RecruitingPhase 1NCT07308132

A Study of JNJ-95566692 in Participants With Non-Hodgkin Lymphoid Malignancies

A Phase 1, First-in-Human Study of a Novel CD79bxCD20xCD3 Trispecific Antibody in B-Cell Non-Hodgkin Lymphoid Malignancies (NHLs)

Sponsor

Janssen Research & Development, LLC

Enrollment

340 participants

Start Date

Jan 20, 2026

Study Type

INTERVENTIONAL

Conditions

Lymphoma, Non-Hodgkin

Summary

The purpose of this study is to determine the putative recommended Phase 2 doses (RP2Ds) and optimal dose schedule(s) for JNJ-95566692 as a single agent (Arm A) and in combination with JNJ-87801493 (Arm B) and for JNJ-95566692 with or without JNJ-87801493 with various standard of care (SOC) regimens (Arms C-G) in Part 1: Dose Escalation part of the study. Part 2: Dose Expansion part of the study will further characterize the safety.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a new experimental drug called JNJ-95566692 for people with B-cell non-Hodgkin lymphomas and related blood cancers that have returned after prior treatment or stopped responding. **You may be eligible if...** - You have a confirmed B-cell non-Hodgkin lymphoid malignancy (such as certain lymphomas) per the 2022 WHO classification - Your cancer has relapsed or is refractory (not responding) and no better approved options are available - You have received at least 2 prior lines of therapy, including an anti-CD20 antibody-based chemotherapy regimen - OR you have had at least one prior treatment but are not eligible for or cannot access standard second-line therapies like CAR-T **You may NOT be eligible if...** - You have adequate access to and eligibility for standard second-line therapies - Your cancer does not match the required diagnosis - You have not received the required prior treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJNJ-95566692

JNJ-95566692 will be administered subcutaneously.

DRUGJNJ-87801493

JNJ-87801493 will be administered subcutaneously.

DRUGloncastuximab tesirine

Loncastuximab tesirine will be administered intervenously.

DRUGLenalidomide

Lenalidomide will be administered orally.

DRUGRituximab

Rituximab will be administered intravenously and may be administered subcutaneously after the first administration.

DRUGGemcitabine

Gemcitabine will be administered intravenously.

DRUGOxaliplatin

Oxaliplatin will be administered intravenously.

DRUGCyclophosphamide

Cyclophosphamide will be administered intravenously.

DRUGDoxorubicin

Doxorubicin will be administered intravenously.

DRUGVincristine

Vincristine will be administered intravenously.

DRUGPrednisone

Prednisone will be administered orally.

DRUGPolatuzumab vedotin

Polatuzumab vedotin will be administered intravenously.

Locations(19)

Monash Medical Centre

Clayton, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

Macquarie University Hospital

North Ryde, Australia

Scientia Clinical Research

Randwick, Australia

UZ Antwerpen

Edegem, Belgium

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

Liège, Belgium

Hopital Claude Huriez

Lille, France

CHU Pitie Salpetriere

Paris, France

CHU Lyon Sud

Pierre-Bénite, France

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp. Clinic de Barcelona

Barcelona, Spain

Hosp Univ Fund Jimenez Diaz

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp Univ Hm Sanchinarro

Madrid, Spain

SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi

Ankara, Turkey (Türkiye)

Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi

Ankara, Turkey (Türkiye)

Memorial Antalya Hastanesi Faz 1 Klinik Arastirma Merkezi

Antalya, Turkey (Türkiye)

Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi

Istanbul, Turkey (Türkiye)

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NCT07308132

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