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New treatment option for Alveolar Soft Part Sarcoma
Official title GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed/Refractory GPNMB-Expressing Solid Tumours
ClinicalTrials.gov ID: NCT07297667
What this study is testing
What is Fludarabine?
Fludarabine is an investigational medicine, being studied as a potential treatment for alveolar soft part sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 and older
You may be able to join if
- 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...
- 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)
You likely can't join if
- 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...
- Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the participant to be managed according to...
See the full eligibility criteria
Who can 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.
- 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...
- 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.
What rules you out
- 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...
- 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:
- 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...
- HIV positive by serology and PCR
- Uncontrolled fungal, bacterial, viral or other infection
- Current infection with HTLV-1
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.