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Alveolar Soft Part SarcomaPhase 1NCT07297667

GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed/Refractory GPNMB-Expressing Solid Tumours

A Phase 1 study testing Fludarabine, Cyclophosphamide and GCAR1 in people with Alveolar Soft Part Sarcoma and Renal Cell Carcinoma, run by Canadian Cancer Trials Group at 4 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Only enrolling in Canada. The purpose of this study is to identify the highest dose of GCAR1, a chimeric antigen receptor (CAR-T) cell therapy, that can be tolerated without causing very severe side effects, and to see what effects GCAR1 has on selected cancers Read more about this study

Who is it for?
Ages 15 years and older
What is being tested?
Fludarabine, Cyclophosphamide and GCAR1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
4 sitesCanada
Study dates
30 Aug 2026to 1 Sep 2033
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Archival tumour specimen must be positive for GPNMB with high expression by immunohistochemistry (central laboratory testing).
  • Histologically and/or cytologically confirmed diagnosis of one of the following tumours that is advanced/ metastatic/ recurrent or unresectable, for which no curative therapy exists.
  • alveolar soft part sarcoma
  • renal cell carcinoma (excluding clear cell)
  • triple negative breast cancer (ER, PR and HER-2 negative as defined by ASCO/CAP criteria)
  • Must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block.
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  • Presence of radiologically documented disease.
  • Measurable disease as defined by RECIST 1.1.
  • ASPS participants ≥ 15 years of age.
  • TNBC and RCC participants ≥ 18 years of age.
  • ECOG performance status of 0 or 1 or Karnofsky or Lansky > 60.
  • Anticipated life expectancy of ≥ 6 months.
  • Must have received prior systemic therapy as shown below;
  • ASPS - completed all systemic therapy available that has been shown to improve survival (unless contraindicated).
  • TNBC
  • Progressive disease following at least one line of systemic treatment for metastatic disease which must include an ADC (all participants) and an ICI (participants whose tumours express PD-L1).
  • ≤3 lines of treatment for metastatic disease.
  • Must have had at least 1 prior line of cytotoxic chemotherapy for breast cancer, in any setting, which must have included an anthracycline and a taxane (unless contraindicated).
  • RCC - must have progressive disease following at least one line of systemic treatment for metastatic disease that must have included an ICI and a VEGFR targeted agent (unless contraindicated).
  • Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior therapies.
  • Adequate washout must be followed per protocol.
  • Previous major surgery is permitted ≥21 days prior to enrollment
  • Prior external beam radiation is permitted ≥28 prior to enrollment. Concurrent radiotherapy is not permitted.
  • Adequate hematologic and biochemical parameters.
  • Consent and assent, when applicable, must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant or their parent/ legal guardian (if applicable) must sign a consent form prior to screening onto the trial to document their willingness to participate.
  • Fit for leukapheresis and has adequate venous access for cell collection.
  • Must be accessible for treatment and follow up at the participating centre for a minimum of 12 months or for as long as is deemed necessary by the treating physician.
  • Participants of childbearing potential must have agreed to use a highly effective contraceptive method.

Who cannot join

  • Participants on active anticancer therapy for other advanced or metastatic malignancies.
  • Concurrent treatment with other anti-cancer therapy
  • Prior therapy with a gene therapy product or any adoptive T cell therapy or prior GPNMB targeting therapy.
  • Live attenuated vaccination administered within 30 days prior to or planned within 30 days after GCAR1 therapy.
  • Primary immunodeficiency or history of severe autoimmune disease (including: Crohn's disease, rheumatoid arthritis, systemic lupus) requiring immunosuppressive agents/ systemic disease modifying agents within 2 years of enrollment.
  • Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the participant to be managed according to the protocol including but not limited to:
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  • Hepatitis B or C virus (HBV or HCV). For participants with previous HBV or HCV infection who are currently on treatment, they are eligible if they have an undetectable viral load via quantitative PCR and/or nucleic acid testing
  • HIV
  • Uncontrolled fungal, bacterial, viral or other infection
  • Current infection with HTLV
  • Tuberculosis
  • Syphilis
  • West Nile Virus
  • Untreated and/or uncontrolled cardiovascular conditions and/or symptomatic cardiac dysfunction (including cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects) or unstable angina congestive heart failure or myocardial infarction within the previous year.
  • Known sensitivity or allergy to fludarabine, cyclophosphamide or any of their components, or to GCAR1 or any of its components.
  • Active intracerebral metastases or leptomeningeal disease. Participants who have received definitive treatment, are clinically stable and do not require corticosteroids are eligible to participate in the trial.
  • Pregnant or breastfeeding women.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Laura Pearce contact

613-533-6430

lpearce@ctg.queensu.ca

Mariam Jafri contact

613-533-6430

mjafri@ctg.queensu.ca

Canada4 sites, 4 recruiting

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

    Mona Shafey, 403 944-8047

    Recruiting

  • The Research Institute of the McGill University

    Montreal, Quebec, H4A 3J1

    Ramy Saleh

    Not yet recruiting

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

    Natasha Kekre, 613 737-8899 ext. 71064

    Recruiting

  • University Health Network

    Toronto, Ontario, M5G 2M9

    Abdulazeez Salawu, 416 946-4501

    Recruiting

Other trials in Canada

About this study

Official title: A Phase I Study of GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Participants With Selected Relapsed/Refractory GPNMB-Expressing Solid Tumours

Only enrolling in Canada.

The purpose of this study is to identify the highest dose of GCAR1, a chimeric antigen receptor (CAR-T) cell therapy, that can be tolerated without causing very severe side effects, and to see what effects GCAR1 has on selected cancers

Read the detailed description

GCAR1 is a type of CAR-T cell therapy that is designed to identify a protein (GPNMB) that is present on the cells of certain types of cancer. Laboratory tests have shown that GCAR1 helps the immune system recognize cancer cells and may help slow down cancer growth.

The purpose of this study is to find out what effects the new treatment, GCAR1 has on certain cancers. This study will test increasing doses of GCAR1 in participants with alveolar soft part sarcoma (ASPS), triple negative breast cancer (TNBC), and renal cell carcinoma (RCC) expressing high levels of the GPNMB protein, to establish recommended doses for further testing.

Being tested
Fludarabine, Cyclophosphamide, GCAR1
Medical subject headings
Sarcoma, Alveolar Soft Part, Carcinoma, Renal Cell, Triple Negative Breast Neoplasms

What participants receive

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

Study groups in NCT07297667
Study groupRoleWhat they receive
GCAR1 InfusionExperimentalNot described
Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: GCAR1

What is being measured

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

  1. To determine the recommended phase II dose (RP2D), defined as the next lower dose below the maximum administered dose, of GPNMB directed CAR T cell therapy

    (GCAR1) in participants with selected tumours (alveolar soft part sarcoma, renal cell carcinoma (excluding clear cell), triple negative breast cancer) expressing GPNMB

    Measured: 3 years

Secondary outcomes (3)

  1. Number and severity of adverse eventsGCAR1 utilizing CTCAE v5.0

    Measured: 3 years

  2. Overall response rate utilizing RECIST 1.1

    Measured: 3 years

  3. Duration of response

    Measured: 3 years

Timeline

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

  1. First posted22 Dec 2025
  2. Study start30 Aug 2026
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Sep 2033 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07297667
Sponsor's protocol ID
I246
Status last verified
Oct 2026
First submitted
9 Dec 2025
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fludarabine, Cyclophosphamide and GCAR1 in people with Alveolar Soft Part Sarcoma and Renal Cell Carcinoma, run by Canadian Cancer Trials Group at 4 sites 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 28 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Laura Pearce (613-533-6430, lpearce@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the recommended phase II dose (RP2D), defined as the next lower dose below the maximum administered dose, of GPNMB directed CAR T cell therapy (time frame: 3 years). 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 NCT07297667.

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 16 Oct 2026.

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