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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
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
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