Un estudio de JNJ-80948543, un anticuerpo de redirección de células T, en el linfoma no Hodgkin (LNH) y la leucemia linfocítica crónica (LLC)
Un estudio de fase 1, primero en humanos, de JNJ-80948543, un anticuerpo de redirección de células T, en participantes con LNH y 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).
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Macquarie University, Australia, 2109
- Macquarie University Hospital
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Melbourne, Australia, 3004
- The Alfred Hospital
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Nedlands, Australia, 6009
- Linear Clinical Research Ltd
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Randwick, Australia, 2031
- Scientia Clinical Research
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Copenhagen, Dinamarca, 2100
- Rigshospitalet
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Odense, Dinamarca, 5000
- Odense University Hospital
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California
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Duarte, California, Estados Unidos, 91010
- City of Hope
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New York
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New York, New York, Estados Unidos, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, Estados Unidos, 10029
- Icahn School of Medicine at Mount Sinai
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Sarah Cannon Research Institute
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Texas
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Houston, Texas, Estados Unidos, 77030
- The University of Texas MD Anderson Cancer Center
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San Antonio, Texas, Estados Unidos, 78229
- Texas Transplant Institute
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Washington
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Seattle, Washington, Estados Unidos, 98109
- Seattle Cancer Care Alliance
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Lille, Francia, 59037
- CHRU de Lille Hopital Claude Huriez
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Paris, Francia, 75005
- Institut Curie
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Strasbourg, Francia, 67033
- Institut de Cancerologie Strasbourg Europe ICANS
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Toulouse, Francia, 31059
- Institut Universitaire du cancer de Toulouse-Oncopole
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Haifa, Israel, 34362
- Carmel Medical Center
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Jerusalem, Israel, 9112001
- Hadassah Medical Center
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Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Center
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Kashiwa, Japón, 277 8577
- National Cancer Center Hospital East
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Nagoya, Japón, 464 8681
- Aichi Cancer Center
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Tokyo, Japón, 135 8550
- The Cancer Institute Hospital of JFCR
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Gdansk, Polonia, 80 214
- Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
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Skorzewo, Polonia, 60-185
- Aidport Sp z o o
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Chongqing, Porcelana, 400044
- Chongqing University Cancer Hospital
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Guangzhou, Porcelana, 510060
- Sun Yat Sen University Cancer Center
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Tianjin, Porcelana, 300060
- Tianjin cancer hospital
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Wuhan, Porcelana, 430030
- Union Hospital Tongji Medical College of Huazhong University of Science and Technology
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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. |
JNJ-80948543 will be administered as SC or IV injection. |
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Experimental: Part B: Cohort Expansion
Participants will receive JNJ-80948543 by SC or IV administration. |
JNJ-80948543 will be administered as SC or IV injection. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants with Dose-limiting Toxicity (DLT)
Periodo de tiempo: Up to 4 Years 3 months
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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
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Number of Participants with Adverse Events (AEs)
Periodo de tiempo: Up to 4 Years 3 months
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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
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Number of Participants with AE by Severity
Periodo de tiempo: Up to 4 Years 3 months
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Serum Concentration of JNJ-80948543
Periodo de tiempo: Up to 4 Years 3 months
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Serum samples will be analyzed to determine concentrations of JNJ-80948543 using a validated, specific, and sensitive method. |
Up to 4 Years 3 months
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Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543
Periodo de tiempo: Up to 4 Years 3 months
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Number of participants with presence of anti-drug antibodies of JNJ-80948543 will be assessed. |
Up to 4 Years 3 months
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Overall Response Rate (ORR)
Periodo de tiempo: Up to 4 Years 3 months
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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
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Complete Response (CR) Rate
Periodo de tiempo: Up to 4 Years 3 months
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CR rate is defined as the percentage of participants who achieve a best response of CR. |
Up to 4 Years 3 months
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Rate of VGPR or Better for Participants with Waldenstrom Macroglobulinemia (WM)
Periodo de tiempo: Up to 4 Years 3 months
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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
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Time to Response (TTR)
Periodo de tiempo: Up to 4 Years 3 months
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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
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Duration of Response (DOR)
Periodo de tiempo: Up to 4 Years 3 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. |
Up to 4 Years 3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Neoplasias
- Enfermedad crónica
- Atributos de la enfermedad
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Enfermedades hematológicas
- Enfermedades linfáticas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Leucemia de células B
- Linfoma
- Leucemia Linfoide
- Leucemia
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades hemic y linfáticas
- Leucemia Linfocítica Crónica De Células B
- Linfoma No Hodgkin
Otros números de identificación del estudio
- CR109174
- 2022-000685-18 (Número EudraCT)
- 80948543LYM1001 (Otro identificador: Janssen Research & Development, LLC)
- 2023-504187-42-00 (Identificador de registro: EUCT number)
- 2023 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .