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Een studie van JNJ-80948543, een T-celomleidend antilichaam, bij non-Hodgkin-lymfoom (NHL) en chronische lymfatische leukemie (CLL)

25 september 2026 bijgewerkt door: Janssen Research & Development, LLC

Een Fase 1, First-in-human studie van JNJ-80948543, een T-cel omleidend antilichaam, bij deelnemers met NHL en CLL

The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D[s]), optimal dosing schedule(s) and route(s) of administration of JNJ-80948543 in Part A (Dose Escalation) and to further characterize the safety of JNJ-80948543 at the putative RP2D(s) in Part B (Cohort Expansion).

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

167

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Australië
      • Macquarie University, Australië, 2109
        • Macquarie University Hospital
      • Melbourne, Australië, 3004
        • The Alfred Hospital
      • Nedlands, Australië, 6009
        • Linear Clinical Research Ltd
      • Randwick, Australië, 2031
        • Scientia Clinical Research
  • China
      • Chongqing, China, 400044
        • Chongqing University Cancer Hospital
      • Guangzhou, China, 510060
        • Sun Yat Sen University Cancer Center
      • Tianjin, China, 300060
        • Tianjin cancer hospital
      • Wuhan, China, 430030
        • Union Hospital Tongji Medical College of Huazhong University of Science and Technology
  • Denemarken
      • Copenhagen, Denemarken, 2100
        • Rigshospitalet
      • Odense, Denemarken, 5000
        • Odense University Hospital
  • Frankrijk
      • Lille, Frankrijk, 59037
        • CHRU de Lille Hopital Claude Huriez
      • Paris, Frankrijk, 75005
        • Institut Curie
      • Strasbourg, Frankrijk, 67033
        • Institut de Cancerologie Strasbourg Europe ICANS
      • Toulouse, Frankrijk, 31059
        • Institut Universitaire du cancer de Toulouse-Oncopole
  • Israël
      • Haifa, Israël, 34362
        • Carmel Medical Center
      • Jerusalem, Israël, 9112001
        • Hadassah Medical Center
      • Tel Aviv, Israël, 64239
        • Tel Aviv Sourasky Medical Center
  • Japan
      • Kashiwa, Japan, 277 8577
        • National Cancer Center Hospital East
      • Nagoya, Japan, 464 8681
        • Aichi Cancer Center
      • Tokyo, Japan, 135 8550
        • The Cancer Institute Hospital of JFCR
  • Polen
      • Gdansk, Polen, 80 214
        • Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
      • Skorzewo, Polen, 60-185
        • Aidport Sp z o o
  • Verenigde Staten
    • California
      • Duarte, California, Verenigde Staten, 91010
        • City of Hope
    • New York
      • New York, New York, Verenigde Staten, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, Verenigde Staten, 10029
        • Icahn School of Medicine at Mount Sinai
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, Verenigde Staten, 77030
        • The University of Texas MD Anderson Cancer Center
      • San Antonio, Texas, Verenigde Staten, 78229
        • Texas Transplant Institute
    • Washington
      • Seattle, Washington, Verenigde Staten, 98109
        • Seattle Cancer Care Alliance

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Histologic documentation of disease: B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) requiring therapy.

All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment.

B-cell NHL as defined per the 2016 world health organization (WHO) classification. In addition, the following disease-specific criteria outlined below must be met:

If diffuse large B-cell lymphoma (DLBCL) or other high-Grade B-cell lymphoma: Received, or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent or deemed not eligible or fit for an alternative 2nd line therapy. Participants may be eligible if relapsing after chimeric antigen receptors (CAR-T) cell treatment or while waiting for a CAR-T cell treatment.

If transformed lymphoma from low Grade B-cell malignancies: Received or not a candidate for an approved first-line regimen for DLBCL and received or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent.

If follicular lymphoma (FL) (all grades): Previously treated with a minimum of 2 prior lines of systemic therapy, with at least one prior line containing an anti-CD20 antibody.

If mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) (including nodal, extranodal/MALT, and splenic MZL subtypes): Previously treated with at least 2 lines of systemic therapy. H.pylori-positive gastric MALT lymphoma must have failed prior H. pylori eradication therapy as one of their prior lines .

Waldenstrom macroglobulinemia (WM): Previously treated with at least 1 line of systemic therapy.

small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL/SLL): Relapsed or refractory with at least 2 prior lines of therapy, including a Bruton tyrosine kinase inhibitor (BTK) inhibitor or a BCL2 inhibitor, if eligible. In addition for part B Participants must have measurable disease as defined by the appropriate disease response criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1
  • Cardiac parameters within the following range: corrected QT interval (QTc intervals corrected using Fridericia's formula [QTcF]) less than or equal to (<=) 480 milliseconds based on the average of triplicate assessments performed no more than 5 (plus minus [+-] 3) minutes apart
  • A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta- human chorionic gonadotropin) at screening and must agree to further serum or urine pregnancy tests prior to the first dose, during the study and until 3 months after the last dose of study treatment
  • A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study treatment

Exclusion Criteria:

  • Known active central nervous system (CNS) involvement; Lymphoma with CNS involvement may be allowed in pharmacokinetic/ pharmacodynamic (PK/PD) and expansion cohorts if approved by the study evaluation team (SET)
  • Prior solid-organ transplantation
  • Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug
  • Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade <= 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be Grade 2)
  • Clinically significant pulmonary compromise, particularly the need for supplemental oxygen use to maintain adequate oxygenation

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Part A: Dose Escalation

Participants will receive JNJ-80948543 either by subcutaneous (SC) or intravenous (IV) administration to determine the putative recommended Phase 2 dose (RP2D) dosing schedule(s) and route(s) of administration based on safety, pharmacokinetic, pharmacodynamic, and preliminary assessment of efficacy across several dose regimens.
Geneesmiddel: JNJ-80948543

JNJ-80948543 will be administered as SC or IV injection.
Experimenteel: Part B: Cohort Expansion

Participants will receive JNJ-80948543 by SC or IV administration.
Geneesmiddel: JNJ-80948543

JNJ-80948543 will be administered as SC or IV injection.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants with Dose-limiting Toxicity (DLT)
Tijdsspanne: Up to 4 Years 3 months

Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Up to 4 Years 3 months
Number of Participants with Adverse Events (AEs)
Tijdsspanne: Up to 4 Years 3 months

An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Up to 4 Years 3 months
Number of Participants with AE by Severity
Tijdsspanne: Up to 4 Years 3 months

Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 4 (Life-threatening). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded as per American Society for Transplantation and Cellular Therapy (ASTCT).
Up to 4 Years 3 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Serum Concentration of JNJ-80948543
Tijdsspanne: Up to 4 Years 3 months

Serum samples will be analyzed to determine concentrations of JNJ-80948543 using a validated, specific, and sensitive method.
Up to 4 Years 3 months
Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543
Tijdsspanne: Up to 4 Years 3 months

Number of participants with presence of anti-drug antibodies of JNJ-80948543 will be assessed.
Up to 4 Years 3 months
Overall Response Rate (ORR)
Tijdsspanne: Up to 4 Years 3 months

ORR is defined as the percentage of participants who have a best response of partial response (PR) or better.
Up to 4 Years 3 months
Complete Response (CR) Rate
Tijdsspanne: Up to 4 Years 3 months

CR rate is defined as the percentage of participants who achieve a best response of CR.
Up to 4 Years 3 months
Rate of VGPR or Better for Participants with Waldenstrom Macroglobulinemia (WM)
Tijdsspanne: Up to 4 Years 3 months

The response criteria planned to be used for participants with WM includes a category of VGPR, which is clinically understood to be better than PR but not as good as CR. For participants with WM, this rate is defined as the proportion of participants who achieve a best response of VGPR or better.
Up to 4 Years 3 months
Time to Response (TTR)
Tijdsspanne: Up to 4 Years 3 months

TTR is defined for participants who achieved PR or CR as the time from the first dose of study drug to first response of PR or CR.
Up to 4 Years 3 months
Duration of Response (DOR)
Tijdsspanne: Up to 4 Years 3 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 or death.
Up to 4 Years 3 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Janssen Research & Development, LLC

Onderzoekers

  • Studie directeur: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 augustus 2022

Primaire voltooiing (Werkelijk)

31 oktober 2025

Studie voltooiing (Geschat)

30 juli 2027

Studieregistratiedata

Eerst ingediend

15 juni 2022

Eerst ingediend dat voldeed aan de QC-criteria

15 juni 2022

Eerst geplaatst (Werkelijk)

21 juni 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 september 2026

Laatste update ingediend die voldeed aan QC-criteria

25 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CR109174
  • 2022-000685-18 (EudraCT-nummer)
  • 80948543LYM1001 (Andere identificatie: Janssen Research & Development, LLC)
  • 2023-504187-42-00 (Register-ID: EUCT number)
  • 2023 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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