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En undersøgelse af JNJ-95566692 hos deltagere med non-Hodgkin lymfoid maligniteter

4. september 2026 opdateret af: Janssen Research & Development, LLC

En fase 1, første-på-mennesker-studie af et nyt CD79bxCD20xCD3 trispecifikt antistof i B-celle non-Hodgkin lymfoide maligniteter (NHL)

Formålet med denne undersøgelse er at fastlægge de formodede anbefalede fase 2-doser (RP2D'er) og den optimale dosisplan (eller -planer) for JNJ-95566692 (del 1: dosisstigning) og yderligere at karakterisere sikkerheden og den kliniske aktivitet af JNJ-95566692 ved den formodede RP2D (eller -RP2D'er) (del 2: dosisudvidelse).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

340

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Australien
      • Clayton, Australien, 3168
        • Rekruttering
        • Monash Medical Centre
      • Melbourne, Australien, 3000
        • Rekruttering
        • Peter MacCallum Cancer Centre
      • North Ryde, Australien, 2109
        • Rekruttering
        • Macquarie University Hospital
      • Randwick, Australien, 2031
        • Rekruttering
        • Scientia Clinical Research
  • Belgien
      • Edegem, Belgien, 2650
        • Rekruttering
        • UZ Antwerpen
      • Liège, Belgien, 4000
        • Rekruttering
        • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
  • Frankrig
      • Lille, Frankrig, 59000
        • Rekruttering
        • Hôpital Claude Huriez
      • Paris, Frankrig, 75013
        • Rekruttering
        • CHU Pitie Salpetriere
      • Pierre-Bénite, Frankrig, 69495
        • Rekruttering
        • CHU Lyon Sud
      • Toulouse, Frankrig, 31100
        • Rekruttering
        • Institut Universitaire du Cancer Toulouse Oncopole
  • Spanien
      • Barcelona, Spanien, 8036
        • Rekruttering
        • Hosp. Clinic de Barcelona
      • Barcelona, Spanien, 08035
        • Rekruttering
        • Hosp Univ Vall D Hebron
      • Madrid, Spanien, 28041
        • Rekruttering
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spanien, 28040
        • Rekruttering
        • Hosp Univ Fund Jimenez Diaz
      • Madrid, Spanien, 28050
        • Rekruttering
        • Hosp Univ Hm Sanchinarro
  • Tyrkiet (Türkiye)
      • Ankara, Tyrkiet (Türkiye), 06200
        • Rekruttering
        • SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi
      • Ankara, Tyrkiet (Türkiye), 06620
        • Rekruttering
        • Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi
      • Antalya, Tyrkiet (Türkiye), 07025
        • Rekruttering
        • Memorial Antalya Hastanesi Faz 1 Klinik Arastirma Merkezi
      • Istanbul, Tyrkiet (Türkiye), 34010
        • Rekruttering
        • Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • B-celle non-Hodgkin lymfoid maligne sygdomme (NHL) i henhold til World Health Organization (WHO) 2022 med tilbagevendende eller refraktær sygdom og ingen andre godkendte terapier tilgængelige, der ville være mere passende efter forskerens bedømmelse.
    • Deltagere skal have modtaget mindst 2 tidligere behandlingslinjer, inklusive en αCD20 monoklonal antistof indeholdende kemoterapikombinationsplan.
    • Deltagere, der har modtaget mindst én tidligere behandlingslinje, men som ikke er berettigede til eller har adgang til standard andenlinjestandarderapier, såsom CAR-T, vil få lov til at deltage
  • Mens de er under studibehandling og i 3 måneder efter den sidste dosis af studibehandling, skal en deltager: ikke amme eller blive gravid; ikke donere gameter (dvs. æg eller sæd) eller fryse til fremtidig brug til formål for assisteret reproduktion; og bære et eksternt kondom
  • Have en Eastern Cooperative Oncology Group (ECOG) performance status på 0 til 1
  • Deltagere skal have målelig sygdom som defineret af sygdomskriterierne (Lugano-kriterier)
  • Deltagere med fødedygtighed skal have en negativ højt følsom (for eksempel beta [β]-human chorionic gonadotropin) graviditetstest ved screening og inden for 24 timer før første dosis af studibehandling og acceptere yderligere graviditetstest

Eksklusionskriterier:

