Last reviewed · How we verify
HLX15
At a glance
| Generic name | HLX15 |
|---|---|
| Also known as | Recombinant anti-CD38 fully humanized monoclonal antibody injection |
| Sponsor | Shanghai Henlius Biotech |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- 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 (PHASE1)
- Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial (PHASE2)
- Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial (PHASE2)
- Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL) (PHASE2, PHASE3)
- MC210808 Venetoclax in Combination With Lenalidomide and Dexamethasone (Ven-Rd), Daratumumab and Dexamethasone (Ven-Dd), or Daratumumab-Lenalidomide-Dexamethasone (Ven-DRd) for the Treatment of Multiple Myeloma (PHASE1)
- Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study (PHASE1, PHASE2)
- Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for the Treatment of Relapsed Multiple Myeloma (PHASE1, PHASE2)
- 225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- HLX15 CI brief — competitive landscape report
- HLX15 updates RSS · CI watch RSS
- Shanghai Henlius Biotech portfolio CI