Actively Recruiting
A Phase 1, First-in-Human Study of a Novel CD79bxCD20xCD3 Trispecific Antibody in B-Cell Non-Hodgkin Lymphoid Malignancies
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
130
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, dosing, and clinical activity of a new drug called JNJ-95566692, alone and in combination with another drug, JNJ-87801493, in adults with B-cell non-Hodgkin lymphoid malignancies who have relapsed or refractory disease. This Phase 1 study aims to find the best doses and schedules for these treatments and to further understand their effects. Participants in the first part of the study will receive increasing doses of JNJ-95566692 alone or with JNJ-87801493 to identify the recommended doses and schedules. In the second part, participants will receive these drugs at the recommended doses to assess safety, how the drugs behave in the body, and their clinical activity. Both drugs are given by injection under the skin. Throughout the study, participants will be monitored for side effects, drug levels in the blood, immune responses, and how their disease responds to treatment. Researchers will measure adverse events, dose-limiting toxicities, overall response, complete response, time to response, duration of response, and progression-free survival over about two years and eight months. Participants will have regular assessments to track these outcomes and safety.
CONDITIONS
Brief Title
A Study of JNJ-95566692 in Participants With Non-Hodgkin Lymphoid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Diagnosed with B-cell non-Hodgkin lymphoid malignancies (NHL) with relapsed or refractory disease
- Have received at least 2 prior lines of therapy including an alpha CD20 monoclonal antibody chemotherapy combination
- Participants who have received at least one prior therapy but lack access or eligibility for standard second line therapies may enroll
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Measurable disease according to Lugano criteria
- Negative pregnancy test for participants of childbearing potential and agreement to further testing
- Must not breastfeed, become pregnant, or donate gametes while on treatment and for 3 months after last dose
- Must agree to use external condoms during the same period
You will not qualify if you...
- Known active central nervous system (CNS) or leptomeningeal involvement
- Prior solid-organ transplantation
- Any malignancy other than NHL diagnosed within 1 year prior to study treatment, except certain skin and cervical cancers or cancers considered cured
- Autoimmune or inflammatory disease requiring systemic steroids or immunosuppressive agents within 3 months prior to study treatment
- Toxicity from prior anticancer therapy not resolved to baseline or Grade 1 or less (except certain stable conditions)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years and 8 months
Participants receive escalating doses of JNJ-95566692 alone or in combination with JNJ-87801493 administered subcutaneously to determine the recommended dose and assess safety and clinical activity.
Visits occur regularly during dosing for safety and pharmacokinetic assessments
Trial Site Locations
Total: 9 locations
1
Monash Medical Centre
Clayton, Australia, 3168
Actively Recruiting
2
Peter MacCallum Cancer Centre
Melbourne, Australia, 3000
Actively Recruiting
3
Macquarie University Hospital
North Ryde, Australia, 2109
Actively Recruiting
4
Scientia Clinical Research
Randwick, Australia, 2031
Actively Recruiting
5
UZ Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
6
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liège, Belgium, 4000
Actively Recruiting
7
SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi
Ankara, Turkey (Türkiye), 06200
Actively Recruiting
8
Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi
Ankara, Turkey (Türkiye), 06620
Actively Recruiting
9
Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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