JNJ-8543 / J&J - LARVOL DELTA

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

Characterization of JNJ-80948543 a novel CD79bxCD20xCD3 trispecific antibody for B-cell non-Hodgkin lymphoma. (PubMed, Haematologica) - P1 | "Collectively, the selectivity, potent cytotoxicity, tumor growth inhibition, and favorable cytokine profile of JNJ-80948543 supports its clinical development. Phase 1 clinical trials are ongoing to evaluate JNJ-80948543 as a monotherapy (NCT05424822) and in combination with a co-stimulatory bispecific antibody (NCT06139406) in patients with R/R B-NHL."

Journal • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD79B

A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL) (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jan 2026 ➔ Sep 2026

Trial primary completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of JNJ-80948543, a T-cell Redirecting CD79b x CD20 x CD3 Trispecific Antibody, in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov) - P1 | N=167 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jun 2026 ➔ Oct 2025

First-in-human • Trial primary completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2

A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL) (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Sep 2026 ➔ Jan 2026

Trial primary completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer (clinicaltrials.gov) - P1 | N=70 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting | N=235 ➔ 70 | Trial completion date: Nov 2027 ➔ Aug 2026 | Trial primary completion date: Nov 2027 ➔ Jan 2026

Enrollment change • Enrollment closed • First-in-human • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

JNJ-87801493 (CD20xCD28), a Potential First-in-Class CD20 Targeted CD28 Costimulatory Bispecific Antibody, Enhances the Activity of B-Cell Targeting T-Cell Engagers in Preclinical Models (ASH 2024) - P1 | "In conclusion, our data establishes the preclinical activity of JNJ-87801493 and its impact on the in vitro and in vivo efficacy of TCEs through improved T-cell function. A clinical trial (NCT06139406) is underway to characterize the safety and clinical activity of JNJ-87801493 in combination with JNJ-80948543 in participants with previously treated B-cell NHL."

Preclinical • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD79B • CD80 • CD86

A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL) (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting | N=40 ➔ 19

Enrollment change • Enrollment closed • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of JNJ-80948543, a T-cell Redirecting CD79b x CD20 x CD3 Trispecific Antibody, in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov) - P1 | N=167 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2026 ➔ Jul 2027

Enrollment closed • Trial completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2

A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer (clinicaltrials.gov) - P1 | N=235 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jul 2026 ➔ Nov 2027

Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer (clinicaltrials.gov) - P1 | N=235 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=70 ➔ 235 | Trial completion date: Jul 2026 ➔ Nov 2027

Enrollment change • Trial completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL) (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Janssen Research & Development, LLC

Combination therapy • New P1 trial • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of JNJ-80948543, a T-cell Redirecting CD79b x CD20 x CD3 Trispecific Antibody, in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov) - P1 | N=220 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jul 2024 ➔ Jun 2026

Trial primary completion date • Trispecific • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2

Target malignant tumors! Johnson & Johnson’s trispecific antibody therapy approved for clinical use in China [Google translation] (jrj.com) - "According to the CDE official website, Johnson & Johnson Innovative Medicine's Class 1 new drug JNJ-80948543 injection has been approved for clinical use and is planned to be developed to treat lymphocytic malignant tumors. Public information shows that this is a new type of CD79b x CD20 x CD3 trispecific T cell redirecting antibody."

New trial • Hematological Malignancies • Oncology

A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting | Trial completion date: Jul 2028 ➔ Jul 2026

Combination therapy • Enrollment open • Trial completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of JNJ-80948543, a T-cell Redirecting CD79b x CD20 x CD3 Trispecific Antibody, in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2024 ➔ Oct 2026

Trial completion date • Trispecific • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2

A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer (clinicaltrials.gov) - P1 | N=70 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC

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

A Study of JNJ-80948543, a T-cell Redirecting CD79b x CD20 x CD3 Trispecific Antibody, in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jul 2024 ➔ Oct 2024

Trial completion date • Trispecific • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2

A Study of JNJ-80948543, a T-cell Redirecting CD79b x CD20 x CD3 Trispecific Antibody, in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jan 2025 ➔ Jul 2024 | Trial primary completion date: Jan 2025 ➔ Jul 2024

Trial completion date • Trial primary completion date • Trispecific • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2

Characterization of JNJ-80948543, a Novel CD79bxCD20xCD3 Trispecific T-Cell Redirecting Antibody for the Treatment of B-Cell Non-Hodgkin Lymphoma (ASH 2022) - "Taken together, JNJ-80948543 is a potential first-in-class trispecific antibody for the treatment of B‑NHL malignancies with high unmet medical needs. A Phase I dose-escalation study of JNJ-80948543 in patients with relapsed/refractory Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia (CLL) will be initiated."

IO biomarker • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD79B

Janssen presents preclinical data on JNJ-80948543 (Bioworld) - "Janssen Pharmaceutica NV reported on the company’s novel fully human immunoglobulin G1 CD79bxCD20xCD3 trispecific antibody JNJ-80948543, comprising an anti-CD3 ε single-chain variable fragment (scFv), an anti-CD20 scFv, and an anti-CD79b fragment antigen-binding (Fab) domain and an effector-silent Fc, designed to redirect T cells to treat patients whose disease no longer responds to previous lines of therapy."

Preclinical • Hematological Malignancies • Oncology

A Study of JNJ-80948543, a T Cell Redirecting Antibody, in Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2

A Study of JNJ-80948543, a T Cell Redirecting Antibody, in Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov) - P1 | N=180 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC

New P1 trial • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2