Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials

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

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.

Study Overview

• Status: Terminated
• Conditions: Neoplasms
• Intervention / Treatment: Other: Screening Platform

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • GSK Investigational Site
  • Iowa
    • Waterloo, Iowa, United States, 50701
      • GSK Investigational Site
  • Missouri
    • Springfield, Missouri, United States, 65807
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Participants with solid tumors and hematological malignancies; Participants with solid tumors and hematological malignancies will be included. No study treatment will be administered in this study.	Other: Screening Platform; Eligible participants who qualify as per this screening protocol may be referred to evaluate adoptive cell therapy in participants with various malignancies, on a separate treatment trial. No study treatment will be administered in this screening study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status	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.	Up to 2 weeks

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Actual): October 4, 2022
• Study Completion (Actual): October 4, 2022

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Solid Tumors; Hematologic Malignancy; Human leukocyte antigen; Adoptive T-cell therapy; T-cell receptors; Screening study
• Other Study ID Numbers: 213033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No