NeoplasmsPhase 2NCT05100316

Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials

A Phase 2 study testing Screening Platform in people with Neoplasms, run by GlaxoSmithKline at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 10 years and older
Conditions the study is for: Neoplasms
What is being tested?: Screening Platform
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 3 sitesUnited States
Study dates: 16 Dec 2021to 4 Oct 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

3 sites in 1 country.

United States3 sites

GSK Investigational Site
Gainesville, Florida, 32608
GSK Investigational Site
Springfield, Missouri, 65807
GSK Investigational Site
Waterloo, Iowa, 50701

Other trials in United States

About this study

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

Conditions: Neoplasms
Being tested: Screening Platform
Keywords: Adoptive T-cell therapy, Hematologic Malignancy, Human leukocyte antigen, Screening study, Solid Tumors, T-cell receptors
Medical subject headings: Neoplasms, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Screening PlatformOther
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.

Study groups in NCT05100316
Study group	Role	What they receive
Participants with solid tumors and hematological malignancies	Other	Participants with solid tumors and hematological malignancies will be included. No study treatment will be administered in this study. Receives: Other: Screening Platform

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status
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.
Measured: Up to 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 20214 Oct 2022

First posted29 Oct 2021
Study start16 Dec 2021
Primary completion4 Oct 2022
Study completion4 Oct 2022

Why it stopped: Trial terminated due to feasibility reasons

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NeoplasmsStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05100316
Sponsor's protocol ID: 213033
Status last verified: May 2023
First submitted: 18 Oct 2021
Last updated: 5 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05100316
Acronym / sponsor ID: 213033
Conditions: Neoplasms
Keywords: Adoptive T-cell therapy, Hematologic Malignancy, Human leukocyte antigen, Screening study, Solid Tumors, T-cell receptors
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Trial terminated due to feasibility reasons
Enrolment: 16 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 16 Dec 2021 (actual)
Primary completion: 4 Oct 2022 (actual)
Study completion: 4 Oct 2022 (actual)
First posted: 29 Oct 2021 (actual)
Results: Posted 5 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Participants with solid tumors and hematological malignancies	Other	Other: Screening PlatformParticipants with solid tumors and hematological malignancies will be included. No study treatment will be administered in this study.

Who may qualify

Ages: 10 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Screening PlatformEligible 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.	Other	Participants with solid tumors and hematological malignancies

Primary outcome

Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status
Time frame: 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.

Results and safety

Results posted to the registry on 5 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With Non-small Cell Lung Cancer (NSCLC)	16	16

Primary outcome: Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status

Time frame: Up to 2 weeks. Count of participants. Unit: Participants

Measure	Participants With Non-small Cell Lung Cancer (NSCLC) n = 16
One HLA Allele Positive	9
Two HLA Allele Positive	1
Negative	6
Ambiguous	0

Population analysed: Enrolled population included all participants who provided sample for biomarker assessment.

Adverse events

Time frame: All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 2 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants With Non-small Cell Lung Cancer (NSCLC)	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

Related trials for Neoplasms

Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
Not yet recruitingPhase 2
A Phase II Clinical Study Evaluating the Efficacy and Safety of SXRN Injection in Patients With Cancer Cachexia
Cachexia-Anorexia Syndrome, Cachexia; Cancer
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Screening Platform in people with Neoplasms, run by GlaxoSmithKline at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05100316.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.