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Clinical Trials in Australia / NCT07308132
Recruiting Phase 1

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

NCT07308132 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1
Started
2026-01-20
Last updated
2026-09-10

Condition(s) studied

Lymphoma, Non-Hodgkin

Investigational drug(s) / intervention(s)

JNJ-95566692JNJ-87801493 →loncastuximab tesirine →Lenalidomide →Rituximab →Gemcitabine →Oxaliplatin →Cyclophosphamide →Doxorubicin →Vincristine →Prednisone →Polatuzumab vedotin →

JNJ-95566692: JNJ-95566692 will be administered subcutaneously.

JNJ-87801493: JNJ-87801493 will be administered subcutaneously.

loncastuximab tesirine: Loncastuximab tesirine will be administered intervenously.

Lenalidomide: Lenalidomide will be administered orally.

Rituximab: Rituximab will be administered intravenously and may be administered subcutaneously after the first administration.

Gemcitabine: Gemcitabine will be administered intravenously.

Oxaliplatin: Oxaliplatin will be administered intravenously.

Cyclophosphamide: Cyclophosphamide will be administered intravenously.

Doxorubicin: Doxorubicin will be administered intravenously.

Vincristine: Vincristine will be administered intravenously.

Prednisone: Prednisone will be administered orally.

Polatuzumab vedotin: Polatuzumab vedotin will be administered intravenously.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
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
Hopital Claude Huriez Lille France Recruiting
CHU Pitie Salpetriere Paris France Recruiting
CHU Lyon Sud Pierre-Bénite France Recruiting
Institut Universitaire du Cancer Toulouse Oncopole Toulouse France Recruiting
Hosp Univ Vall D Hebron Barcelona Spain Recruiting
Hosp. Clinic de Barcelona Barcelona Spain Recruiting
Hosp Univ Fund Jimenez Diaz Madrid Spain Recruiting
Hosp. Univ. 12 de Octubre Madrid Spain Recruiting
Hosp Univ Hm Sanchinarro Madrid Spain Recruiting
SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi Ankara Turkey (Türkiye) Recruiting
Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi Ankara Turkey (Türkiye) Recruiting
Memorial Antalya Hastanesi Faz 1 Klinik Arastirma Merkezi Antalya Turkey (Türkiye) Recruiting
Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi Istanbul Turkey (Türkiye) Recruiting

On this site

📄 Revlimid (lenalidomide) drug profile → 📄 Rituxan (rituximab) drug profile → 📄 Deltasone (prednisone) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07308132 on ClinicalTrials.gov ↗ ← All trials in Australia