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)
Part 1 and 2: Number of Participants with Adverse Events (AEs) And Serious Adverse Events (SAEs) by Severity — Approximately 2 years and 8 months An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity for AEs will be specified as per: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grades which are Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (potentially life-threatening) and Grade 5 (death related to adverse event). SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Part 1: Number of Participants with Dose Limiting Toxicity (DLTs) — Approximately 2 years and 8 months Number of participants with DLTs for JNJ-95566692 (arm A), in combination with JNJ-87801493 (arm B) and in arms C to G will be reported. The DLTs are drug-related toxicities and are defined as any of the following: fatal toxicity, high grade non-hematologic toxicity, or hematologic toxicity.
Trial sites (19)
Facility
City
Region
Status
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
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.
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