Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials
Phase 2
Terminated
- Conditions
- Neoplasms
- Interventions
- Other: Screening Platform
- Registration Number
- NCT05100316
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participants with solid tumors and hematological malignancies Screening Platform Participants with solid tumors and hematological malignancies will be included. No study treatment will be administered in this study.
- Primary Outcome Measures
Name Time Method Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status Up to 2 weeks 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Springfield, Missouri, United States