Une étude du JNJ-88998377 pour le lymphome non hodgkinien à cellules B récidivant/réfractaire
Une étude de phase 1, la première chez l'homme, avec augmentation de dose du JNJ-88998377 chez des participants atteints de lymphome non hodgkinien (LNH) à cellules B en rechute/réfractaire
The main purpose of this study is to characterize safety and to determine the recommended phase 2 dose (RP2D) for JNJ-88998377 (Part A: Dose Escalation), to further assess the safety of JNJ-88998377 at the RP2D (Part B: Dose Expansion).
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Beijing, Chine, 100142
- Beijing Cancer Hospital
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Guangzhou, Chine, 510062
- Sun Yat Sen University Cancer Center
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Hangzhou, Chine, 310002
- The First Affiliated Hospital Zhejiang University College of Medicine
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Shanghai, Chine, 200032
- Fudan University Shanghai Cancer Center
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Tianjin, Chine, 300181
- Tianjin Medical University Cancer Institute and Hospital
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Seoul, Corée du Sud, 03080
- Seoul National University Hospital
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Seoul, Corée du Sud, 06351
- Samsung Medical Center
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Bologna, Italie, 40138
- A O U Sant Orsola Malpighi
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Chūōku, Japon, 104 0045
- National Cancer Center Hospital
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Kashiwa, Japon, 277-8577
- National Cancer Center Hospital East
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Tokyo, Japon, 135 8550
- The Cancer Institute Hospital of JFCR
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Katowice, Pologne, 40 519
- Pratia Onkologia Katowice
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Kielce, Pologne, 25-734
- Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Klinika Hematologii i Transplantacji Szpiku
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Skorzewo, Pologne, 60-185
- Aidport Sp z o o
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Taipei, Taïwan, 10043
- National Taiwan University Hospital
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Taoyuan, Taïwan, 33382
- Linkou Chang Gung Memorial Hospital
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Ankara, Turquie (Türkiye), 06200
- SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi
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Ankara, Turquie (Türkiye), 06620
- Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi
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Istanbul, Turquie (Türkiye), 34010
- Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Participants have histologically or cytologically confirmed B-cell non-Hodgkin's Lymphoma (NHL) according to the 2022 World Health Organization (WHO) classification with relapsed or refractory disease
- Participants have measurable disease or meet all requirements for adequate response assessment as defined by the appropriate disease response criteria at screening
- Participants have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Participants have a life expectancy of greater than or equal to (>=) 12 weeks
- Be willing and able to adhere to the lifestyle restrictions specified in the protocol
Exclusion Criteria:
- Participant with active or prior history of B-cell NHL involving the central nervous system (CNS) and leptomeningeal involvement
- History of malignancy (other than the disease under study in the cohort to which the participant is assigned) within 1 year prior to the first administration of study treatment.
- For Part A and B: Participant having known allergies, hypersensitivity, or intolerance to the excipients of JNJ-88998377
- Participant had major surgery or had significant traumatic injury within 30 days before first dose of study treatment or has not recovered from surgery and must not have major surgery planned during the time the participant is receiving study treatment
- Participant received an autologous stem cell transplant less than or equal to (<=) 3 months before the first dose of study treatment
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Part A: Dose Escalation
Participants will receive JNJ-88998377 at a selected starting dose. Subsequent dose levels and schedules will be selected based on the review of all available data to establish recommended Phase 2 dose (RP2D). |
JNJ-88998377 will be administered. |
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Expérimental: Part B: Dose Expansion
Participants will receive JNJ-88998377 at RP2D determined in Part A. Additional expansion cohort(s) may be added with a lower RP2D(s), or different dose schedule(s) based on all available data. |
JNJ-88998377 will be administered. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Parts A and B: Number of Participants with Adverse Events (AEs)
Délai: Upto 3 years 4 months
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product. |
Upto 3 years 4 months
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Part A: Number of Participants with Dose Limiting Toxicity (DLTs)
Délai: Cycle 1 (21 days)
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Number of participant with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematological or hematological toxicity. |
Cycle 1 (21 days)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Plasma Concentration of JNJ-88998377
Délai: Up to first 12 weeks
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Plasma concentration of oral dose of JNJ-88998377 will be assessed. |
Up to first 12 weeks
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Area Under the Plasma Concentration Versus Time Curve During A Dosing Interval (τ) At Steady-State of JNJ-88998377
Délai: Up to first 12 weeks
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Area under the plasma concentration versus time curve during a dosing interval (τ) at steady-state concentration of JNJ-88998377 will be reported. |
Up to first 12 weeks
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Maximum Plasma Concentration (Cmax) of JNJ-88998377
Délai: Up to first 12 weeks
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Cmax of JNJ-88998377 will be reported. |
Up to first 12 weeks
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Minimum Plasma Drug Concentration (Cmin) of JNJ-88998377
Délai: Up to first 12 weeks
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Cmin of JNJ-88998377 will be reported. |
Up to first 12 weeks
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Percentage of Participants With Overall Response (OR)
Délai: Up to 3 years 4 months
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OR is defined as the percentage of participants who have a best response of partial response (PR) or better per investigator assessment according to disease-specific response criteria. |
Up to 3 years 4 months
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Time to Response (TTR)
Délai: From first dose of study treatment until first response of PR or better (up to 3 years and 4 months)
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TTR is defined for participants who achieved a response of PR or better as the time from the first dose of study treatment to the first response of PR or better per investigator assessment according to disease-specific response criteria. |
From first dose of study treatment until first response of PR or better (up to 3 years and 4 months)
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Duration of Response (DOR)
Délai: From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months)
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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. |
From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months)
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 88998377LYM1001
- 88998377LYM1001 (Autre identifiant: Janssen Research & Development, LLC)
- 2023-509258-71-00 (Identificateur de registre: EUCT number)
- 2023 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at 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
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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