Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials
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 |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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Outcome Measures
Primary Outcome Measures
- 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
Inclusion Criteria:
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Histologically or cytologically confirmed diagnosis of locally advanced high-risk eligible tumor types .
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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])
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Participants with life expectancy of greater than 6 months
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Performance status: Eastern Cooperative Oncology Group 0-1.
Exclusion Criteria:
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Any prior treatment with oncology cell and/or gene therapy (unless agreed in advance with Sponsor)
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Prior malignancy not in complete remission.
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Clinically significant systemic illness
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Serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction,
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Prior or active demyelinating disease
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Previous New-York Esophageal Antigen-1 (NY-ESO-1)-specific T cells, NY-ESO-1 vaccine, or NY-ESO-1 targeting antibody.
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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 | |
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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.- 213033