GEN3013, Epcoritamab Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma EPCORE™ NHL-1

Overview

Información sobre este estudio

The purpose of the trial is to determine the maximum tolerated dose and the recommended phase 2 dose as well as to establish the safety profile of GEN3013 (DuoBody®-CD3xCD20) in patients with Relapsed, Progressive or Refractory B-Cell Lymphoma.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Main Inclusion Criteria Escalation Part

- Documented CD20+ mature B-cell neoplasm

1. Diffuse large B-cell lymphoma - de novo or transformed

2. High-grade B-cell lymphoma

3. Primary mediastinal large B-cell lymphoma

4. Follicular lymphoma

5. Mantle cell lymphoma

6. Small lymphocytic lymphoma

7. Marginal zone lymphoma (nodal, extranodal or mucosa associated)

- Relapsed, progressive and/or refractory disease following treatment with an anti-CD20
monoclonal antibody (e.g. rituximab) potentially in combination with chemotherapy
and/or relapsed after autologous stem cell rescue.

- ECOG performance status 0,1 or 2

- Patients must have measurable disease by CT, MRI or PET-CT scan

- Acceptable renal function

- Acceptable liver function

Main Inclusion Criteria Expansion Part

- Documented CD20 positive mature B cell neoplasm or CD20+ MCL

- Diffuse large B cell lymphoma, de novo or transformed (including double hit or triple
hit)

- Primary mediastinal large B cell lymphoma

- Follicular lymphoma grade 3B

- Histologic confirmed follicular lymphoma

- Marginal zone lymphomas

- Small lymphocytic lymphoma

- Mantle Cell Lymphoma (prior BTKi or intolerant to BTKi)

- At least 2 therapies including an anti CD20 monoclonal antibody containing
chemotherapy combination regimen

- Either failed prior autologous hematopoietic stem cell transplantation or ineligible
for autologous stem cell transplantation due to age or comorbidities

- At least 1 measurable site of disease based on CT, MRI or PET-CT scan with involvement
of 2 or more clearly demarcated lesions and or nodes

NOTE: Other protocol defined Inclusion criteria may apply.

Eligibility last updated 9/29/22. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Allison Rosenthal, D.O.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available
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CLS-20507296

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