Master Protocol to Assess the Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Advanced Solid Tumors

Overview

Información sobre este estudio

The purpose of this trial is to evaluate the safety and effectiveness of first time in human engineered T-cell therapies, in participants with advanced tumors.

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.

Eligibility Criteria:

Inclusion criteria:

- Participant must be >=18 years of age on the day of signing informed consent

- Participant must be positive for HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 alleles

- Participant's tumor must have tested positive for NY-ESO-1/ LAGE-1a expression by a
GSK designated laboratory

- Performance status: Eastern Cooperative Oncology Group of 0-1

- Participant must have adequate organ function and blood cell counts 7 days prior to
leukapheresis

- Participant must have measurable disease according to RECIST v1.1.

Additional criteria for participants with synovial sarcoma/ MRCLS:

- Participant has advanced (metastatic or unresectable) synovial sarcoma or MRCLS
confirmed by local histopathology with evidence of disease-specific translocation

- Participant has received/completed treatment with anthracycline or with ifosfamide if
intolerant to anthracycline for advanced (metastatic or unresectable) disease and
progressed

Additional criteria for participants with non-small cell lung cancer (NSCLC):

- Participant has Stage IV NSCLC as confirmed by histology or cytology

- Participant has been previously treated with or is intolerant to programmed death
receptor-1 (PD)-1/Programmed death ligand 1 (PD-L1) checkpoint blockade therapy. For
NSCLC that harbors an actionable genetic aberration (BRAF, anaplastic lymphoma kinase
[ALK]/ c-ros oncogene 1 [ROS1]) per National Comprehensive Cancer Network (NCCN)
guidelines, participant has also been previously treated with or is intolerant to the
standard of care targeted therapy as recommended by NCCN or equivalent country-level
guidelines (European Society for Medical Oncology [ESMO], National Institute for
Health & Care Excellence [NICE])

Exclusion criteria:

- Central nervous system (CNS) metastases, with certain exceptions for CNS metastases in
NSCLC as specified in the protocol

- Any other prior malignancy that is not in complete remission

- Clinically significant systemic illness

- Prior or active demyelinating disease

- History of chronic or recurrent (within the last year prior to leukapheresis) severe
autoimmune or immune mediated disease requiring steroids or other immunosuppressive
treatments

- Previous treatment with genetically engineered NY-ESO-1-specific T cells, NY-ESO-1
vaccine or NY-ESO-1 targeting antibody

- Prior gene therapy using an integrating vector

- Previous allogeneic hematopoietic stem cell transplant within the last 5 years or
solid organ transplant

- Washout periods for prior radiotherapy and systemic chemotherapy must be followed

- Major surgery within 4 weeks prior to lymphodepletion

- Pregnant or breastfeeding females

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/23/22. 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

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Steven Attia, 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
.
CLS-20531302

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