Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05100316
• Other study ID #: 213033
• Status: Terminated
• Phase: Phase 2
• Start date: December 16, 2021
• Est. completion date: October 4, 2022

Study information

• Verified date: May 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: October 4, 2022
• Est. primary completion date: October 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Gainesville	Florida
United States	GSK Investigational Site	Springfield	Missouri
United States	GSK Investigational Site	Waterloo	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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