Testing a new treatment for B-cell Non-Hodgkin Lymphoma

A Phase 1, First-in-human Study of JNJ-87801493 in Combination With CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoid Malignancies (NHLs)

This study is testing a new treatment combining JNJ-87801493 with T-cell engagers to see if it can help people with B-cell Non-Hodgkin Lymphoma who have run out of other options.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 235 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Janssen Research & Development, LLC (Industry-sponsored)
• Drugs / interventions: Chemotherapy, immunotherapy
• Locations: 12 sites (Heidelberg and 11 other locations)
• Trial ID: NCT06139406 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of JNJ-87801493 in combination with T-cell engagers for patients with B-cell Non-Hodgkin Lymphoma (NHL). It consists of two parts: the first part focuses on dose escalation to determine the recommended phase 2 regimen, while the second part assesses the safety of the recommended regimen in a larger group of participants. The study aims to provide a new treatment option for patients with relapsed or refractory NHL who have limited alternatives.

Who should consider this trial

Good fit: Ideal candidates include individuals with relapsed or refractory B-cell NHL who have no other approved therapies available.

Not a fit: Patients with low-grade B-cell malignancies who have not relapsed or failed to respond to prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with difficult-to-treat B-cell Non-Hodgkin Lymphoma.

How similar studies have performed: Other studies have shown promise with similar approaches using T-cell engagers in treating lymphomas, indicating potential for success.

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

Where this trial is running

Heidelberg and 11 other locations

• Austin Hospital — Heidelberg, Australia (Recruiting)
• The Alfred Hospital — Melbourne, Australia (Recruiting)
• Linear Clinical Research Ltd — Nedlands, Australia (Recruiting)
• Scientia Clinical Research — Randwick, Australia (Recruiting)
• Rigshospitalet — Copenhagen, Denmark (Recruiting)
• Odense University Hospital — Odense, Denmark (Recruiting)
• Hadassah Medical Center — Jerusalem, Israel (Recruiting)
• Sourasky (Ichilov) Medical Center — Tel Aviv, Israel (Recruiting)
• Hosp Univ Vall D Hebron — Barcelona, Spain (Recruiting)
• Hosp Univ Fund Jimenez Diaz — Madrid, Spain (Recruiting)
• Clinica Univ. de Navarra — Pamplona, Spain (Recruiting)
• Hosp Clinico Univ de Salamanca — Salamanca, Spain (Recruiting)

Study contacts

• Study coordinator: Study Contact

Conditions Lymphoma, Non-Hodgkin