# 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

> **NCT07477587** · PHASE1 · NOT_YET_RECRUITING · sponsor: **Shanghai Henlius Biotech** · enrollment: 258 (estimated)

## Conditions studied

- Multiple Myeloma (MM)

## Interventions

- **DRUG:** HLX15-SC-Rd
- **DRUG:** US-DARZALEX FASPRO®-Rd

## Key facts

- **NCT ID:** NCT07477587
- **Lead sponsor:** Shanghai Henlius Biotech
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-05-27
- **Primary completion:** 2027-05-25
- **Final completion:** 2028-02-22
- **Target enrollment:** 258 (ESTIMATED)
- **Last updated:** 2026-03-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07477587

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07477587, "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". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT07477587. Licensed CC0.

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