Trial Outcomes & Findings for Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials (NCT NCT05100316)
NCT ID: NCT05100316
Last Updated: 2024-02-05
Results Overview
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.
TERMINATED
PHASE2
16 participants
Up to 2 weeks
2024-02-05
Participant Flow
This screening study was intended to determine potential eligibility of participants for GlaxoSmithKline's Adoptive T-cell therapy studies by screening for appropriate biomarkers. The study was terminated early due to feasibility reasons.
A total of 16 participants were enrolled in the study and provided blood sample for biomarker assessment.
Participant milestones
| Measure |
Participants With Non-small Cell Lung Cancer (NSCLC)
Participants with NSCLC were screened for appropriate biomarkers for an intended adoptive cell therapy on a separate treatment trial. No study treatment was administered in this study.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials
Baseline characteristics by cohort
| Measure |
Participants With Non-small Cell Lung Cancer (NSCLC)
n=16 Participants
Participants with NSCLC were screened for appropriate biomarkers for an intended adoptive cell therapy on a separate treatment trial. No study treatment was administered in this study.
|
|---|---|
|
Age, Continuous
|
63.8 Years
STANDARD_DEVIATION 7.49 • n=39 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
ASIAN - JAPANESE HERITAGE
|
1 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
2 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
WHITE-WHITE/CAUCASIAN/EUROPEAN HERITAGE
|
13 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeksPopulation: Enrolled population included all participants who provided sample for biomarker assessment.
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.
Outcome measures
| Measure |
Participants With Non-small Cell Lung Cancer (NSCLC)
n=16 Participants
Participants with NSCLC were screened for appropriate biomarkers for an intended adoptive cell therapy on a separate treatment trial. No study treatment was administered in this study.
|
|---|---|
|
Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status
One HLA Allele Positive
|
9 Participants
|
|
Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status
Two HLA Allele Positive
|
1 Participants
|
|
Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status
Negative
|
6 Participants
|
|
Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status
Ambiguous
|
0 Participants
|
Adverse Events
Participants With Non-small Cell Lung Cancer (NSCLC)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER