HLX15 Clinical Trials (2026): 3 Studies for Multiple Myeloma & Multiple Myeloma (MM)
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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3 HLX15 clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 3 indications (including Multiple Myeloma & Multiple Myeloma (MM)) and 816 total planned enrollment. 1 Phase 3 HLX15 trial are listed. 2 HLX15 clinical trials are actively recruiting at 9 U.S. sites across 5 states. Most recent activity: NCT07477587 (Feb 2028).
Where to Participate: All HLX15 Trial Sites in the U.S. (9 sites across 5 states)
Every actively recruiting HLX15trial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| AR | Highlands Oncology Group, PA | Springdale72762 | NCT07477587 | Map |
| FL | Cancer Specialists of North Florida | Jacksonville32256 | NCT07477587 | Map |
| FL | D&H National Research Center | Margate33063 | NCT07477587 | Map |
| FL | Ocala Oncology Center | Ocala34474 | NCT07477587 | Map |
| FL | Florida Clinical Trials Group | Plantation33322 | NCT07477587 | Map |
| FL | Florida Clinical Trials Group | Tamarac33321 | NCT07477587 | Map |
| LA | Pontchartrain Cancer Center | Covington70433 | NCT07477587 | Map |
| TX | Oncology Consultants (P1 Trials -Exigent Network) | Houston77030 | NCT07477587 | Map |
| WA | American Oncology Network Vista Oncology Division / Physician partner associate | Olympia98506 | NCT07477587 | Map |
HLX15 clinical trials at a glance: phase × recruitment status
| Phase | recruiting | completed | not yet recruiting | Total |
|---|---|---|---|---|
| P1 | 1 | 1 | 2 | |
| P3 | 1 | 1 |
Recruiting HLX15 clinical trials (2)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| 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 | P1 | Multiple Myeloma (MM) | 258 | May 2026 |
| NCT06895512 | A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma | P3 | Newly Diagnosed Multiple Myeloma | 386 | Apr 2025 |
HLX15 clinical trials by indication
Multiple Myeloma (MM) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07477587 | — | P1 | recruiting | 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 |
Newly Diagnosed Multiple Myeloma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06895512 | — | P3 | not yet recruiting | A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma |
Multiple Myeloma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05679258 | — | P1 | completed | A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects |
All HLX15 trials (3)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| 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 | P1 | recruiting | 258 | Shanghai Henlius Biotech | May 2026 | |
| NCT06895512 | A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma | P3 | not yet recruiting | 386 | Shanghai Henlius Biotech | Apr 2025 | |
| NCT05679258 | A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects | P1 | completed | 172 | Shanghai Henlius Biotech | Jan 2023 |
HLX15 clinical trials: frequently asked questions
- How many HLX15 clinical trials are there?
- 3 HLX15 clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 1 is actively recruiting participants. 1 is marked completed.
- Are HLX15 clinical trials recruiting in 2026?
- Yes — 1 HLX15 trial is actively recruiting in 2026, with 9 U.S. sites across 5 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is HLX15 being studied for?
- HLX15 is being studied for Multiple Myeloma, Multiple Myeloma (MM), Newly Diagnosed Multiple Myeloma. The trials are grouped by indication on this page.
- What phase is HLX15 in?
- HLX15 clinical trials span 1 Phase 3, 2 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors HLX15 clinical trials?
- The lead sponsor across the most HLX15 trials is Shanghai Henlius Biotech. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming HLX15as an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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