  • Kendt centralnervesystem involvering (CNS) eller leptomeningeal involvering
  • Tidligere transplantation af fast organ
  • Diagnose af malignitet andet end den undersøgte sygdom inden for 1 år før første dosis af studibehandlingen; undtagelser er pladecelle- og basalcellecarcinom i huden, carcinoma in situ i livmoderhalsen og enhver malignitet, der anses for helbredt eller har minimal risiko for tilbagefald inden for 1 år efter første dosis af studibehandlingen efter både forskerens og sponsorernes medicinske monitors vurdering
  • Autoimmun eller inflammatorisk sygdom, der kræver systemiske steroider eller andre immunsuppressive midler (for eksempel methotrexat eller tacrolimus) inden for 3 måneder før første dosis af studibehandling
  • Toksicitet fra tidligere antikræftbehandling, der ikke er vendt tilbage til basisniveau eller til grad mindre end eller lig med (<=) 1 (undtagen hårtab, vitiligo, perifer neuropati eller endokrinopatier af grad <=2, der er stabile på hormonerstatning)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm A: JNJ-95566692
Deltagerne vil modtage stigende doser af JNJ-95566692 i del 1 (dosiseskalering) for at bestemme den formodede anbefalede fase 2-dosis (RP2D[s]) og doseringsskema(er). Deltagerne i del 2 (dosisudvidelse) vil modtage JNJ-95566692 med den formodede RP2D(s), der blev bestemt i del 1, for yderligere at karakterisere sikkerhed, PK (farmakokinetik), farmakodynamik (PD) og klinisk aktivitet.
Medicin: JNJ-95566692
JNJ-95566692 administreres subkutant.
Eksperimentel: Arm B: JNJ-95566692 i kombination med JNJ-87801493
Deltagerne vil modtage stigende doser af JNJ-95566692 i kombination med JNJ-87801493 i del 1 (dosisopskalering) for at bestemme den formodede RP2D[s] og doseringsskema(er). Deltagerne i del 2 (dosisudvidelse) vil modtage JNJ-95566692 i kombination med JNJ-87801493 ved den formodede RP2D(s), der blev bestemt i del 1, for yderligere at karakterisere sikkerhed, PK, PD og klinisk aktivitet.
Medicin: JNJ-87801493
JNJ-87801493 vil blive administreret subkutant.
Medicin: JNJ-95566692
JNJ-95566692 administreres subkutant.
Eksperimentel: Arm C: JNJ-95566692 and loncastuximab tesirine with or without JNJ-87801493
Participants will receive escalating doses for JNJ-95566692 and loncastuximab tesirine with or without JNJ-87801493 followed by the target dose 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 and loncastuximab tesirine with or without JNJ-87801493 at the putative RP2D(s) determined in Part 1.
Medicin: JNJ-87801493
JNJ-87801493 vil blive administreret subkutant.
Medicin: JNJ-95566692
JNJ-95566692 administreres subkutant.
Medicin: loncastuximab tesirine
Loncastuximab tesirine will be administered intervenously.
Eksperimentel: Arm D: JNJ-95566692 and R-GemOx with or without JNJ-87801493
Participants will receive escalating doses of JNJ-95566692 and R-GemOx (rituximab, gemcitabine, oxaliplatin) with or without JNJ-87801493 followed by the target dose 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 and R-GemOx with or without JNJ-87801493 at the putative RP2D(s) determined in Part 1.
Medicin: JNJ-87801493
JNJ-87801493 vil blive administreret subkutant.
Medicin: JNJ-95566692
JNJ-95566692 administreres subkutant.
Medicin: Rituximab
Rituximab will be administered intravenously and may be administered subcutaneously after the first administration.
Medicin: Gemcitabine
Gemcitabine will be administered intravenously.
Medicin: Oxaliplatin
Oxaliplatin will be administered intravenously.
Eksperimentel: Arm E: JNJ-95566692 and lenalidomide with or without JNJ-87801493
Participants will receive escalating doses of JNJ-95566692 and lenalidomide with or without 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 and lenalidomide with or without JNJ-87801493 at the putative RP2D(s) determined in Part 1.
Medicin: Lenalidomid
Lenalidomid vil blive indgivet oralt.
Medicin: JNJ-87801493
JNJ-87801493 vil blive administreret subkutant.
Medicin: JNJ-95566692
JNJ-95566692 administreres subkutant.
Eksperimentel: Arm F: JNJ-95566692 and R-CHOP with or without JNJ-87801493
Participants will receive escalating doses of JNJ-95566692 and R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) with or without JNJ-87801493 followed by the target dose 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 and R-CHOP with or without JNJ-87801493 at the putative RP2D(s) determined in Part 1.
Medicin: Cyclofosfamid
Cyclophosphamid vil blive administreret intravenøst.
Medicin: Prednison
Prednison vil blive indgivet oralt.
Medicin: JNJ-87801493
JNJ-87801493 vil blive administreret subkutant.
Medicin: JNJ-95566692
JNJ-95566692 administreres subkutant.
Medicin: Rituximab
Rituximab will be administered intravenously and may be administered subcutaneously after the first administration.
Medicin: Doxorubicin
Doxorubicin will be administered intravenously.
Medicin: Vincristine
Vincristine will be administered intravenously.
Eksperimentel: Arm G: JNJ-95566692 and Pola-R-CHP with or without JNJ-87801493
Participants will receive escalating doses of JNJ-95566692 and Pola-R-CHP (polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone) with or without JNJ-87801493 followed by the target dose 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 and Pola-R-CHP with or without JNJ-87801493 at the putative RP2D(s) determined in Part 1.
