QLS4131 / Qilu Pharma - LARVOL DELTA

BCMA/GPRC5D Trispecific Antibody Treatment for Newly Diagnosed Amyloidosis (AL-004) (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P2 trial • Amyloidosis

QLS4131-201: A Phase Ib Study of QLS4131 in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=108 | Terminated | Sponsor: Qilu Pharmaceutical Co., Ltd. | Recruiting ➔ Terminated

Trial termination • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

QLS4131 Combination Therapy in Malignant Plasma Cell Neoplasms (clinicaltrials.gov) - P2 | N=162 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology • Plasmacytoma

QLS4131, a proprietary T cell engager targeting both BCMA and GPRC5D for the treatment of multiple myeloma (AACR 2025) - P1 | "QLS4131 demonstrated a higher affinity for MM tumor cell lines when compared to JNJ-79635322, which is a clinical stage TCE targeting both BCMA and GPRC5D developed by Janssen Research & Development. In conclusion, the excellent efficacy, favorable PK, and safety profile support the potential of QLS4131 as a novel therapeutic agent to address the significant unmet needs in multiple myeloma. A Phase 1 dose-escalating study of QLS4131 in multiple myeloma is currently underway (NCT06500507)."

IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • GPRC5D • IL6

QLS4131, a next-generation GPRC5D×BCMA×CD3 trispecific T-cell engager, in patients with relapsed/refractory multiple myeloma (RRMM): Initial results of a first-in-human Phase Ⅰa study (ASH 2025) - P1 | "Preliminary dose-escalation data of QLS4131 in patients with RRMM demonstrated tolerable toxicity withno DLT observed, and relatively lower incidence of GPRC5D-related AEs compared with published datafrom competitors (eg. JNJ-79635322). Primary efficacy data showed positive response observed even atlow-dose levels."

Clinical • First-in-human • P1 data • Trispecific • Hematological Disorders • Hematological Malignancies • Multiple Myeloma

A Phase Ib Study of QLS4131 in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=108 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study of QLS4131 in Patients With Recurrent or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology