Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials

Stopped early · Phase 2

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT05100316

Run by

GlaxoSmithKline

People needed

16

Starts

2021-12-16

Expected to finish

2022-10-04

Last updated by the study team

2024-02-05

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Gainesville, Florida, United States
• GSK Investigational Site — Waterloo, Iowa, United States
• GSK Investigational Site — Springfield, Missouri, United States

Full record on ClinicalTrials.gov

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