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)
JNJ-80948543: JNJ-80948543 will be administered as subcutaneous (SC) or intravenous (IV) injection.
JNJ-75348780: JNJ-75348780 will be administered as SC injection.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Number of Participants with Dose-limiting Toxicity (DLT) — Up to 1 year and 10 months Number of participants with DLT will be reported. DLTs are defined as any of the treatment-related toxicities: any toxicity that would require discontinuation of treatment; Fatal toxicity; Non-hematologic toxicity (Grade 3 toxicity or higher with exceptions); and Hematologic Toxicity (Grade 4 neutrophil count decrease; Grade 4 febrile neutropenia; Grade 3 febrile neutropenia that does not recover with best supportive care within 7 days; Grade 4 platelet count decrease for \>=7 days or Grade \>3 with Grade \>=2 bleeding; Grade 4 anemia).
Number of Participants with Adverse Events (AEs) — Up to 1 year and 10 months An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Trial sites (11)
Facility
City
Region
Status
Concord Hospital
Concord
Australia
St Vincents Hospital Melbourne
Fitzroy
Australia
Macquarie University Hospital
North Ryde
Australia
Hosp Univ Vall D Hebron
Barcelona
Spain
Hosp. Clinic de Barcelona
Barcelona
Spain
Inst. Cat. Doncologia-H Duran I Reynals
L'Hospitalet de Llobregat
Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid
Spain
Hosp. Univ. 12 de Octubre
Madrid
Spain
China Medical University Hospital
Taichung
Taiwan
National Taiwan University Hospital
Taipei
Taiwan
University Hospitals Of Leicester Nhs Trust
Leicester
United Kingdom
More Janssen Research & Development, LLC trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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