MRG001 / Lepu Biopharma - LARVOL DELTA

CD20-directed antibody-drug conjugates in non-hodgkin lymphoma: translating preclinical promise into clinical reality. (PubMed, J Hematol Oncol) - "Despite the paradigm-shifting success of anti-CD20 monoclonal antibodies like rituximab, limitations such as antigen loss, impaired host immune effector functions, and resistance remain key challenges in non-Hodgkin lymphoma (NHL). This review provides a focused analysis of clinical- and preclinical-stage CD20-directed ADCs, examining how innovative design strategies-including cleavable linkers, membrane-permeable payloads (e.g., MMAE), site-specific conjugation, and novel platforms such as extracellular drug conjugates (EDCs) and immune-stimulating antibody conjugates (ISACs)-are being developed to circumvent the internalization barrier. We critically analyze clinical progress (MRG001 and TRS005), preclinical innovations, and future directions for translating the promise of CD20-directed ADCs into clinical reality for patients with NHL."

Journal • Preclinical • Review • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

The preliminary results of MRG001-C002: A phase II Study of MRG001 combined with Orelabrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) (ASH 2025) - "Phase II results show that MRG001 combined with Orelabrutinib had clinically encouragingantitumor activity in pts with R/R DLBCL. Additionally, the safety profile was manageable, and ptstolerated treatment well. The trial is still ongoing."

Clinical • P2 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • IL2

A Phase Ib Open-Label Study of MRG001 in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) (ASH 2023) - P1 | "Phase Ib results show that MRG001 had clinically meaningful antitumor activity in patients with R/R DLBCL who progressed after multiple lines of therapy. Additionally, the safety profile was manageable and patients tolerated treatment well. Clinical trial information: NCT05155839."

Clinical • P1 data • Anemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology

A Dose Escalation Phase Ia Study of Anti-CD20 Antibody Drug Conjugate, MRG001 in Relapsed/Refractory Advanced Non-Hodgkin Lymphom (ASH 2021) - "In preclinical studies, MRG001 demonstrated significant tumor growth inhibition in rituximab-resistant non-Hodgkin's lymphoma (NHL) models. The dose escalation study of MRG001 has shown manageable safety profiles and encouraging preliminary antitumor activity in patients with NHL. Based on the safety, tolerability, and pharmacokinetic parameters of MRG001, 1.8 mg/kg was determined to be the RP2D and further investigation of MRG001 in patients with NHL is warranted."

P1 data • Diffuse Large B Cell Lymphoma • Dyslipidemia • Hematological Disorders • Hematological Malignancies • Hypertension • Leukopenia • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia

Safety and Preliminary Efficacy Study of MRG001 in Patients With Non-Hodgkin Lymphoma (NHL) (clinicaltrials.gov) - P1; N=108; Recruiting; Sponsor: Shanghai Miracogen Inc.

Clinical • New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology