QL2109 (daratumumab/hyaluronidase biosimilar) / Qilu Pharma - LARVOL DELTA

Combination Therapy with QLS32015 for the Treatment of Multiple Myeloma (ChiCTR) - P2 | N=160 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Institute of Hematology

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Phase I randomized, double-blind, parallel study to compare pharmacokinetics, safety, and immunogenicity of QL2109 with daratumumab and hyaluronidase-fihj in healthy male participants (ESMO 2025) - P1 | "Conclusions This study demonstrated the PK similarity between QL2109 and originator drug, as well as comparable safety profile and immunogenicity. QL2109 is a promising biosimilar of daratumumab (DARZALEX FASPRO®) and is being studied in phase 3 trial."

Clinical • P1 data • PK/PD data • Hematological Malignancies • Multiple Myeloma • Oncology

Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

QL2109-101: A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy Adults (clinicaltrials.gov) - P1 | N=228 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology

To Evaluate the Efficacy and Safety of QL2109 and DARZALEX FASPRO® in Multiple Myeloma (clinicaltrials.gov) - P3 | N=284 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P3 trial • Hematological Malignancies • Multiple Myeloma • Oncology

A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy Adults (clinicaltrials.gov) - P1 | N=228 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1 trial • Oncology