Uno studio su JNJ-88549968 per il trattamento delle neoplasie mieloproliferative con mutazione della calreticulina (CALR)
Uno studio primo nell'uomo sulla sicurezza, farmacocinetica e farmacodinamica di JNJ-88549968, un anticorpo bispecifico che reindirizza le cellule T per le neoplasie mieloproliferative con CALR mutato
The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D[s]) and optimal dosing schedule(s) of JNJ-88549968 in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s) in part 2 (Cohort Expansion). For U.S. sites: the purpose of this study is to characterize the safety and to determine the RP2D(s) and optimal dosing schedule(s) of JNJ-88549968 in Part 1 and part 1b (Dose Escalation), and to characterize the safety of JNJ-88549968 at the RP2D(s) in Part 2 and part 2b (Cohort Expansion), when given as monotherapy in essential thrombocythemia (ET) or myelofibrosis (MF), and with ruxolitinib or momelotinib in MF only.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Study Contact
- Numero di telefono: 844-434-4210
- Email: Participate-In-This-Study1@its.jnj.com
Luoghi di studio
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 4N1
- Reclutamento
- Arthur J E Child Comprehensive Cancer Centre
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1Z5
- Reclutamento
- Princess Margaret Cancer Centre University Health Network
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
- Completato
- Jewish General Hospital
-
-
-
-
-
Beijing, Cina, 100032
- Reclutamento
- Peking Union Medical College Hospital
-
Hangzhou, Cina, 310002
- Reclutamento
- The First Affiliated Hospital Zhejiang University School of Medicine
-
Tianjin, Cina, 301617
- Reclutamento
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
-
-
-
-
-
Paris, Francia, 75475
- Reclutamento
- Hopital Saint Louis
-
Pierre-Bénite, Francia, 69495
- Reclutamento
- CH LYON SUD - Hematology
-
Toulouse, Francia, 31059
- Reclutamento
- Institut Universitaire du Cancer Toulouse Oncopole
-
-
-
-
-
Aachen, Germania, 52074
- Reclutamento
- Universitaetsklinikum der RWTH Aachen
-
Berlin, Germania, 12203
- Reclutamento
- Charite Campus Benjamin Franklin
-
Essen, Germania, 45147
- Reclutamento
- Med. Universitatsklinik Essen
-
Hanover, Germania, 30625
- Reclutamento
- Medizinische Hochschule Hannover
-
Heidelberg, Germania, 69120
- Reclutamento
- Universitaetsklinikum Heidelberg
-
Regensburg, Germania, 93053
- Reclutamento
- Universitaetsklinikum Regensburg
-
-
-
-
-
Bunkyō City, Giappone, 113 8431
- Reclutamento
- Juntendo University Hospital
-
Kashiwa, Giappone, 277 8577
- Reclutamento
- National Cancer Center Hospital East
-
-
-
-
-
Haifa, Israele, 3436212
- Reclutamento
- Carmel Medical Center
-
Jerusalem, Israele, 9112001
- Reclutamento
- Hadassah University Hospita Ein Kerem
-
Ramat Gan, Israele, 5266202
- Reclutamento
- Sheba Medical Center
-
Tel Aviv, Israele, 64239
- Reclutamento
- Tel Aviv Sourasky Medical Center
-
-
-
-
-
Bologna, Italia, 40138
- Reclutamento
- Policlinico Sant'Orsola Malpighi
-
Milan, Italia, 21022
- Reclutamento
- Policlinico di Milano
-
-
-
-
-
London, Regno Unito, SE1 9RT
- Reclutamento
- Guy's and St Thomas' Hospital
-
London, Regno Unito, NW1 2PG
- Reclutamento
- University College London Hospitals Nhs Foundation Trust
-
Oxford, Regno Unito, OX3 7LE
- Reclutamento
- Churchill Hospital
-
-
-
-
-
Badalona, Spagna, 08916
- Reclutamento
- Hosp. Univ. Germans Trias I Pujol
-
Valencia, Spagna, 46010
- Reclutamento
- Hosp. Clinico Univ. de Valencia
-
-
-
-
Arizona
-
Goodyear, Arizona, Stati Uniti, 85338
- Reclutamento
- City of Hope Phoenix
-
-
California
-
Duarte, California, Stati Uniti, 91010
- Reclutamento
- City of Hope
-
-
Colorado
-
Aurora, Colorado, Stati Uniti, 80045
- Reclutamento
- UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center
-
-
Florida
-
Tampa, Florida, Stati Uniti, 33612
- Reclutamento
- Moffit Cancer center
-
-
Georgia
-
