Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies

27. August 2026 aktualisiert von: Janssen Research & Development, LLC

A Phase 1, First-in-human, Dose Escalation Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies

The purpose of Part 1 (Dose Escalation) of the study is to assess how safe and tolerable JNJ-95804306 is and to find out the most suitable dose (recommended phase 2 dose [RP2D]) of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety of JNJ-95804306 and determine the anti-tumor activity alone and/or when administered in addition to standard of care (SoC) therapy at the putative RP2D(s) regimens in participants with hematological malignancies (cancer that begins in blood-forming tissue, such as the bone marrow, or in the cells of the immune system). For US sites: The purpose of Part 1 (Dose Escalation) of the study is to assess how safe and tolerable JNJ-95804306 is and to find out the most suitable dose (recommended phase 2 dose [RP2D]) of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety of JNJ-95804306 and determine the anti-tumor activity alone at the putative RP2D(s) regimens in participants with hematological malignancies (cancer that begins in blood-forming tissue, such as the bone marrow, or in the cells of the immune system).

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

360

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Australien
      • Melbourne, Australien, 3000
        • Rekrutierung
        • Peter MacCallum Cancer Centre
  • Belgien
      • Edegem, Belgien, 2650
        • Rekrutierung
        • UZ Antwerpen
  • Dänemark
      • Aarhus N, Dänemark, DK-8200
        • Rekrutierung
        • Aarhus University Hospital
  • Frankreich
      • Marseille, Frankreich, 13009
        • Rekrutierung
        • Institut Paoli Calmettes
      • Pierre-Bénite, Frankreich, 69495
        • Rekrutierung
        • CHU Lyon Sud
      • Toulouse, Frankreich, 31059
        • Rekrutierung
        • Institut Claudius Regaud
  • Spanien
      • Madrid, Spanien, 28040
        • Rekrutierung
        • Hosp Univ Fund Jimenez Diaz
      • Pamplona, Spanien, 31008
        • Rekrutierung
        • Clinica Univ. de Navarra
  • Vereinigte Staaten
    • Indiana
      • Indianapolis, Indiana, Vereinigte Staaten, 46237
        • Rekrutierung
        • Indiana Blood & Marrow Transplantation
    • Michigan
      • Grand Rapids, Michigan, Vereinigte Staaten, 49546
        • Rekrutierung
        • START MidWest
    • New Jersey
      • Piscataway, New Jersey, Vereinigte Staaten, 08854
        • Rekrutierung
        • Rutgers Cancer Institute of New Jersey
    • New York
      • New York, New York, Vereinigte Staaten, 10016
        • Rekrutierung
        • NYU Langone Health
    • Tennessee
      • Nashville, Tennessee, Vereinigte Staaten, 37203
        • Rekrutierung
        • Sarah Cannon Cancer Institute
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77030
        • Rekrutierung
        • MD Anderson Cancer Center - University of Texas
  • Vereinigtes Königreich
      • Manchester, Vereinigtes Königreich, M20 4BX
        • Rekrutierung
        • The Christie NHS Foundation Trust

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion criteria:

For Arm A:

  • Have a diagnosis of: Acute myeloid leukemia (AML) per International Consensus Classification (ICC) 2022 or myelodysplastic syndromes (MDS) per world health organization (WHO) 2022 classified as moderate high, high, or very high-risk per the molecular international prognostic scoring system (IPSSM). All participants must have relapsed or refractory disease and have exhausted or are ineligible for standard therapeutic options
  • Body weight greater than or equal to (>=) 40 kilograms (kg)
  • Eastern cooperative oncology group (ECOG) performance status of 0 to 2

For Arm B:

  • All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgement. Have a diagnosis of either: Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) meeting 2018 International workshop on chronic lymphocytic leukemia (iwCLL) National cancer institute (NCI) working group guidelines (Hallek 2018) that meet the following criteria:

    a. Participants must have received at least 2 prior lines of therapy; b. Have clinically measurable disease

  • Body weight >= 40 kg
  • ECOG performance status of 0 to 2
  • Must sign an Informed consent form (ICF)
  • For US sites: Have a diagnosis of CLL/SLL that meets iwCLL, NCI Working Group Guidelines which is relapsed or refractory and requires treatment with no other approved therapies available that would be more appropriate in the investigator's judgement. a. Participants must have received at least 2 prior lines of therapy

