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

27. srpna 2026 aktualizováno: 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).

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

360

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: JNJ-95804306
JNJ-95804306 will be administered orally.
Lék: AML SoC
AML SoC will be administered subcutaneously/intravenously.
Experimentální: 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.
Lék: JNJ-95804306
JNJ-95804306 will be administered orally.
Lék: CLL/SLL SoC
CLL/SLL SoC will be administered orally/ intravenously.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants with Adverse Events (AEs) by Severity
Časové okno: 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)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
For US sites: Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: Up to 6 years 5 months
Participants with BOR based on indication-specific criteria will be reported.
Up to 6 years 5 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Janssen Research & Development, LLC

Vyšetřovatelé

  • Ředitel studie: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

13. května 2026

Primární dokončení (Odhadovaný)

18. května 2029

Dokončení studie (Odhadovaný)

24. září 2032

Termíny zápisu do studia

První předloženo

30. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

30. dubna 2026

První zveřejněno (Aktuální)

7. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 95804306EDI1001 (Jiný identifikátor: Janssen Research & Development, LLC)
  • 2026-525234-39 (Číslo EudraCT)
  • 2026-525234-39-00 (Identifikátor registru: EUCT number)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ano

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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