Medicin: Cyclofosfamid
Cyclophosphamid vil blive administreret intravenøst.
Medicin: Prednison
Prednison vil blive indgivet oralt.
Medicin: JNJ-87801493
JNJ-87801493 vil blive administreret subkutant.
Medicin: JNJ-95566692
JNJ-95566692 administreres subkutant.
Medicin: Rituximab
Rituximab will be administered intravenously and may be administered subcutaneously after the first administration.
Medicin: Doxorubicin
Doxorubicin will be administered intravenously.
Medicin: Polatuzumab vedotin
Polatuzumab vedotin will be administered intravenously.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part 1 and 2: Number of Participants with Adverse Events (AEs) And Serious Adverse Events (SAEs) by Severity
Tidsramme: 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.
Approximately 2 years and 8 months
Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)
Tidsramme: 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.
Approximately 2 years and 8 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum Concentration for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)
Tidsramme: 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.
Approximately 2 years and 8 months
Area Under the Curve During a Dosing Interval (AUCtau) in JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)
Tidsramme: Approximately 2 years and 8 months
AUC tau is defined as area under the serum concentration-time curve during a dosing interval (tau).
Approximately 2 years and 8 months
Maximum Serum Concentration (Cmax) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)
Tidsramme: Approximately 2 years and 8 months
Cmax for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.
Approximately 2 years and 8 months
Minimum Serum Concentration (Cmin) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)
Tidsramme: Approximately 2 years and 8 months
Cmin for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.
Approximately 2 years and 8 months
Area Under the Curve (AUC[0-t]) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)
Tidsramme: 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.
Approximately 2 years and 8 months
Half-life (t1/2) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)
Tidsramme: 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.
Approximately 2 years and 8 months
Time to Reach Cmax (Tmax) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)
Tidsramme: 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.
Approximately 2 years and 8 months
Apparent Total Body Clearance (CL/F) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)
Tidsramme: 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.
Approximately 2 years and 8 months
Apparent Volume of Distribution (V/F) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)
Tidsramme: 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.
Approximately 2 years and 8 months
Number of Participants with Anti-JNJ-95566692 Antibodies in Arms A to G
Tidsramme: Approximately 2 years and 8 months
Participants with presence of antibodies binding to JNJ-95566692 in arm A to G will be reported.
Approximately 2 years and 8 months
Number of Participants with Anti-JNJ-87801493 Antibodies in Arms B to G
Tidsramme: 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.
Approximately 2 years and 8 months
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
Tidsramme: 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.
Approximately 2 years and 8 months
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
Tidsramme: 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.
Approximately 2 years and 8 months
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
Tidsramme: 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.
Approximately 2 years and 8 months
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
Tidsramme: 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.
Approximately 2 years and 8 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen Research & Development, LLC

Efterforskere

  • Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. januar 2026

Primær færdiggørelse (Anslået)

31. august 2028

Studieafslutning (Anslået)

31. oktober 2029

Datoer for studieregistrering

Først indsendt

15. december 2025

Først indsendt, der opfyldte QC-kriterier

15. december 2025

Først opslået (Faktiske)

29. december 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 95566692LYM1001 (Anden identifikator: Janssen Research & Development, LLC)
  • 2025 (U.S. NIH-bevilling/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523297-16-00 (Registry Identifier: EUCT number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Johnson & Johnson Innovative Medicines politik for datadeling er tilgængelig på innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. Som anført på dette websted kan anmodninger om adgang til undersøgelsesdata indsendes via Yale Open Data Access (YODA) Project-webstedet på yoda.yale.edu

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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