NCT05424822

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)

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Lymphoma, Non-Hodgkin
• Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Type	Name	Description
DRUG	JNJ-80948543	JNJ-80948543 will be administered as SC or IV injection.

Timeline

• Start date: 2022-08-18
• Primary completion: 2025-10-31
• Completion: 2027-07-30
• First posted: 2022-06-21
• Last updated: 2026-04-13

Locations

29 sites across 8 countries: United States, Australia, China, Denmark, France, Israel, Japan, Poland

Regulatory

• FDA-regulated drug study