Atlanta, Georgia, Stati Uniti, 30322
- Reclutamento
- Emory University
-
-
Illinois
-
Zion, Illinois, Stati Uniti, 60099
- Reclutamento
- City of Hope Chicago
-
-
Michigan
-
Ann Arbor, Michigan, Stati Uniti, 48109
- Reclutamento
- University of Michigan
-
Grand Rapids, Michigan, Stati Uniti, 49546
- Reclutamento
- Start Midwest
-
-
New Jersey
-
East Brunswick, New Jersey, Stati Uniti, 08816
- Reclutamento
- START New Jersey
-
New Brunswick, New Jersey, Stati Uniti, 08901
- Reclutamento
- Rutgers Cancer Institute of New Jersey
-
-
New York
-
New York, New York, Stati Uniti, 10065
- Reclutamento
- Memorial Sloan Kettering Cancer Center
-
The Bronx, New York, Stati Uniti, 10467
- Reclutamento
- Montefiore Medical Center
-
-
North Carolina
-
Charlotte, North Carolina, Stati Uniti, 28204
- Reclutamento
- Levine Cancer Institute
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stati Uniti, 19104
- Reclutamento
- University of Pennsylvania
-
-
South Carolina
-
Greenville, South Carolina, Stati Uniti, 29605
- Reclutamento
- Prisma Health
-
-
Tennessee
-
Nashville, Tennessee, Stati Uniti, 37203
- Reclutamento
- Sarah Cannon Cancer Institute
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- Reclutamento
- MD Anderson Cancer Center
-
-
Washington
-
Seattle, Washington, Stati Uniti, 98104
- Reclutamento
- Swedish Cancer Institute
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Be greater than or equal to (>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever the greater) at the time of informed consent
- Positive for a calreticulin (CALR) driver mutation of essential thrombocythemia (ET) or myelofibrosis (MF)
- Participants with ET and MF with risk characteristics as described in the protocol
- Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of less than or equal to (<=) 2
- For US sites: Eligible for ruxolitinib therapy as per drug label for participants naive to a janus kinase (JAK) inhibitor
Exclusion Criteria:
-
Known allergies, hypersensitivity, or intolerance to the excipients of the study treatment
-
Concurrent or recently diagnosed or treated malignancies present at the time of participant screening. Exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix, and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of first dose of study treatment in the opinion of both the investigator and sponsor's medical monitor. Participants cured of another malignant disease with no sign of relapse greater than or equal to (>=) 3 years after treatment ended are allowed to enter the study
-
Prior solid organ transplantation
-
Either of the following regarding hematopoietic stem cell transplantation:
- Prior treatment with allogenic stem cell transplant less than or equal to (<=) 6 months before the first dose of JNJ-88549968 or
- Evidence of graft versus host disease (GVHD) that requires immunosuppressant therapy
-
History of clinically significant cardiovascular disease within 6 months prior to the first dose of study treatment
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Dose Escalation (Part 1), Dose Expansion (Part 2) and Part 1b (US only), Part 2b (US only)
In dose escalation (Part 1), participants will receive JNJ-88549968. For myelofibrosis (MF) participants only, the study will explore a Phase 1b cohort in which the janus kinase (JAK) inhibitor ruxolitinib or momelotinib is started in combination with JNJ-88549968. The dose will be escalated sequentially to determine the recommended phase 2 dose (RP2D) and optimal dosing schedule (s) based on safety, pharmacokinetic, pharmacodynamic, and preliminary assessment of efficacy across several dose regimens. Additional Cohorts may be added to assess different formulation or delivery methods. In dose expansion (Part 2, Part 2b [US only]), participants will receive JNJ-88549968 at the RP2D regimen(s) determined in dose escalation (Part 1, Part 1b [US only]). |