Exclusion criteria:

For Arm A:

  • Has acute promyelocytic leukemia according to world health organization (WHO) 2022 criteria or known active central nervous system (CNS) involvement of AML/MDS, unless in specific cohort (s) per study evaluation team (SET) decision
  • Need for supplemental oxygen use to maintain adequate oxygenation
  • Have evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted
  • For US sites: Has acute promyelocytic leukemia according to WHO 2022 criteria or known active CNS involvement of AML/MDS

For Arm B:

  • Need for supplemental oxygen use to maintain adequate oxygenation
  • Have evidence of uncontrolled systemic viral, bacterial, or fungal infection requiring initiation of parenteral treatment as medical intervention
  • Developed Richter's transformation or prolymphocytic leukemia
  • Known active CNS or leptomeningeal involvement of CLL/SLL/Non-Hodgkin lymphoma (NHL)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Arm A: R/R Acute Myeloid Leukemia (AML)/ High-Risk Myelodysplastic Syndrome (HR MDS)
Participants with relapsed/refractory (R/R) AML/HR-MDS will receive JNJ-95804306 monotherapy (Arm A1) or as an addition to standard of care (SoC) therapy in AML (Arm A2) to determine the putative recommended phase 2 dose (RP2D) in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy (Arm A1) or as an addition to SoC therapy in AML (Arm A2) at the determined RP2D regimen(s). For US sites: Participants with R/R AML/HR-MDS will receive JNJ-95804306 monotherapy to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy at the determined RP2D regimen(s). AML SoC will not be administered for US sites.
Arzneimittel: JNJ-95804306
JNJ-95804306 will be administered orally.
Arzneimittel: AML SoC
AML SoC will be administered subcutaneously/intravenously.
Experimental: Arm B: R/R Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) or NHL monotherapy
Participants with R/R CLL/SLL/NHL will receive JNJ-95804306 monotherapy (Arm B1) or as an addition to SoC therapy in R/R CLL/SLL (Arm B2 or B3) to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy (Arm B1) or as an addition to SoC therapy in R/R CLL/SLL (Arm B2 or B3) at the determined RP2D regimen(s). For US sites: Participants with R/R CLL/SLL/NHL will receive JNJ-95804306 monotherapy to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy at the determined RP2D regimen(s). CLL/SLL/NHL SoC will not be administered for US sites.
Arzneimittel: JNJ-95804306
JNJ-95804306 will be administered orally.
Arzneimittel: CLL/SLL SoC
CLL/SLL SoC will be administered orally/ intravenously.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants with Adverse Events (AEs) by Severity
Zeitfenster: Up to 6 years 5 months
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 6.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.
Up to 6 years 5 months
Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Zeitfenster: Up to 28 days after first full dose of study drug
DLT is defined as any toxicity that requires discontinuation of treatment; any toxicity resulting in dose reduction of study treatment, any toxicity resulting in a participant receiving less than (<) 2/3 of their intended dose; any grade 5 toxicity; non-hematologic toxicity (grade 3 or 4); and unacceptable hematologic toxicity.
Up to 28 days after first full dose of study drug

