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

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Steven Attia, D.O.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.

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