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RECRUITING Phase 1 ClinicalTrials.gov

A Study of JNJ-95566692 in Participants With Non-Hodgkin Lymphoid Malignancies

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT07308132

Registry updated: 2026-09-10
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Description

The purpose of this study is to determine the putative recommended Phase 2 doses (RP2Ds) and optimal dose schedule(s) for JNJ-95566692 as a single agent (Arm A) and in combination with JNJ-87801493 (Arm B) and for JNJ-95566692 with or without JNJ-87801493 with various standard of care (SOC) regimens (Arms C-G) in Part 1: Dose Escalation part of the study. Part 2: Dose Expansion part of the study will further characterize the safety.

Interventions

  • JNJ-95566692 (Drug)
    JNJ-95566692 will be administered subcutaneously.
  • JNJ-87801493 (Drug)
    JNJ-87801493 will be administered subcutaneously.
  • loncastuximab tesirine (Drug)
    Loncastuximab tesirine will be administered intervenously.
  • Lenalidomide (Drug)
    Lenalidomide will be administered orally.
  • Rituximab (Drug)
    Rituximab will be administered intravenously and may be administered subcutaneously after the first administration.
  • Gemcitabine (Drug)
    Gemcitabine will be administered intravenously.
  • Oxaliplatin (Drug)
    Oxaliplatin will be administered intravenously.
  • Cyclophosphamide (Drug)
    Cyclophosphamide will be administered intravenously.
  • Doxorubicin (Drug)
    Doxorubicin will be administered intravenously.
  • Vincristine (Drug)
    Vincristine will be administered intravenously.
  • Prednisone (Drug)
    Prednisone will be administered orally.
  • Polatuzumab vedotin (Drug)
    Polatuzumab vedotin will be administered intravenously.

Eligibility criteria

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)

Conditions

Lymphoma, Non-Hodgkin

Locations

  • Monash Medical Centre — Clayton, Australia
  • Peter MacCallum Cancer Centre — Melbourne, Australia
  • Macquarie University Hospital — North Ryde, Australia
  • Scientia Clinical Research — Randwick, Australia
  • UZ Antwerpen — Edegem, Belgium
  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman — Liège, Belgium
  • Hopital Claude Huriez — Lille, France
  • CHU Pitie Salpetriere — Paris, France
  • CHU Lyon Sud — Pierre-Bénite, France
  • Institut Universitaire du Cancer Toulouse Oncopole — Toulouse, France
  • Hosp Univ Vall D Hebron — Barcelona, Spain
  • Hosp. Clinic de Barcelona — Barcelona, Spain
  • Hosp Univ Fund Jimenez Diaz — Madrid, Spain
  • Hosp. Univ. 12 de Octubre — Madrid, Spain
  • Hosp Univ Hm Sanchinarro — Madrid, Spain
  • SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi — Ankara, Turkey (Türkiye)
  • Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi — Ankara, Turkey (Türkiye)
  • Memorial Antalya Hastanesi Faz 1 Klinik Arastirma Merkezi — Antalya, Turkey (Türkiye)
  • Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi — Istanbul, Turkey (Türkiye)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record