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)

Trial Title: 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)

NCT ID: NCT06660563

Condition: Lymphoma, Non-Hodgkin

Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: JNJ-80948543
Description: JNJ-80948543 will be administered as subcutaneous (SC) or intravenous (IV) injection.
Arm group label: JNJ-80948543

Intervention type: Drug
Intervention name: JNJ-75348780
Description: JNJ-75348780 will be administered as SC injection.
Arm group label: JNJ-80948543

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).

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: China Medical University Hospital

Address:
City: Taichung
Zip: 40447
Country: Taiwan

Status: Recruiting

Start date: November 5, 2024

Completion date: September 21, 2026

Lead sponsor:
Agency: Janssen Research & Development, LLC
Agency class: Industry

Source: Janssen Research & Development, LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06660563