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ACTIVE NOT RECRUITING
NCT05424822
PHASE1

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)

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D\[s\]), optimal dosing schedule(s) and route(s) of administration of JNJ-80948543 in Part A (Dose Escalation) and to further characterize the safety of JNJ-80948543 at the putative RP2D(s) in Part B (Cohort Expansion).

Official title: A Phase 1, First-in-human Study of JNJ-80948543, a T-cell Redirecting Antibody, in Participants With NHL and CLL

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

167

Start Date

2022-08-18

Completion Date

2027-07-30

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

JNJ-80948543

JNJ-80948543 will be administered as SC or IV injection.

Locations (29)

City of Hope

Duarte, California, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Texas Transplant Institute

San Antonio, Texas, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Macquarie University Hospital

Macquarie University, Australia

The Alfred Hospital

Melbourne, Australia

Linear Clinical Research Ltd

Nedlands, Australia

Scientia Clinical Research

Randwick, Australia

Chongqing University Cancer Hospital

Chongqing, China

Sun Yat Sen University Cancer Center

Guangzhou, China

Tianjin cancer hospital

Tianjin, China

Union Hospital Tongji Medical College of Huazhong University of Science and Technology

Wuhan, China

Rigshospitalet

Copenhagen, Denmark

Odense University Hospital

Odense, Denmark

CHRU de Lille Hopital Claude Huriez

Lille, France

Institut Curie

Paris, France

Institut de Cancerologie Strasbourg Europe ICANS

Strasbourg, France

Institut Universitaire du cancer de Toulouse-Oncopole

Toulouse, France

Carmel Medical Center

Haifa, Israel

Hadassah Medical Center

Jerusalem, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

National Cancer Center Hospital East

Kashiwa, Japan

Aichi Cancer Center

Nagoya, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz

Gdansk, Poland

Aidport Sp z o o

Skorzewo, Poland