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
For US sites: Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Zeitfenster: Up to first 28 days after first dose of study drug
DLT is defined as any toxicity that requires discontinuation of treatment; any toxicity resulting in dose reduction of study treatment, any toxicity resulting in a participant receiving less than (<) 2/3 of their intended dose; any grade 5 toxicity; non-hematologic toxicity (grade 3 or 4); and unacceptable hematologic toxicity.
Up to first 28 days after first dose of study drug
Serum Concentrations of JNJ-95804306
Zeitfenster: Up to approximately 6 years 5 months
Serum samples will be analyzed to determine concentrations of JNJ-95804306.
Up to approximately 6 years 5 months
Area Under the Curve From Time of Administration until End of Dosing Interval (AUC[t]) of JNJ-95804306
Zeitfenster: Up to approximately 6 years 5 months
AUC[t] is defined as the area under the plasma concentration time curve during a dosing interval at steady-state.
Up to approximately 6 years 5 months
Maximum Plasma Concentration (Cmax) of JNJ-95804306
Zeitfenster: Up to approximately 6 years 5 months
Cmax is defined as the maximum serum concentration of JNJ-95804306.
Up to approximately 6 years 5 months
Minimum Plasma Concentration (Cmin) of JNJ-95804306
Zeitfenster: Up to approximately 6 years 5 months
Cmin is defined as the minimum plasma concentration of JNJ-95804306.
Up to approximately 6 years 5 months
Complete Response (CR) in Participants with Acute Myeloid Leukemia (AML)
Zeitfenster: Up to 6 years 5 months
Complete response (CR) is achieved when a participant with AML has a best response of CR (complete response with partial hematologic recovery [CRh] or complete response with incomplete hematologic recovery [CRi]) according to the European Leukemia Network (ELN) 2022 criteria.
Up to 6 years 5 months
Overall Response (OR) in Participants with Myelodysplastic Syndrome (MDS)
Zeitfenster: Up to 6 years 5 months
OR is achieved when a participant with MDS has a CR (any type, that is CRh or complete response with limited count recovery [CRL]), partial response (PR), or hematologic improvement (HI) according to the International Working Group (IWG) 2023 criteria.
Up to 6 years 5 months
Complete Response (CR) in Participants with MDS
Zeitfenster: Up to 6 years 5 months
CR is achieved when a participant with MDS has a best response of CR (including CRh/CRL) according to the IWG 2023 criteria.
Up to 6 years 5 months
Overall Response (OR) in Participants with Chronic Lymphocytic Leukemia (CLL)
Zeitfenster: Up to 6 years 5 months
OR is achieved when a participant with CLL has a CR or PR according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
Up to 6 years 5 months
Complete Response in Participants with CLL
Zeitfenster: Up to 6 years 5 months
Complete response as per iwCLL response criteria will be reported.
Up to 6 years 5 months
Duration of Response (DoR)
Zeitfenster: Up to 6 years 5 months
DOR is defined for responders only, as time from date of initial documentation of a response to the first documented evidence of no response, disease progression, relapse, initiation of a new systemic anti-cancer therapy (besides hematopoietic stem cell transplant [HSCT]), or death, whichever comes first.
Up to 6 years 5 months
Time to Response (TTR)
Zeitfenster: Up to 6 years 5 months
TTR is defined for responders only, as the time from the first dose of any study treatment to first qualifying response.
Up to 6 years 5 months
Overall Response in Participants with Non-Hodgkin Lymphoma (NHL) Subtypes Including Small Lymphocytic Lymphoma (SLL)
Zeitfenster: Up to 6 years 5 months
Overall response is achieved when a participant with NHL subtypes including SLL has a CR or PR according to the revised response criteria for malignant lymphoma.
Up to 6 years 5 months
Complete Response in Participants With NHL Subtypes Including SLL
Zeitfenster: Up to 6 years 5 months
Complete response is achieved when a participant with NHL subtypes including SLL has a best response of CR according to the revised response criteria for malignant lymphoma.
Up to 6 years 5 months
Overall Response in WM (Waldenstrom's Macroglobulinemia)
Zeitfenster: Up to 6 years 5 months
Overall response is achieved when a participant with WM has a CR or PR according to international workshop on waldenstrom's macroglobulinemia 2013
Up to 6 years 5 months
Complete Response in WM
Zeitfenster: Up to 6 years 5 months
Complete response is achieved when a participant with WM has a best response of CR according to international workshop on waldenstrom's macroglobulinemia 2013.
Up to 6 years 5 months
Best Overall Response (BOR) Based on Indication-Specific Criteria
Zeitfenster: Up to 6 years 5 months
Participants with BOR based on indication-specific criteria will be reported.
Up to 6 years 5 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Janssen Research & Development, LLC

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

13. Mai 2026

Primärer Abschluss (Geschätzt)

18. Mai 2029

Studienabschluss (Geschätzt)

24. September 2032

Studienanmeldedaten

Zuerst eingereicht

30. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. April 2026

Zuerst gepostet (Tatsächlich)

7. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 95804306EDI1001 (Andere Kennung: Janssen Research & Development, LLC)
  • 2026-525234-39 (EudraCT-Nummer)
  • 2026-525234-39-00 (Registrierungskennung: EUCT number)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren