Un estudio de JNJ-87801493 en combinación con activadores de células T en participantes con cáncer linfoide no Hodgkin (LNH) de células B
Un primer estudio de fase 1 en humanos de JNJ-87801493 en combinación con activadores de células T CD3 en participantes con neoplasias malignas linfoides no Hodgkin (LNH) de células B en recaída o refractarias
The purpose of this study is to characterize safety and to determine the recommended phase 2 regimen (RP2R) for JNJ-87801493 in combination with T-cell engagers (TCEs) [Part A: Dose Escalation] and to further assess the safety of JNJ-87801493 at the RP2R in combination with TCEs [Part B: Dose Expansion].
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Heidelberg, Australia, 3084
- Austin Hospital
-
Melbourne, Australia, 3004
- The Alfred Hospital
-
Nedlands, Australia, 6009
- Linear Clinical Research Ltd
-
Randwick, Australia, 2031
- Scientia Clinical Research
-
-
-
-
-
Copenhagen, Dinamarca, DK-2100
- Rigshospitalet
-
Odense, Dinamarca, 5000
- Odense University Hospital
-
-
-
-
-
Barcelona, España, 08035
- Hosp Univ Vall D Hebron
-
Madrid, España, 28040
- Hosp Univ Fund Jimenez Diaz
-
Pamplona, España, 31008
- Clinica Univ. de Navarra
-
Salamanca, España, 37007
- Hosp Clinico Univ de Salamanca
-
-
-
-
-
Jerusalem, Israel, 9112001
- Hadassah Medical Center
-
Tel Aviv, Israel, 6423906
- Sourasky (Ichilov) Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Histologic documentation of B-cell NHL. All participants in part 1 must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment. In Part 2, participants with diffuse large B-cell lymphoma (DLBCL) or other high-grade B cell lymphoma and participants with transformed lymphoma from low-grade B cell malignancies who relapsed or failed to respond to only one prior systemic treatment regimen can be included
- Part 1 participants must have evaluable or measurable disease and Part 2 participants must have measurable disease; all as defined by the Lugano criteria for non-Hodgkin lymphoid malignancies (NHL) and the international workshop on Waldenstrom's Macroglobulinemia (IWWM-6) for WM
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Hematologic laboratory parameters must meet the required criterias and the values must be without a transfusion or growth factors for at least 7 days prior to the first dose of study drug
- Participants of childbearing potential must have a negative highly sensitive serum pregnancy test (beta (β)-human chorionic gonadotropin) at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.
Exclusion Criteria:
- Known active central nervous system involvement (CNS) or leptomeningeal involvement. CNS involvement may be allowed in specific cohorts as determined by the Study Evaluation Team (SET)
- Prior solid-organ transplantation
- Prior treatment with JNJ-80948543 and/or JNJ-75348780. In addition, history of known allergies, hypersensitivity, or intolerance to either JNJ-80948543, JNJ-75348780, or JNJ-87801493 or its excipients
- Chemotherapy, targeted therapy, or immunotherapy within 2 weeks before the first dose of study treatment. For investigational agents where the half-life is known, there should be a treatment-free window of at least 2 weeks or 5 half-lives. For checkpoint blockade therapy (example, anti-programmed cell death protein-1 [anti-PD-1]), a washout period of up to 6 weeks may be considered
- Malignancy diagnosis other than the disease under study within 1 year prior to 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 the study drugs in the opinion of both the investigator and sponsor's medical monitor
- Autoimmune or inflammatory disease requiring systemic corticosteroids or other immunosuppressive agents within 1 year prior to first dose of study treatment
- Evidence of active viral, bacterial, or uncontrolled systemic fungal infection requiring systemic treatment within 7 days before the first dose of study treatment
- Abnormal cardiac function
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 |
|---|---|
|
Experimental: Part 1: Dose escalation
Participants will receive one cycle of TCE monotherapy (step up dosing) with either JNJ-80948543 or JNJ-75348780 followed by initiation of combination therapy with JNJ-87801493 at least one week later. |
JNJ-87801493 will be administered subcutaneously. JNJ-80948543 will be administered subcutaneously. JNJ-75348780 will be administered subcutaneously. |
|
Experimental: Part 2:Dose expansion
Participants with specific B-cell NHL histologies will receive recommended phase 2 regimen (RP2R) of JNJ-87801493 with TCE as determined in Part 1. |
JNJ-87801493 will be administered subcutaneously. JNJ-80948543 will be administered subcutaneously. JNJ-75348780 will be administered subcutaneously. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)
Periodo de tiempo: Up to 2 years 7 months
|
Number of participants with DLTs will be reported. The DLTs are drug-related toxicities and are defined as any of the following: fatal toxicity, high grade non-hematologic toxicity, or hematologic toxicity |
Up to 2 years 7 months
|
|
Part 1 and 2: Percentage of Participants with Adverse Events (AEs) by Severity
Periodo de tiempo: Up to 2 years 7 months
|
An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity for AEs will be specified as per: NCI-CTCAE grades which are Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (potentially life-threatening) and; American Society for Transplantation and Cellular Therapy (ASTCT) guidelines which is Grade 5 (death related to adverse event); Cytokine release syndrome (CRS) and associated neurologic toxicity events (immune effector cell-associated neurotoxicity syndrome events [ICANS]). |
Up to 2 years 7 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Periodo de tiempo: Up to 2 years 7 months
|
Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
|
|
Area Under the Curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Periodo de tiempo: Up to 2 years 7 months
|
AUC tau is defined as area under the serum concentration-time curve during a dosing interval (tau).Area under the serum concentration curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
|
|
Maximum Serum Concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Periodo de tiempo: Up to 2 years 7 months
|
Maximum observed serum concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
|
|
Minimum Serum Concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Periodo de tiempo: Up to 2 years 7 months
|
Minimum observed serum concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
|
|
Area Under the Curve (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Periodo de tiempo: Up to 2 years 7 months
|
Area under the curve from time zero to t (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
|
|
Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Periodo de tiempo: Up to 2 years 7 months
|
Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
|
|
Time to Reach Cmax (Tmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Periodo de tiempo: Up to 2 years 7 months
|
Tmax is the time to reach maximum observed serum concentartion for JNJ-87801493, JNJ-80948543 and JNJ-75348780. |
Up to 2 years 7 months
|
|
Apparent Total Body Clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Periodo de tiempo: Up to 2 years 7 months
|
Apparent total body clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
|
|
Apparent Volume of Distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Periodo de tiempo: Up to 2 years 7 months
|
Apparent volume of distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
|
|
Number of Participants with Presence of Anti-JNJ-87801493, Anti-JNJ- 80948543 and Anti-JNJ-75348780 Antibodies
Periodo de tiempo: Up to 2 years 7 months
|
Number of participants with presence of antibodies binding to JNJ-87801493 or each combination partner (JNJ- 80948543 and JNJ-75348780). |
Up to 2 years 7 months
|
|
Overall Response as Assessed by the Investigator
Periodo de tiempo: Up to 2 years 7 months
|
Overall response is defined as a best response of partial response (PR) or better. |
Up to 2 years 7 months
|
|
Complete Response (CR) as Assessed by the Investigator
Periodo de tiempo: Up to 2 years 7 months
|
Complete response (CR) is defined as a best response of CR. |
Up to 2 years 7 months
|
|
Very Good Partial Response (VGPR) or better for Waldenström Macroglobulinemia (WM) Participants as Assessed by the Investigator
Periodo de tiempo: Up to 2 years 7 months
|
Very good partial response (VGPR) or better is defined as a best response of VGPR or better. |
Up to 2 years 7 months
|
|
Time to Response (TTR) as Assessed by the Investigator
Periodo de tiempo: Up to 2 years 7 months
|
Time to response (TTR) is defined for participants who achieve a response of PR or better as the time from the first dose of any study drug to the first response of PR or better. |
Up to 2 years 7 months
|
|
Duration of Response (DOR) as Assessed by the Investigator
Periodo de tiempo: Up to 2 years 7 months
|
Duration of response (DOR) is defined for participants who achieved a response of PR or better as the time from the first efficacy evaluation at which the participant meet all criteria for a response of PR or better to the date of first documented evidence of progressive disease or death. |
Up to 2 years 7 months
|
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
Otros números de identificación del estudio
- 87801493LYM1001
- 87801493LYM1001 (Otro identificador: Janssen Research & Development, LLC)
- 2023-505165-93-00 (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 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
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.
producto fabricado y exportado desde los 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. .