Clinical Trial: 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)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | Janssen Research & Development, LLC |
| Information Provided By: | Janssen Research & Development, LLC |
| Last Update Posted: | 2026-09-28 |
Study Overview
Brief 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
Conditions
Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
Intervention / Treatment
- Drug: JNJ-80948543
Other Study ID Numbers
- CR109174
- 2022-000685-18
- 80948543LYM1001
- 2023-504187-42-00
- 2023
Start Date (Actual)
2022-08-18
Primary Completion Date (Actual)
2025-10-31
Study Completion Date (Estimated)
2027-07-30
Enrollment (Actual)
167
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Janssen Research & Development, LLC |
| Information Provided By: | Janssen Research & Development, LLC |
| Last Update Posted: | 2026-09-28 |
Study Overview
Brief 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
Conditions
Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
Intervention / Treatment
- Drug: JNJ-80948543
Other Study ID Numbers
- CR109174
- 2022-000685-18
- 80948543LYM1001
- 2023-504187-42-00
- 2023
Start Date (Actual)
2022-08-18
Primary Completion Date (Actual)
2025-10-31
Study Completion Date (Estimated)
2027-07-30
Enrollment (Actual)
167
Study Type
Interventional
Phase
Phase 1