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

NCT07308132
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
340
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Lead sponsor
Janssen Research & Development, LLC
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Start date
2026-01-20
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Number of sites
19
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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) and for JNJ-95566692 with or without JNJ-87801493 with various standard of care (SOC) regimens (Arms C-G) in Part 1: Dose Escalation part of the study. Part 2: Dose Expansion part of the study will further characterize the safety.
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Short title
A Study of JNJ-95566692 in Participants With Non-Hodgkin Lymphoid Malignancies
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Official title
A Phase 1, First-in-Human Study of a Novel CD79bxCD20xCD3 Trispecific Antibody in B-Cell Non-Hodgkin Lymphoid Malignancies (NHLs)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2029-10-31
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First posted
2025-12-29
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Registry last updated
2026-09-10
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Primary completion date
2028-08-31
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Start date
2026-01-20
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Participants
340
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Participant count basis
Estimated
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Planned participants
340
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Protocol amendments
3
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Number of sites
19
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Janssen Research & Development, LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07308132
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ClinicalTrials.gov ID
NCT07308132
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Part 1 and 2: Number of Participants with Adverse Events (AEs) And Serious Adverse Events (SAEs) by Severity

    Timeframe: 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)

    Timeframe: Approximately 2 years and 8 months

    Number of participants with DLTs for JNJ-95566692 (arm A), in combination with JNJ-87801493 (arm B) and in arms C to G 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.

  1. Serum Concentration for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

    Timeframe: Approximately 2 years and 8 months

    Serum concentration for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be assessed using a validated assay method.

  2. Area Under the Curve During a Dosing Interval (AUCtau) in JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

    Timeframe: 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 (Arms A-G) And JNJ-87801493 (Arms B-G)

    Timeframe: Approximately 2 years and 8 months

    Cmax for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

  4. Minimum Serum Concentration (Cmin) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

    Timeframe: Approximately 2 years and 8 months

    Cmin for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

  5. Area Under the Curve (AUC[0-t]) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

    Timeframe: Approximately 2 years and 8 months

    AUC(0-t) for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

  6. Half-life (t1/2) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

    Timeframe: Approximately 2 years and 8 months

    Half-life (t1/2) for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

  7. Time to Reach Cmax (Tmax) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

    Timeframe: Approximately 2 years and 8 months

    Tmax is the time to reach maximum observed serum concentration for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

  8. Apparent Total Body Clearance (CL/F) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

    Timeframe: Approximately 2 years and 8 months

    CL/F for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

  9. Apparent Volume of Distribution (V/F) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

    Timeframe: Approximately 2 years and 8 months

    V/F for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

  10. Number of Participants with Anti-JNJ-95566692 Antibodies in Arms A to G

    Timeframe: Approximately 2 years and 8 months

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

  11. Number of Participants with Anti-JNJ-87801493 Antibodies in Arms B to G

    Timeframe: Approximately 2 years and 8 months

    Participants with presence of antibodies binding to JNJ-87801493 in arm B to G (as appropriate) will be reported.

  12. Part 2: Overall Response for JNJ-95566692 (Arm A), in Combination With JNJ-87801493 (Arm B) And for JNJ-95566692 ± JNJ-87801493 with Combination Therapies In Arms C to G

    Timeframe: 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), in Combination With JNJ-87801493 (Arm B) And for JNJ-95566692 ± JNJ-87801493 with Combination Therapies In Arms C to G

    Timeframe: 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), in Combination With JNJ-87801493 (Arm B) And for JNJ-95566692 ± JNJ-87801493 with Combination Therapies In Arms C to G

    Timeframe: 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), in Combination With JNJ-87801493 (Arm B) And for JNJ-95566692 ± JNJ-87801493 with Combination Therapies In Arms C to G

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • B-cell non-Hodgkin lymphoid malignancies (NHL) according to World Health Organization (WHO) 2022 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: -diffuse large B-cell lymphoma not otherwise specified (NOS), -T-cell/histiocyte-rich large B-cell lymphoma, -diffuse large B-cell lymphoma/high grade B-cell lymphoma with MYC and BCL2 rearrangements, -large B-cell lymphoma with IRF4 rearrangement, -high grade B-cell lymphoma with 11q aberrations, -Epstein-Barr virus (EBV)-positive diffuse large B-cell lymphoma, -diffuse large B-cell lymphoma associated with chronic inflammation, -primary large B-cell lymphoma of immune privileged sites, -primary cutaneous diffuse large B-cell lymphoma-leg type , -primary mediastinal large B-cell lymphoma, -high-grade B-cell lymphoma NOS, -transformations of indolent B-cell lymphoma (For US sites). -Other B-cell NHL may be enrolled based on emerging data in specific cohorts as stipulated by study evaluation team (SET)
  • 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)
  • 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; -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, -For Arm E ONLY: Practice 2 methods of reliable birth control simultaneously, including 1 highly effective form of contraception and 1 additional effective contraceptive method., -Participants on Arms C-G should also follow the pregnancy and contraception restrictions in the respective local corresponding product label

  • 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)
Sources for eligibility
clinicaltrials.gov

  • Monash Medical CentreClayton, AustraliaRecruiting
  • Peter MacCallum Cancer CentreMelbourne, AustraliaRecruiting
  • Macquarie University HospitalNorth Ryde, AustraliaRecruiting
  • Scientia Clinical ResearchRandwick, AustraliaRecruiting
  • UZ AntwerpenEdegem, BelgiumRecruiting
  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart TilmanLiège, BelgiumRecruiting
  • Hopital Claude HuriezLille, FranceRecruiting
  • CHU Pitie SalpetriereParis, FranceRecruiting
  • CHU Lyon SudPierre-Bénite, FranceRecruiting
  • Institut Universitaire du Cancer Toulouse OncopoleToulouse, FranceRecruiting
  • Hosp Univ Vall D HebronBarcelona, SpainRecruiting
  • Hosp. Clinic de BarcelonaBarcelona, SpainRecruiting
  • Hosp Univ Fund Jimenez DiazMadrid, SpainRecruiting
  • Hosp. Univ. 12 de OctubreMadrid, SpainRecruiting
  • Hosp Univ Hm SanchinarroMadrid, SpainRecruiting
  • Ankara, Turkey (Türkiye)Recruiting
  • Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma MerkeziAnkara, Turkey (Türkiye)Recruiting
  • Memorial Antalya Hastanesi Faz 1 Klinik Arastirma MerkeziAntalya, Turkey (Türkiye)Recruiting
  • Koc Universitesi Hastanesi Faz 1 Klinik Arastirma MerkeziIstanbul, Turkey (Türkiye)Recruiting
Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-523297-16-00
  • 95566692LYM1001
Sources for references
clinicaltrials.gov

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