Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials

Phase 2

Terminated

• Conditions: Neoplasms

• Registration Number: NCT05100316
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-29
• Study Start: 2021-12-16
• Primary Completion: 2022-10-04
• Study Completion: 2022-10-04
• Status Verified: 2023-05
• Results First Submitted: 2023-05-24
• Results First Submitted QC: 2023-05-24
• Last Update Submitted: 2023-05-24
• Results First Posted: 2024-02-05
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Springfield, Missouri, United States