Phase 1 Kidney Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The tumour tissue sample must test positive for a protein called GPNMB at high levels, confirmed by a central laboratory using a specific staining test.
• People must have a confirmed diagnosis of one of these cancer types that is advanced, has spread, come back, or cannot be surgically removed, and for which no curative treatment exists: alveolar soft part sarcoma (ASPS), non-clear cell renal cell carcinoma (a type of kidney cancer), or triple negative breast cancer (a type of breast cancer that lacks three specific receptors).
• A preserved tumour tissue sample (from either the original or a spread tumour) must be available and consent for its release must be provided.
• Disease must be visible and measurable on imaging scans, according to a standard measurement system called RECIST 1.1.
• People with ASPS must be 15 years of age or older; people with triple negative breast cancer or kidney cancer must be 18 years of age or older.
• People must have a good general level of physical functioning, as measured by standard medical scales (ECOG 0 or 1, or Karnofsky/Lansky score above 60) (confirm with trial site).
• A life expectancy of at least 6 months is required.
• Prior treatment requirements vary by cancer type: people with ASPS must have completed all available survival-improving treatments unless those were not suitable; people with triple negative breast cancer must have received at least one prior treatment for metastatic disease including a specific antibody-drug therapy and, if the tumour expresses a marker called PD-L1, also an immunotherapy — with no more than three prior lines of metastatic treatment, and at least one prior chemotherapy regimen including both an anthracycline and a taxane (unless not suitable); people with kidney cancer must have had at least one prior treatment including both an immunotherapy and a targeted therapy, unless those were not suitable.
• Side effects from previous treatments must have largely resolved to a mild level or better.
• Appropriate time gaps since previous treatments, surgery (at least 21 days), or radiation therapy (at least 28 days) must have passed before joining the trial.
• Blood counts and organ function must meet the required levels.
• Signed consent (and assent where applicable, such as for younger participants) from the person or their parent or legal guardian is required before screening.
• People must be physically suitable for a procedure called leukapheresis (a process to collect immune cells from the blood) and have adequate vein access for this.
• People must be able to attend the participating centre for treatment and follow-up for at least 12 months, or longer if the treating doctor considers it necessary.
• People who could become pregnant must have agreed to use a highly effective method of contraception.

Who may not be able to join:

• People currently receiving active cancer treatment for another advanced or metastatic cancer.
• People receiving any other anti-cancer treatment at the same time.
• People who have previously received a gene therapy product, any adoptive T cell therapy (a type of immune cell treatment), or any therapy that targeted the GPNMB protein.
• People who have received a live vaccine within 30 days before the trial therapy, or who plan to receive one within 30 days after.
• People with a primary immune deficiency, or a history of severe autoimmune disease (such as Crohn's disease, rheumatoid arthritis, or lupus) that required immune-suppressing or disease-modifying medications within the past 2 years.
• People with active or uncontrolled infections, or serious medical conditions that would prevent safe participation, including: active hepatitis B or C (though people previously infected who are currently being treated and have undetectable virus levels may still be considered); HIV infection; uncontrolled fungal, bacterial, viral or other infections; HTLV-1 infection; tuberculosis; syphilis; or West Nile Virus.
• People with uncontrolled heart conditions or significant heart problems, including certain heart rhythm problems requiring medication, specific types of heart conduction defects, unstable chest pain, heart failure, or a heart attack within the past year.
• People with a known allergy or sensitivity to the drugs fludarabine or cyclophosphamide, or to the trial treatment GCAR1 or any of its components.
• People with active brain metastases or cancer spread to the lining of the brain or spinal cord — though people who have received definitive treatment for brain metastases, are medically stable, and no longer need corticosteroid medications may still be considered.
• People who are pregnant or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.