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

NCT ID: NCT07308132

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-16
• Study Completion Date: 2028-08-31

Brief Summary

The purpose of this study is to determine the putative recommended Phase 2 doses (RP2Ds) and optimal dose schedule(s) for JNJ-95566692 (Part 1: Dose Escalation) and to further characterize the safety and clinical activity of JNJ-95566692 at the putative RP2D(s) (Part 2: Dose Expansion).

Conditions

Lymphoma, Non-Hodgkin

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JNJ-95566692

Participants will receive escalating doses of JNJ-95566692 in Part 1 (Dose escalation) to determine the putative recommended Phase 2 doses (RP2D\[s\]) and optimal dosing schedule(s). Participants in Part 2 (Dose expansion) will receive JNJ-95566692 at the putative RP2D(s) determined in Part 1 to further characterize safety, PK (pharmacokinetic), PD and clinical activity.

Group Type: EXPERIMENTAL

JNJ-95566692

Intervention Type: DRUG

JNJ-95566692 will be administered subcutaneously.

Interventions

JNJ-95566692

JNJ-95566692 will be administered subcutaneously.

Intervention Type: DRUG

Eligibility 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 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Central Contacts

Study Contact

Role: CONTACT

Phone: 844-434-4210

Email: Participate-In-This-Study1@its.jnj.com

Other Identifiers

95566692LYM1001

Identifier Type: OTHER

Identifier Source: secondary_id

2025-523297-16-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

95566692LYM1001

Identifier Type: -

Identifier Source: org_study_id