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

27 sierpnia 2026 zaktualizowane przez: 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).

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

360

Faza

  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: JNJ-95804306
JNJ-95804306 will be administered orally.
Lek: AML SoC
AML SoC will be administered subcutaneously/intravenously.
Eksperymentalny: 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.
Lek: JNJ-95804306
JNJ-95804306 will be administered orally.
Lek: CLL/SLL SoC
CLL/SLL SoC will be administered orally/ intravenously.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants with Adverse Events (AEs) by Severity
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
For US sites: Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Up to 6 years 5 months
Participants with BOR based on indication-specific criteria will be reported.
Up to 6 years 5 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Janssen Research & Development, LLC

Śledczy

  • Dyrektor Studium: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

13 maja 2026

Zakończenie podstawowe (Szacowany)

18 maja 2029

Ukończenie studiów (Szacowany)

24 września 2032

Daty rejestracji na studia

Pierwszy przesłany

30 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

30 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

7 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 95804306EDI1001 (Inny identyfikator: Janssen Research & Development, LLC)
  • 2026-525234-39 (Numer EudraCT)
  • 2026-525234-39-00 (Identyfikator rejestru: EUCT number)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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