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A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL)

Last Updated   May 14, 2025

Want to learn how to participate in this trial?

80948543LYM1002

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 1
  • Sites
    10 Sites
  • Status
    Recruiting

SUMMARY

The purpose of this study is to determine the recommended phase 2 regimen (RP2R) for JNJ-80948543 in combination with JNJ-75348780 (Part 1: Dose Escalation) and to further assess the safety of JNJ-80948543 at the RP2R in combination with JNJ-75348780 (Part 2: Dose Expansion).

CONDITIONS

  • Lymphoma, Non-Hodgkin

ELIGIBILITY


Inclusion Criteria:

* Histologic documentation of diffuse large B-cell lymphoma (DLBCL), including high-grade B-cell lymphoma and DLBCL arising from indolent lymphoma. All participants must have received at least 2 prior lines of therapy
* Participants must have measurable disease as defined by the appropriate disease response criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Hematologic laboratory parameters must meet the required criterias and the values must be without a transfusion or growth factors for at least 7 days prior to the first dose of study drug
* Participants of childbearing potential must have a negative highly sensitive serum pregnancy test (beta (β)-human chorionic gonadotropin) at screening and within 24 hours before the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study


Exclusion Criteria:

* Known active central nervous system involvement (CNS) or leptomeningeal involvement
* Prior solid-organ transplantation
* Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug
* Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade <= 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be Grade 2)
* Clinically significant pulmonary compromise defined as the need for supplemental oxygen to maintain adequate oxygenation
* Evidence of clinically significant and/or symptomatic infection (viral, bacterial, or fungal) at the time of study drug initiation. Anti-microbial treatment for infection must be discontinued at least 7 days before the first dose of study drug


Inclusion Criteria:

* Histologic documentation of diffuse large B-cell lymphoma (DLBCL), including high-grade B-cell lymphoma and DLBCL arising from indolent lymphoma. All participants must have received at least 2 prior lines of therapy
* Participants must have measurable diseas

More...

DETAILS

LOCATIONS

Locations in:
Australia, Spain, Taiwan, United Kingdom
Country (4) City or Province (10) Status
Australia Fitzroy St Vincents Hospital Melbourne
RECRUITING
Australia North Ryde Macquarie University Hospital
RECRUITING
Spain Barcelona Hosp. Clinic de Barcelona
RECRUITING
Spain Madrid Hosp. Univ. 12 de Octubre
RECRUITING
Taiwan Taichung China Medical University Hospital
RECRUITING
Taiwan Taipei City National Taiwan University Hospital
RECRUITING
Australia Concord Concord Hospital
RECRUITING
Spain Barcelona Hosp Univ Vall D Hebron
RECRUITING
Spain Madrid Hosp. Gral. Univ. Gregorio Maranon
RECRUITING
United Kingdom Leicester University Hospitals Of Leicester Nhs Trust
RECRUITING
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Geo Locations

-37.79839, 144.97833

-33.79677, 151.12436

41.38879, 2.15899

40.4165, -3.70256

24.1469, 120.6839

25.04776, 121.53185

-33.84722, 151.10381

41.38879, 2.15899

40.4165, -3.70256

52.6386, -1.13169

x
50

Indicates 50+ sites in this region: click to zoom in.

10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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