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)

NCT06660563 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 80948543LYM10022024-514176-41-00
• Study Type: interventional
• Target: 19
• Locations: 4 countries
• Sites: 11

Brief 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

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Dose-limiting Toxicity (DLT)

  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).

  Up to 1 year and 10 months

• Number of Participants with Adverse Events (AEs)

  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.

  Up to 1 year and 10 months

Secondary Outcomes (8)

• Serum Concentration of JNJ-80948543 and JNJ-75348780

  Up to 1 year and 10 months

• Area Under the Curve (AUCtau) for JNJ-80948543 and JNJ-75348780

  Up to 1 year and 10 months

• Maximum Serum Concentration (Cmax) for JNJ-80948543 and JNJ-75348780

  Up to 1 year and 10 months

• Time to Reach Cmax (Tmax) for JNJ-80948543 and JNJ-75348780

  Up to 1 year and 10 months

• Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543 and JNJ-75348780

  Up to 1 year and 10 months

Study Arms (1)

JNJ-80948543

EXPERIMENTAL

Participants will receive JNJ-80948543 in combination with JNJ-75348780 to determine the recommended phase 2 regimen (RP2R) in Part 1 (Dose escalation). JNJ-80948543 will be dosed in an escalation manner in combination with fixed doses of JNJ-75348780. In Part 2 (Dose expansion) participants will receive RP2R of JNJ-80948543 as determined in Part 1 in combination with JNJ-75348780.

Drug: JNJ-80948543; Drug: JNJ-75348780

Interventions

JNJ-80948543 DRUG

JNJ-80948543 will be administered as subcutaneous (SC) or intravenous (IV) injection.

JNJ-80948543

JNJ-75348780 DRUG

JNJ-75348780 will be administered as SC injection.

JNJ-80948543

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (11)

Concord Hospital

Concord, 2139, Australia

Location

St Vincents Hospital Melbourne

Fitzroy, 3065, Australia

Location

Macquarie University Hospital

North Ryde, 2109, Australia

Location

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Hosp. Clinic de Barcelona

Barcelona, 08036, Spain

Location

Inst. Cat. Doncologia-H Duran I Reynals

L'Hospitalet de Llobregat, 08908, Spain

Location

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

University Hospitals Of Leicester Nhs Trust

Leicester, Le1 5ww, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): September 7, 2026
• Study Completion (Estimated): September 21, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

ES (5); TW (2); AU (3); GB (1)