Last updated: 05/25/2023 12:10:19
Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
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
Trial description: 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.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Prevalence of Human Leukocyte Antigen (HLA) genotypes (HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06)
Timeframe: Up to 2 weeks
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
16
Primary completion date:
2022-04-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms
Product
GSK3377794
Collaborators
Not applicable
Study date(s)
December 2021 to October 2022
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
10+ years
Accepts healthy volunteers
No
- 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])
- Any prior treatment with oncology cell and/or gene therapy (unless agreed in advance with Sponsor)
- Prior malignancy not in complete remission.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Waterloo, Iowa, United States, 50701
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Springfield, Missouri, United States, 65807
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Gainesville, Florida, United States, 32608
Status
Terminated/Withdrawn
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Other
Actual primary completion date
2022-04-10
Actual study completion date
2022-04-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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