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)

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Oct 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called JNJ-80948543, which is being tested in combination with another drug, JNJ-75348780, for patients with a type of cancer known as relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-Cell NHL). The goal is to find the best way to use these medications together and to ensure they are safe for patients. This trial is currently looking for participants aged 65 and older who have already had at least two other treatments for their lymphoma and have measurable signs of their disease.

Eligible participants will need to have a specific type of lymphoma and meet certain health criteria, including having a good overall performance status, which means they are generally able to care for themselves. They will also undergo regular health checks throughout the study. If you are interested in joining, it’s important to know that certain health conditions and treatments may prevent participation, such as having recent infections or significant organ issues. Overall, this trial aims to explore new treatment options for patients who have not responded to previous therapies, and your involvement could contribute to important advancements in cancer care.

Gender

ALL

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