F182112 / Lunan Pharma - LARVOL DELTA

CAREMM-009: F182112 in Combination With Isatuximab and Lenalidomide for the Treatment of Patients With Newly Diagnosed Multiple Myeloma (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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

Phase 1 Study of F182112 in Relapsed/Refractory Autoimmune Hemolytic Anemia (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P1 trial • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immunology

A PHASE II STUDY OF F182112 IN COMBINATION WITH DARATUMUMAB AND POMALIDOMIDE IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (EHA 2026) - P1, P2 | "Eligible patients had 1-3 prior lines of therapy (LOT), including a proteasome inhibitor (PI) and lenalidomide. Figure 1. Study design (A) and Response rate (B) in RRMM patients treated with F-DP."

Clinical • Combination therapy • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Leukopenia • Multiple Myeloma • Neutropenia • Pneumonia • Respiratory Diseases • Thrombocytopenia

A Multicenter, Randomized, Open-label, Parallel-group, Controlled, Superiority Phase III Clinical Study Comparing the Efficacy and Safety of F182112 Versus Standard of Care in Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P3 | N=261 | Recruiting | Sponsor: Shandong New Time Pharmaceutical Co., LTD

Head-to-Head • New P3 trial • Hematological Malignancies • Multiple Myeloma • Oncology

A Phase 1 First-in-Human Monotherapy Study of F182112, a B-Cell Maturation Antigen (BCMA)-CD3 Bispecific Antibody, in Patients with Relapsed or Refractory Multiple Myeloma (ASH 2023) - P1 | "F182112 in patients with RRMM is well tolerated with preliminary antitumor activity and a favorable PK profile in patients,supporting further evaluation."

Clinical • First-in-human • Monotherapy • P1 data • Anemia • Hematological Disorders • Hematological Malignancies • Leukopenia • Multiple Myeloma • Neutropenia • Oncology

A PHASE I DOSE-ESCALATION AND COHORT-EXPANSION STUDY OF F182112, BCMA X CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (EHA 2025) - P1 | "This trial demonstrated that F182112 had manageable safety and promising clinical activity (particularly at higher dose levels) in heavily pretreated RRMM patients, providing a novel immunotherapy option for this patient population."

Clinical • P1 data • Anemia • Hematological Disorders • Hematological Malignancies • Inflammation • Leukopenia • Multiple Myeloma • Neutropenia • Oncology

Bispecific antibodies targeting BCMA, GPRC5D, and FcRH5 for multiple myeloma therapy: latest updates from ASCO 2023 Annual Meeting. (PubMed, J Hematol Oncol) - "Teclistamab was approved for relapsed/refractory MM therapy in 2022, while elranatamab, linvoseltamab, F182112, talquetamab, and cevostamab are currently undergoing clinical trials. This study summarizes several latest reports on bsAbs for the treatment of MM from the ASCO 2023 Annual Meeting."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

Results from a first-in-human phase I study of F182112, a B-cell maturation antigen (BCMA)-CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma. (ASCO 2023) - P1 | "F182112 provides a novel immunotherapy approach for the treatment of Relapsed/ Refractory Multiple Myeloma that may yield improved clinical efficacy in heavily pretreated pts. Clinical trial information: NCT04984434."

Clinical • P1 data • Anemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Immune Modulation • Leukopenia • Multiple Myeloma • Neutropenia • Oncology • Transplantation

Phase 1 Study of F182112 in Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=68; Recruiting; Sponsor: Shandong New Time Pharmaceutical Co., LTD

New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology