Alveolar Soft Part SarcomaEarly Phase 1GCAR1NCT06827886
GPNMB-targeting Chimeric Antigen Receptor T-Cell Therapy (GCAR1) for a Patient With Alveolar Soft Part Sarcoma
A Early Phase 1 study testing GCAR1 in people with Alveolar Soft Part Sarcoma, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
CLIC-YYC-GPNMB-01 is a Single Patient Study (SPS) developed according to the Health Canada template and guidelines released in 2019 for studies to access therapies not otherwise available to patients, in the situation where there are no options of treatment or cure remaining. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Soft Part Sarcoma
- What is being tested?
- GCAR1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 6 Sep 2023to 9 Sep 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Completion of Informed Consent Form
Who cannot join
- 1. Any significant medical issue(s) that would, in the opinion of the Principal Investigator (PI), prevent this patient from being dosed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre
Calgary
About this study
Official title: GPNMB-targeting Chimeric Antigen Receptor T-Cell Therapy (GCAR1) for a Patient With Alveolar Soft Part Sarcoma (CLIC-YYC-GPNMB-01)
CLIC-YYC-GPNMB-01 is a Single Patient Study (SPS) developed according to the Health Canada template and guidelines released in 2019 for studies to access therapies not otherwise available to patients, in the situation where there are no options of treatment or cure remaining. The patient under consideration for CLIC-YYC-GPNMB-01 has progressive metastatic alveolar soft part sarcoma (ASPS). The investigators propose to treat the patient with GCAR1, a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB).
- Conditions
- Alveolar Soft Part Sarcoma
- Being tested
- GCAR1
- Medical subject headings
- Sarcoma, Alveolar Soft Part
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCAR1Biological
GCAR 1 is a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB).
| Study group | Role | What they receive |
|---|---|---|
| GCAR1 | Experimental | GCAR1, a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB) Receives: Biological: GCAR1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess safety of GCAR1
Treatment-Related Adverse Events to GCAR1 will be determined by monitoring participant for complications related to treatment using CTCAE v5.0.
Measured: 1 year
Assess for anti-tumor activity
To assess for anti-tumor activity by measuring response of specified lesions. Response will be assessed by RECIST 1.1. Progression free survival (PFS) is calculated as the period from the day of starting administration of the study drug to the date that disease progression is confirmed by radiographic assessment. Diagnostic imaging (CT and/or MRI) will be performed pre-infusion to document measurable disease, and 4-6 weeks after GCAR1 T-cell infusion to evaluate response to therapy. If diagnostic imaging studies are performed at other times, either during or after treatment on this study, that data will be collected and information gained may be used to for further direction in the study of anti-GPNMB CAR T-cells, if appropriate consent is obtained.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start6 Sep 2023
- Primary completion9 Sep 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Soft Part SarcomaStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Patient Study (SPS)
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mona Shafey, MD, FRCPC, Principal investigator, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827886
- Sponsor's protocol ID
- CLIC-YYC-GPNMB-01
- Acronym
- GCAR1
- Status last verified
- Jul 2025
- First submitted
- 3 Feb 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GPNMB-targeting Chimeric Antigen Receptor T-Cell Therapy (GCAR1) for a Patient With Alveolar Soft Part Sarcoma (CLIC-YYC-GPNMB-01)
- ClinicalTrials.gov ID
- NCT06827886
- Acronym / sponsor ID
- GCAR1 / CLIC-YYC-GPNMB-01
- Conditions
- Alveolar Soft Part Sarcoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CLIC-YYC-GPNMB-01 is a Single Patient Study (SPS) developed according to the Health Canada template and guidelines released in 2019 for studies to access therapies not otherwise available to patients, in the situation where there are no options of treatment or cure remaining. The patient under consideration for CLIC-YYC-GPNMB-01 has progressive metastatic alveolar soft part sarcoma (ASPS). The investigators propose to treat the patient with GCAR1, a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Patient Study (SPS)
| Arm | Type | Receives |
|---|---|---|
| GCAR1 | Experimental | Biological: GCAR1GCAR1, a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Completion of Informed Consent Form
Key exclusion criteria (1 listed)
- 1. Any significant medical issue(s) that would, in the opinion of the Principal Investigator (PI), prevent this patient from being dosed.
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 |
|---|---|---|
| GCAR1GCAR 1 is a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB). | Biological | GCAR1 |
Primary outcome
Assess safety of GCAR1
Time frame: 1 year
Treatment-Related Adverse Events to GCAR1 will be determined by monitoring participant for complications related to treatment using CTCAE v5.0.
Assess for anti-tumor activity
Time frame: 1 year
To assess for anti-tumor activity by measuring response of specified lesions. Response will be assessed by RECIST 1.1. Progression free survival (PFS) is calculated as the period from the day of starting administration of the study drug to the date that disease progression is confirmed by radiographic assessment. Diagnostic imaging (CT and/or MRI) will be performed pre-infusion to document measurable disease, and 4-6 weeks after GCAR1 T-cell infusion to evaluate response to therapy. If diagnostic imaging studies are performed at other times, either during or after treatment on this study, that data will be collected and information gained may be used to for further direction in the study of anti-GPNMB CAR T-cells, if appropriate consent is obtained.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Mona Shafey, MD, FRCPC principal investigator
Alberta Health services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing GCAR1 in people with Alveolar Soft Part Sarcoma, run by AHS Cancer Control Alberta at 1 site in Canada.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess safety of GCAR1 (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2025.