Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05100316
Collaborator
(none)
125
3
1
11.5
41.7
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Screening Platform
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
125 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Dec 16, 2021
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Prevalence of Human Leukocyte Antigen (HLA) genotypes (HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06) [Up to 2 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Gainesville Florida United States 32608
2 GSK Investigational Site Waterloo Iowa United States 50703
3 GSK Investigational Site Springfield Missouri United States 65807

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT05100316
Other Study ID Numbers:
  • 213033
First Posted:
Oct 29, 2021
Last Update Posted:
Apr 29, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GlaxoSmithKline

Study Results

No Results Posted as of Apr 29, 2022