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Recruiting Phase 1

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

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About this study

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.

Condition
Lymphoma, Non-Hodgkin
Tested
JNJ-95566692, JNJ-87801493, loncastuximab tesirine, Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin, Cyclophosphamide,...
Sponsor
Janssen Research & Development, LLC

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 6

  • Minimum age: 18 years
  • Study condition: Lymphoma, Non-Hodgkin
  • 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
  • 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 5

  • 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

19 sites, 19 recruiting

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

and 13 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.