JNJ-88549968 will be administered. For US sites: Ruxolitinib will be administered for participants with MF only. For US sites: Momelotinib will be administered for participants with MF only. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Part 1, Part 1b (US Only): Number of Participants With Dose Limiting Toxicity (DLT)
Lasso di tempo: Approximately up to 35 days after first dose of study treatment
|
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. For US only: A DLT is any adverse event attributed to study treatment that meets the criteria for severity and duration and that occurs during the evaluation periods unless it can be incontrovertibly attributed to disease or other extraneous cause such as an accident. |
Approximately up to 35 days after first dose of study treatment
|
|
Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs)
Lasso di tempo: Up to 2 years
|
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
Up to 2 years
|
|
Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs) by Severity
Lasso di tempo: Up to 2 years
|
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. Cytokine release syndrome (CRS) and associated neurologic toxicity events (immune effector cell-associated neurotoxicity syndrome events [ICANS]) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. |
Up to 2 years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Part 1, 2, Part 1b (US Only), Part 2b (US Only): Serum Concentration of JNJ-88549968
Lasso di tempo: Up to 2 years
|
Serum samples will be analyzed to determine concentrations of JNJ-88549968. |
Up to 2 years
|
|
Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants With Presence of Anti-Drug Antibodies to JNJ-88549968
Lasso di tempo: Up to 2 years
|
Number of participants with presence of anti-drug antibodies to JNJ-88549968 will be reported. |
Up to 2 years
|
|
Part 1, 2, Part 1b (US Only), Part 2b (US Only): Overall Response Rate
Lasso di tempo: Up to 2 years
|
ORR is defined as the percentage of participants who achieve partial response (PR) and complete response (CR) according to modified International Working Group-Myeloproliferative Neoplasm Research and Treatment (IWG-MRT) criteria and modified European Leukemia Net (ELN) consensus report. |
Up to 2 years
|
|
Part 1, 2, Part 1b (US Only), Part 2b (US Only): Complete Response (CR) Rate
Lasso di tempo: Up to 2 years
|
CR rate is defined as the percentage of participants who achieve a best response of CR according to disease as defined in modified IWG-MRT criteria and modified ELN consensus report. |
Up to 2 years
|
|
Part 1, 2, Part 1b (US Only), Part 2b (US Only): Time to Response (TTR)
Lasso di tempo: Up to 2 years
|
TTR is defined for participants who achieved PR or CR as the time from the first dose of study treatment to first response of PR or CR according to modified IWG-MRT criteria and modified ELN consensus report. |
Up to 2 years
|
|
Part 1, 2, Part 1b (US Only), Part 2b (US Only): Duration of Response (DOR)
Lasso di tempo: Up to 2 years
|
DOR is defined for participants who achieved PR or CR as the time between the date of initial documentation of PR or CR to the date of first documented evidence of disease progression, as defined in modified IWG-MRT criteria and modified ELN consensus report, or death, whichever comes first. |
Up to 2 years
|
|
Part 2, Part 2b (US Only): Change From Baseline in Myeloproliferative Neoplasm (MPN) Symptom Burden
Lasso di tempo: Baseline up to 2 years
|
Change from baseline in MPN symptom burden assessed using patient reported outcome (PRO) questionnaire will be reported in this outcome measure. |
Baseline up to 2 years
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 88549968MPN1001
- 2023-505584-36-00 (Identificatore di registro: EUCT number)
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
- 88549968MPN1001 (Altro identificatore: Janssen Research & Development, LLC)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .