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En studie av JNJ-79635322 hos deltakere med residiverende eller refraktært myelomatose

2. november 2026 oppdatert av: Janssen Research & Development, LLC

Fase 1, første-i-menneske, doseeskaleringsstudie av JNJ-79635322, et trispesifikt antistoff, hos deltakere med residiverende eller refraktært myelomatose

The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

180

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Belgia
      • Edegem, Belgia, 2650
        • Rekruttering
        • UZ Antwerpen
      • Ghent, Belgia, 9000
        • Rekruttering
        • UZ Gent
      • Liège, Belgia, 4000
        • Rekruttering
        • CHU de Liege
  • Forente stater
    • California
      • Duarte, California, Forente stater, 91010
        • Rekruttering
        • City of Hope
      • Irvine, California, Forente stater, 92618
        • Rekruttering
        • City of Hope Orange County Lennar Foundation Cancer Center
      • San Francisco, California, Forente stater, 94143
        • Rekruttering
        • University of California San Francisco
    • Colorado
      • Denver, Colorado, Forente stater, 80218
        • Rekruttering
        • Colorado Blood Cancer Institute
    • New York
      • New York, New York, Forente stater, 10065
        • Rekruttering
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, Forente stater, 10029
        • Rekruttering
        • Icahn School of Medicine at Mt. Sinai
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28001
        • Rekruttering
        • Levine Cancer Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Rekruttering
        • University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • MD Anderson Cancer Center
  • Frankrike
      • Nantes, Frankrike, 44093
        • Rekruttering
        • CHU Nantes
      • Pierre-Bénite, Frankrike, 69495
        • Rekruttering
        • CHU Lyon Sud
      • Rennes, Frankrike, 35000
        • Fullført
        • Chu Rennes Hopital Pontchaillou
      • Toulouse, Frankrike, 31100
        • Rekruttering
        • Institut Claudius Regaud
  • Japan
      • Shibuya City, Japan, 150-8935
        • Aktiv, ikke rekrutterende
        • Japanese Red Cross Medical Center
      • Suita-shi, Japan, 565-0871
        • Aktiv, ikke rekrutterende
        • Osaka University Hospital
      • Tokyo, Japan, 135-8550
        • Fullført
        • The Cancer Institute Hospital of JFCR
  • Nederland
      • Amsterdam, Nederland, 1081 HV
        • Rekruttering
        • VUMC Amsterdam
      • Groningen, Nederland, 9713 GZ
        • Rekruttering
        • Universitair Medisch Centrum Groningen
      • Utrecht, Nederland, 3584 CX
        • Rekruttering
        • UMC Utrecht
  • Spania
      • Badalona, Spania, 08916
        • Rekruttering
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, Spania, 08036
        • Rekruttering
        • Hosp Clinic de Barcelona
      • Madrid, Spania, 28040
        • Rekruttering
        • Hosp Univ Fund Jimenez Diaz
      • Pamplona, Spania, 31008
        • Rekruttering
        • Clinica Univ. de Navarra
      • Salamanca, Spania, 37007
        • Rekruttering
        • Hosp Clinico Univ de Salamanca
  • Storbritannia
      • London, Storbritannia, W1T 7HA
        • Rekruttering
        • University College Hospital
      • Sutton, Storbritannia, SM2 5PT
        • Rekruttering
        • Royal Marsden Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

For participants with relapsed or refractory multiple myeloma:

  • Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Part 1: Have relapsed or refractory disease, have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM),and should have been treated with at least 3 prior lines of therapy, or are refractory to proteosome inhibitor, IMiD agent, and an anti-CD38-based therapy regardless of prior lines of therapy, Part 2: Have relapsed or refractory disease, have been treated with a PI, IMiD and an anti-CD38 based therapy
  • Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
  • Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); or b) Urine M-protein level >=200 milligrams (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio; d) For participants without measurable disease in the serum, urine, or involved FLC, presence of 1 or more focus of extramedullary disease (EMD) which meets the following criteria: extramedullary plasmacytoma not contiguous with a bone lesion, at least 1 lesion >=2 centimeter [cm] (at its greatest dimension) diameter on whole body Positron Emission Tomography and Computed Tomography (PET-CT) Scans (or whole body magnetic resonance imaging [MRI] approved by sponsor), and not previously radiated (Part 2C participants are not required to have measurable disease)

For participants with previously treated AL amyloidosis:

  • Initial histopathological diagnosis of amyloidosis
  • Participant who is not a candidate for available AL amyloidosis therapy with established clinical benefit and should have received at least 3 cycles of 1 prior line of therapy or a total of at least 2 cycles of 2 or more prior lines of therapy for AL amyloidosis
  • Measurable disease at screening defined by at least 1 of the following: serum involved free light chain (iFLC) >=50 mg/L or difference between involved and uninvolved free light chains (dFLC) >=50 mg/L, or serum m-protein >= 0.5 g/dL
  • One or more organs impacted by systemic AL amyloidosis
  • Left ventricular ejection fraction (LVEF) >=45%

Exclusion Criteria:

For participants with relapsed or refractory multiple myeloma:

  • Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
  • Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis
  • Received a cumulative dose of corticosteroids equivalent to greater than (>) 140 mg of prednisone within the 14-day period before the start of study treatment administration
  • Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment: (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days [not applicable for Part 2C participants], or CD3-redirecting therapy within 21 days[not applicable for Part 2B or 2C participants])
  • Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
  • Live, attenuated vaccine within 4 weeks before the first dose of study treatment
  • Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy to Grade <=3)
  • The following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency (HIV) infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, autoimmune disease, serious active viral or bacterial infection, uncontrolled systemic fungal infection, cardiac conditions (myocardial infarction <=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, et cetera)
  • Part 2C: have progressive disease or refractory disease per IMWG after CAR-T administration

For participants with previously treated AL amyloidosis:

  • CNS involvement or clinical signs of meningeal involvement of AL amyloidosis. If either is suspected, whole brain MRI and lumbar cytology are required
  • Any form of non-AL amyloidosis, including but not limited to transthyretin (ATTR) amyloidosis
  • Active plasma cell leukemia, Waldenstrom's macroglobulinemia, or POEMS syndrome
  • Pulmonary compromise requiring supplemental oxygen use
  • Any serious medical conditions such as: active viral, bacterial, fungal infection; active autoimmune disease; HIV infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, significant cardiovascular conditions
  • Previous or current diagnosis of symptomatic multiple myeloma
  • Macroglossia that impairs swallowing difficulty
  • Received a cumulative dose of corticosteroids equivalent to > 140 mg of prednisone within the 14-day period before the start of study treatment administration
  • Prior antitumor therapy within 21 days prior to the first dose of study treatment (PI therapy or radiotherapy within 14 days, IMiD agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days, or CD3-redirecting therapy within 21 days)
  • Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
  • Live, attenuated vaccine within 4 weeks before the first dose of study treatment
  • Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to <=1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy to Grade <=3)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Part 1: Dose Escalation

Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified.
Legemiddel: JNJ-79635322

JNJ-79635322 will be administered as SC injection.
Eksperimentell: Part 2: Dose Expansion

Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1.
Legemiddel: JNJ-79635322

JNJ-79635322 will be administered as SC injection.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
Tidsramme: Up to 2 years 5 months

DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Up to 2 years 5 months
Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity
Tidsramme: Up to 2 years 5 months

An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
Up to 2 years 5 months
Part 2: Number of Participants with Abnormalities in Laboratory Values
Tidsramme: Up to 2 Years 5 months

Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported.
Up to 2 Years 5 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Serum Concentration of JNJ-79635322
Tidsramme: Up to 2 Years 5 months

Serum samples will be analyzed to determine concentrations of JNJ-79635322.
Up to 2 Years 5 months
Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322
Tidsramme: Up to 2 Years 5 months

Number of participants with presence of anti-drug antibodies to JNJ-79635322 will be reported.
Up to 2 Years 5 months
Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Myeloma Working Group (IMWG) 2016 Response Criteria
Tidsramme: Up to 2 Years 5 months

Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.
Up to 2 Years 5 months
Time to Response (TTR) as Defined by IMWG 2016 Response Criteria
Tidsramme: Up to 2 Years 5 months

TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation at which the participant has met all criteria for partial response (PR) or better as defined by IMWG 2016 response criteria.
Up to 2 Years 5 months
Duration of Response (DOR) as Defined by IMWG 2016 Response Criteria
Tidsramme: Up to 2 Years 5 months

DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG 2016 response criteria, or death due to any cause, whichever occurs first.
Up to 2 Years 5 months
Part 2: Time to Response (TTR) as Defined by International Amyloidosis Consensus Criteria
Tidsramme: Up to 2 Years 5 months

TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation at which the participant has met all criteria for PR or better as defined by International Amyloidosis Consensus Criteria.
Up to 2 Years 5 months
Part 2: Duration of Response (DOR) as Defined by International Amyloidosis Consensus Criteria
Tidsramme: Up to 2 Years 5 months

DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per International Amyloidosis Consensus Criteria or death due to any cause, whichever occurs first.
Up to 2 Years 5 months
Part 2: Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Amyloidosis Consensus Criteria
Tidsramme: Up to 2 Years 5 months

Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Amyloidosis Consensus Criteria.
Up to 2 Years 5 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Janssen Research & Development, LLC

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. november 2022

Primær fullføring (Antatt)

19. april 2027

Studiet fullført (Antatt)

15. november 2030

Datoer for studieregistrering

Først innsendt

7. desember 2022

Først innsendt som oppfylte QC-kriteriene

7. desember 2022

Først lagt ut (Faktiske)

15. desember 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR109234
  • 2022-001465-12 (EudraCT-nummer)
  • 79635322MMY1001 (Annen identifikator: Janssen Research & Development, LLC)
  • 2023-503679-12-00 (Registeridentifikator: EUCT number)
  • 2023 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere