Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials

NCT05100316 | Terminated Phase 2 Results

• 1 other identifier: 213033
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

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.

Conditions

Neoplasms

Keywords

Adoptive T-cell therapy; Hematologic Malignancy; Human leukocyte antigen; Screening study; Solid Tumors; T-cell receptors

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Participants with solid tumors and hematological malignancies

OTHER

Participants with solid tumors and hematological malignancies will be included. No study treatment will be administered in this study.

Other: Screening Platform

Interventions

Screening Platform OTHER

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.

Participants with solid tumors and hematological malignancies

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Gainesville, Florida, 32608, United States

Location

GSK Investigational Site

Waterloo, Iowa, 50701, United States

Location

GSK Investigational Site

Springfield, Missouri, 65807, United States

Location

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 29, 2021
• Study Start: December 16, 2021
• Primary Completion: October 4, 2022
• Study Completion: October 4, 2022
• Last Updated: February 5, 2024
• Results First Posted: February 5, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (3)