JNJ-95566692 alone or with JNJ-87801493 for relapsed or refractory B‑cell non‑Hodgkin lymphoma
A Phase 1, First-in-Human Study of a Novel CD79bxCD20xCD3 Trispecific Antibody in B-Cell Non-Hodgkin Lymphoid Malignancies (NHLs)
This trial tests whether the drug JNJ-95566692, given alone or with JNJ-87801493, helps people with relapsed or refractory B‑cell non‑Hodgkin lymphoma who have had prior therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | CAR-T, chemotherapy, methotrexate |
| Locations | 8 sites (Melbourne and 7 other locations) |
| Trial ID | NCT07308132 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with relapsed or refractory B‑cell non‑Hodgkin lymphoma per WHO 2022 who have measurable disease, ECOG 0–1, and have received at least two prior lines of therapy including an anti‑CD20 chemotherapy regimen (or who lack access to standard second‑line therapies) are the intended candidates.
Not a fit: Patients with non–B‑cell lymphomas, earlier‑stage disease, poor performance status (ECOG ≥2), pregnancy or breastfeeding, or those with effective approved therapies available are unlikely to benefit from this Phase 1 trial.
Why it matters
Potential benefit: If successful, these drugs could provide a new treatment option that produces tumor responses for people with relapsed or refractory B‑cell non‑Hodgkin lymphoma.
How similar studies have performed: Other targeted and combination approaches in relapsed B‑cell NHL have produced meaningful responses, but JNJ‑95566692 is investigational and has limited published clinical data to date.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * B-cell non-Hodgkin lymphoid malignancies (NHL) according to World Health Organization (WHO) 2022 with relapsed or refractory disease and no other approved therapies available that would be more appropriate in the investigator's judgment. • Participants must have received at least 2 prior lines of therapy including an αCD20 monoclonal antibody containing chemotherapy combination schedule. • Participants who have received at least one prior line of therapy but are not eligible or do not have access to standard second line therapies, such as CAR-T, will be allowed to enroll * 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 * 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) * 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 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 this trial is running
Melbourne and 7 other locations
- 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)
- 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)
- Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.