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RECRUITING
NCT07308132
PHASE1

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

340

Start Date

2026-01-20

Completion Date

2029-10-31

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

DRUG

JNJ-95566692

JNJ-95566692 will be administered subcutaneously.

DRUG

JNJ-87801493

JNJ-87801493 will be administered subcutaneously.

DRUG

loncastuximab tesirine

Loncastuximab tesirine will be administered intervenously.

DRUG

Lenalidomide

Lenalidomide will be administered orally.

DRUG

Rituximab

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

DRUG

Gemcitabine

Gemcitabine will be administered intravenously.

DRUG

Oxaliplatin

Oxaliplatin will be administered intravenously.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered intravenously.

DRUG

Doxorubicin

Doxorubicin will be administered intravenously.

DRUG

Vincristine

Vincristine will be administered intravenously.

DRUG

Prednisone

Prednisone will be administered orally.

DRUG

Polatuzumab 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)