively recruiting participants, run by Shanghai Henlius Biotech. The registered enrollment target is 258 participants.
The verdict
NCT07477587, a Phase 1 study, is actively recruiting participants, sponsored by Shanghai Henlius Biotech.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 258 participants
- Enrollment target
Study 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. 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).
Interventions
- DRUG HLX15-SC-Rd
- DRUG US-DARZALEX FASPRO®-Rd
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2026-05-27 |
| Est. Completion | 2028-02-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07477587
The ClinicalTrials.gov registry entry for NCT07477587 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 258 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shanghai Henlius Biotech, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which HLX15-SC-Rd is the first listed.
NCT07477587 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07477587 about?
NCT07477587 is a clinical study titled "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". 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 wh...
What is the current status of trial NCT07477587?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 258 participants. The study started on 2026-05-27. Estimated completion is 2028-02-22.
What interventions are being tested in trial NCT07477587?
The interventions under investigation include: HLX15-SC-Rd (DRUG), US-DARZALEX FASPRO®-Rd (DRUG).
Who is sponsoring clinical trial NCT07477587?
This trial is sponsored by Shanghai Henlius Biotech, which has 8 total clinical trials registered on ClinicalTrials.gov.
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