JNJ-95566692 alone or with JNJ-87801493 for relapsed or refractory B‑cell non‑Hodgkin lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, open‑label, two‑part study with dose escalation (Part 1) and dose expansion (Part 2) to determine recommended Phase 2 doses and characterize safety and clinical activity. Arm A administers JNJ‑95566692 as a single agent and Arm B gives JNJ‑95566692 in combination with JNJ‑87801493. Part 1 will identify the putative RP2D(s) and optimal dosing schedule(s), and Part 2 will further characterize safety and anti‑tumor activity at those dose(s). The trial is sponsored by Janssen and enrolling at Australian centers, with serial visits for dosing, safety monitoring, and tumor response assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* B-cell non-Hodgkin lymphoid malignancies (NHL) according to World Health Organization (WHO) 2022 and no other approved therapies available that would be more appropriate in the investigator's judgment. -Histologic documentation of the following large B-cell lymphomas: -diffuse large B-cell lymphoma not otherwise specified (NOS), -T-cell/histiocyte-rich large B-cell lymphoma, -diffuse large B-cell lymphoma/high grade B-cell lymphoma with MYC and BCL2 rearrangements, -large B-cell lymphoma with IRF4 rearrangement, -high grade B-cell lymphoma with 11q aberrations, -Epstein-Barr virus (EBV)-positive diffuse large B-cell lymphoma, -diffuse large B-cell lymphoma associated with chronic inflammation, -primary large B-cell lymphoma of immune privileged sites, -primary cutaneous diffuse large B-cell lymphoma-leg type , -primary mediastinal large B-cell lymphoma, -high-grade B-cell lymphoma NOS, -transformations of indolent B-cell lymphoma (For US sites). -Other B-cell NHL may be enrolled based on emerging data in specific cohorts as stipulated by study evaluation team (SET)
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Participants must have measurable disease as defined by the disease criteria (Lugano criteria)
* While on study treatment and for 3 months after the last dose of study treatment, a participant must: not breastfeed or become pregnant; not donate gametes (that is, eggs or sperm) or freeze for future use for the purposes of assisted reproduction; and wear an external condom; -Participants of childbearing potential must have a negative highly sensitive (for example, beta \[β\]-human chorionic gonadotropin) pregnancy test at screening and within 24 hours before the first dose of study treatment and agree to further pregnancy tests, -For Arm E ONLY: Practice 2 methods of reliable birth control simultaneously, including 1 highly effective form of contraception and 1 additional effective contraceptive method., -Participants on Arms C-G should also follow the pregnancy and contraception restrictions in the respective local corresponding product label

Exclusion Criteria:

* Known active central nervous system involvement (CNS) or leptomeningeal involvement
* Prior solid-organ transplantation
* Malignancy diagnosis other than the disease under study within 1 year prior to the first dose of the study treatment; 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 treatment in the opinion of both the investigator and sponsor's medical monitor
* Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (for example, methotrexate or tacrolimus) within 3 months prior to first dose of study treatment
* Toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (\<=) 1 (except alopecia, vitiligo, peripheral neuropathy, or Grade \<=2 endocrinopathies that are stable on hormone replacement)

Where it's running

• Monash Medical Centre
  Clayton, Australia Recruiting
• Peter MacCallum Cancer Centre
  Melbourne, Australia Recruiting
• Macquarie University Hospital
  North Ryde, Australia Recruiting
• Scientia Clinical Research
  Randwick, Australia Recruiting
• UZ Antwerpen
  Edegem, Belgium Recruiting
• Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
  Liège, Belgium Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.