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

NCT07308132 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 95566692LYM10012025-523297-16-00
• Study Type: interventional
• Target: 130
• Locations: 3 countries
• Sites: 8

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 as a single agent (Arm A) and in combination with JNJ-87801493 (Arm B) (Part 1: Dose Escalation) and to further characterize the safety and clinical activity of JNJ-95566692 as a single agent (Arm A) and in combination with JNJ-87801493 (Arm B) at the putative RP2D(s) (Part 2: Dose Expansion).

Conditions

Lymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (2)

• Part 1 and 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B)

  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.

  Approximately 2 years and 8 months

• Part 1: Number of Participants with Dose Limiting Toxicity (DLTs) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B)

  Number of participants with DLTs for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) 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.

  Approximately 2 years and 8 months

Secondary Outcomes (16)

• Serum Concentration for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B)

  Approximately 2 years and 8 months

• Area Under the Curve During a Dosing Interval (AUCtau) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B)

  Approximately 2 years and 8 months

• Maximum Serum Concentration (Cmax) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B)

  Approximately 2 years and 8 months

• Minimum Serum Concentration (Cmin) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B)

  Approximately 2 years and 8 months

• Area Under the Curve (AUC[0-t]) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B)

  Approximately 2 years and 8 months

Study Arms (2)

Arm A: JNJ-95566692

EXPERIMENTAL

Participants will receive escalating doses of JNJ-95566692 in Part 1 (Dose escalation) to determine the putative recommended Phase 2 doses (RP2D\[s\]) and 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), pharmacodynamic (PD) and clinical activity.

Drug: JNJ-95566692

Arm B: JNJ-95566692 in combination with JNJ-87801493

EXPERIMENTAL

Participants will receive escalating doses of JNJ-95566692 in combination with JNJ-87801493 in Part 1 (Dose escalation) to determine the putative RP2D\[s\] and dosing schedule(s). Participants in Part 2 (Dose expansion) will receive JNJ-95566692 in combination with JNJ-87801493 at the putative RP2D(s) determined in Part 1 to further characterize safety, PK, PD and clinical activity.

Drug: JNJ-95566692; Drug: JNJ-87801493

Interventions

JNJ-87801493 DRUG

JNJ-87801493 will be administered subcutaneously.

Arm B: JNJ-95566692 in combination with JNJ-87801493

JNJ-95566692 DRUG

JNJ-95566692 will be administered subcutaneously.

Arm A: JNJ-95566692; Arm B: JNJ-95566692 in combination with JNJ-87801493

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (8)

Peter MacCallum Cancer Centre

Melbourne, 3000, Australia

RECRUITING

Macquarie University Hospital

North Ryde, 2109, Australia

RECRUITING

Scientia Clinical Research

Randwick, 2031, Australia

RECRUITING

UZ Antwerpen

Edegem, 2650, Belgium

RECRUITING

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

Liège, 4000, Belgium

RECRUITING

SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi

Ankara, 06200, Turkey (Türkiye)

RECRUITING

Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi

Ankara, 06620, Turkey (Türkiye)

RECRUITING

Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

TU (3); AU (3); BE (2)