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NCT Number: NCT07308132

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Monash Medical Centre, Clayton, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. • Histologic documentation of the following large B-cell lymphomas: o diffuse large B-cell lymphoma not otherwise specified (NOS), T-cell/histiocyte-rich large B-cell lymphoma, o diffuse large B-cell lymphoma/high grade B-cell lymphoma with MYC and BCL2 rearrangements, o large B-cell lymphoma with IRF4 rearrangement, o high grade B-cell lymphoma with 11q aberrations, o Epstein-Barr virus (EBV)-positive diffuse large B-cell lymphoma, o diffuse large B-cell lymphoma associated with chronic inflammation, o primary large B-cell lymphoma of immune privileged sites, o primary cutaneous diffuse large B-cell lymphoma-leg type , o primary mediastinal large B-cell lymphoma, o high-grade B-cell lymphoma NOS, o transformations of indolent B-cell lymphoma (For US sites). • 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 chimeric antigen receptor (CAR)-T, will be allowed to enroll. • Other B-cell NHL may be enrolled based on emerging data in specific cohorts as stipulated by study evaluation team (SET)
  • 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)

Treatment and study plan

JNJ-95566692

Drug

JNJ-95566692 will be administered subcutaneously.

JNJ-87801493

Drug

JNJ-87801493 will be administered subcutaneously.

Primary outcomes

  1. 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)

    Time frame: Approximately 2 years and 8 months

    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.

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

    Time frame: Approximately 2 years and 8 months

    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.

Secondary outcomes

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

    Time frame: Approximately 2 years and 8 months

    Serum concentration for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be assessed using a validated assay method.

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

    Time frame: Approximately 2 years and 8 months

    AUC tau is defined as area under the serum concentration-time curve during a dosing interval (tau).

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

    Time frame: Approximately 2 years and 8 months

    Cmax for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported.

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

    Time frame: Approximately 2 years and 8 months

    Cmin for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported.

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

    Time frame: Approximately 2 years and 8 months

    AUC(0-t) for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported.

  6. Half-life (t1/2) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B)

    Time frame: Approximately 2 years and 8 months

    Half-life (t1/2) for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported.

  7. Time to Reach Cmax (Tmax) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B)

    Time frame: Approximately 2 years and 8 months

    Tmax is the time to reach maximum observed serum concentration for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B).

  8. Apparent Total Body Clearance (CL/F) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B)

    Time frame: Approximately 2 years and 8 months

    CL/F for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported.

  9. Apparent Volume of Distribution (V/F) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B)

    Time frame: Approximately 2 years and 8 months

    V/F for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported.

  10. Number of Participants with Anti-JNJ-95566692 Antibodies in Arm A and Arm B

    Time frame: Approximately 2 years and 8 months

    Participants with presence of antibodies binding to JNJ-95566692 in arm A and arm B will be reported.

  11. Number of Participants with Anti-JNJ-87801493 Antibodies in Arm B

    Time frame: Approximately 2 years and 8 months

    Participants with presence of antibodies binding to JNJ-87801493 in arm B will be reported.

  12. Part 2: Overall Response for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B)

    Time frame: Approximately 2 years and 8 months

    Overall response is defined as a best response of partial response (PR) or better as assessed by the investigator according to standard response criteria per Lugano.

  13. Part 2: Complete Response (CR) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B)

    Time frame: Approximately 2 years and 8 months

    Complete response (CR) is defined as a best response of CR as assessed by the investigator according to standard response criteria per Lugano.

  14. Part 2: Time to Response (TTR) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B)

    Time frame: Approximately 2 years and 8 months

    TTR is defined for participants who achieved a response of PR or better as the time from the first dose of study treatment to the first response of PR or better.

  15. Part 2: Duration of Response (DOR) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B)

    Time frame: Approximately 2 years and 8 months

    DOR is defined for participants who achieved a response of PR or better as the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease, initiation of a new systemic anti-cancer therapy or death.

  16. Part 2: Progression-free survival (PFS) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B)

    Time frame: Approximately 2 years and 8 months

    PFS is defined as the time from the date of first dose of study treatment to the date of first documented evidence of progressive disease (as defined in the disease-specific response criteria; unless) or death due to any cause, whichever occurs first.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 1, First-in-Human Study of a Novel CD79bxCD20xCD3 Trispecific Antibody in B-Cell Non-Hodgkin Lymphoid Malignancies (NHLs)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 29, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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