QLS2313 / Qilu Pharma - LARVOL DELTA

A Phase I Trial of QLS2313 Injection in Relapsed/Refractory Hematological Malignancies (clinicaltrials.gov) - P1 | N=124 | Sponsor: Qilu Pharmaceutical Co., Ltd.

First-in-human • Trial initiation date • Hematological Malignancies • Lymphoma • Oncology

QLS2313, a CD79b/CD20 tri-specific T cell engager with dual-targeting strategy developed as a new therapeutics for the treatment of DLBCL (AACR 2026) - "In vitro, QLS2313 exhibited higher affinity for DLBCL cell lines than JNJ-80948543 (a clinical-stage CD79b/CD20 TCE from Janssen) while demonstrating significantly lower affinity for primary human T cells and Jurkat cells compared to JNJ-80948543 and FDA-approved CD20/CD3 bi-specifics (mosunetuzumab and glofitamab). QLS2313 was well tolerated in a transgenic mice (QW × 4) GLP toxicity study, with the highest non-severely toxic dose (HNSTD) at 30 mg/kg for both intravenous and subcutaneous administration. In conclusion, QLS2313 show superior efficacy, favorable pharmacokinetics and safety profile, which support the clinical development of this novel therapy for DLBCL treatment."

Trispecific • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD79B • IL6