A Screening Protocol to Support Preliminary Eligibility for Clinical Trials Evaluating Safety and Efficacy of Adoptive Cell Therapies in Participants With Solid Tumors and Hematologic Malignancies

GlaxoSmithKline1 site in 1 country16 target enrollmentDecember 16, 2021

ConditionsNeoplasms

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Neoplasms
Sponsor: GlaxoSmithKline
Enrollment: 16
Locations: 1
Primary Endpoint: Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This screening study is intended to determine preliminary eligibility of participants who may be potential candidates for GlaxoSmithKline's Adoptive T-cell therapy studies by screening for appropriate biomarkers. No treatment intervention will occur as part of this screening study.

Registry

clinicaltrials.gov

Start Date

December 16, 2021

End Date

October 4, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed diagnosis of locally advanced high-risk eligible tumor types .
•Participant must be greater than or equal to (\>=)18 years of age (or \>=10 years of age with synovial sarcoma or myxoid/round cell liposarcoma \[MRCLS\])
•Participants with life expectancy of greater than 6 months
•Performance status: Eastern Cooperative Oncology Group 0-1.

Exclusion Criteria

•Any prior treatment with oncology cell and/or gene therapy (unless agreed in advance with Sponsor)
•Prior malignancy not in complete remission.
•Clinically significant systemic illness
•Serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction,
•Prior or active demyelinating disease
•Previous New-York Esophageal Antigen-1 (NY-ESO-1)-specific T cells, NY-ESO-1 vaccine, or NY-ESO-1 targeting antibody.
•Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant.

Outcomes

Primary Outcomes

Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status

Time Frame: Up to 2 weeks

Blood samples were collected for HLA compatibility testing. Number of participants with eligible human leukocyte antigen (HLA) A genotypes status are presented. Data has been reported for following categories: One HLA Allele Positive, Two HLA Allele Positive, Negative and Ambiguous.