A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Nov 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called JNJ-87801493, which is being tested in combination with another type of therapy known as T-cell engagers. The goal is to find out if this combination is safe and to determine the best dose to use for future studies in patients with B-cell Non-Hodgkin Lymphoma (NHL), a type of cancer that affects the lymphatic system. The trial is currently looking for participants who have had their cancer come back after treatment or who have not responded to previous therapies.

To be eligible for this trial, participants need to have a confirmed diagnosis of B-cell NHL and measurable signs of their disease. They should also have a good performance status, meaning they can carry out daily activities with minimal difficulty. Participants must not have had certain previous treatments or other serious health issues that could interfere with the study. If someone joins the trial, they can expect to receive the study drug and regular check-ups to monitor their health and cancer response. Overall, this study aims to provide new options for patients facing challenging forms of non-Hodgkin lymphoma.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologic documentation of B-cell NHL. All participants in part 1 must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment. In Part 2, participants with diffuse large B-cell lymphoma (DLBCL) or other high-grade B cell lymphoma and participants with transformed lymphoma from low-grade B cell malignancies who relapsed or failed to respond to only one prior systemic treatment regimen can be included
• • Part 1 participants must have evaluable or measurable disease and Part 2 participants must have measurable disease; all as defined by the Lugano criteria for non-Hodgkin lymphoid malignancies (NHL) and the international workshop on Waldenstrom's Macroglobulinemia (IWWM-6) for WM
• • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• • 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 72 hours of 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. CNS involvement may be allowed in specific cohorts as determined by the Study Evaluation Team (SET)
• • Prior solid-organ transplantation
• • Prior treatment with JNJ-80948543 and/or JNJ-75348780. In addition, history of known allergies, hypersensitivity, or intolerance to either JNJ-80948543, JNJ-75348780, or JNJ-87801493 or its excipients
• • Chemotherapy, targeted therapy, or immunotherapy within 2 weeks before the first dose of study treatment. For investigational agents where the half-life is known, there should be a treatment-free window of at least 2 weeks or 5 half-lives. For checkpoint blockade therapy (example, anti-programmed cell death protein-1 \[anti-PD-1\]), a washout period of up to 6 weeks may be considered
• • Malignancy diagnosis other than the disease under study within 1 year prior to screening. Exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of first dose of the study drugs in the opinion of both the investigator and sponsor's medical monitor
• • Autoimmune or inflammatory disease requiring systemic corticosteroids or other immunosuppressive agents within 1 year prior to first dose of study treatment
• • Evidence of active viral, bacterial, or uncontrolled systemic fungal infection requiring systemic treatment within 7 days before the first dose of study treatment
• • Abnormal cardiac function