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)

Active, enrolled Phase 1 Last updated 13 April 2026

What this trial tests

Phase 1 trial testing JNJ-80948543 in Lymphoma, Non-Hodgkin in 167 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

18 August 2022

Primary endpoint
31 October 2025

30 July 2027

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	167
Start date	18 August 2022
Primary completion	31 October 2025
Estimated completion	30 July 2027
Sites	29 locations across Denmark, France, Japan, Israel, Poland, Australia, China, United States

Drugs / interventions tested

• JNJ-80948543 — full drug profile →

Conditions studied

• Lymphoma, Non-Hodgkin — all drugs for Lymphoma, Non-Hodgkin →
• Leukemia, Lymphocytic, Chronic, B-Cell — all drugs for Leukemia, Lymphocytic, Chronic, B-Cell →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

18 and older, any sex, with Lymphoma, Non-Hodgkin or Leukemia, Lymphocytic, Chronic, B-Cell. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bi- and trispecific immune cell engagers for immunotherapy of hematological malignancies.
   Tapia-Galisteo A, Álvarez-Vallina L, Sanz L. · · 2023 · cited 87× · PMID 37501154 · DOI 10.1186/s13045-023-01482-w
2. Logic-gated and contextual control of immunotherapy for solid tumors: contrasting multi-specific T cell engagers and CAR-T cell therapies.
   Nolan-Stevaux O, Smith R. · · 2024 · cited 29× · PMID 39606234 · DOI 10.3389/fimmu.2024.1490911
3. Stepping forward: T-cell redirecting bispecific antibodies in cancer therapy.
   Qin X, Ning W, Liu H, Liu X, et al · · 2024 · cited 28× · PMID 38828136 · DOI 10.1016/j.apsb.2024.03.027
4. Bi- and Tri-specific antibodies in non-Hodgkin lymphoma: current data and perspectives.
   Abou Dalle I, Dulery R, Moukalled N, Ricard L, et al · · 2024 · cited 23× · PMID 38272863 · DOI 10.1038/s41408-024-00989-w
5. Therapeutic antibodies in oncology: an immunopharmacological overview.
   Toledo-Stuardo K, Ribeiro CH, González-Herrera F, Matthies DJ, et al · · 2024 · cited 10× · PMID 39358613 · DOI 10.1007/s00262-024-03814-2
6. RNA-sequencing based first choice of treatment and determination of risk in multiple myeloma.
   Emde-Rajaratnam M, Beck S, Benes V, Salwender H, et al · · 2023 · cited 10× · PMID 38035078 · DOI 10.3389/fimmu.2023.1286700
7. Bispecific Antibodies for Lymphoid Malignancy Treatment.
   Bisio M, Legato L, Fasano F, Benevolo Savelli C, et al · · 2024 · cited 4× · PMID 39796723 · DOI 10.3390/cancers17010094
8. The landscape of T-cell engagers for the treatment of follicular lymphoma.
   Rivas-Delgado A, Landego I, Falchi L. · · 2024 · cited 2× · PMID 39398477 · DOI 10.1080/2162402x.2024.2412869