Phase 1 Mesothelioma 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:

• People who have mesothelioma (a specific type of cancer) that cannot be surgically removed, has spread, or has come back, or who have other solid tumour cancers that produce a protein called mesothelin. For mesothelioma, only certain tumour types (epithelioid or mostly epithelioid) are eligible.
• People whose cancer has continued to grow or spread after receiving at least one standard cancer treatment that has been approved by the FDA for their cancer type.
• People who have at least one tumour that can be measured on a scan using standard criteria.
• People whose tumour tissue — from either a new biopsy or a stored sample — shows a sufficient level of the mesothelin protein (rated 2+ or 3+ in at least half of cancer cells) when tested in the laboratory.
• People aged 18 or older.
• People who are in reasonably good general health, able to carry out normal daily activities with minimal limitations (this is measured using a standard scale called ECOG, scored 0 or 1).
• People whose blood counts, liver function, kidney function, and blood clotting results are within acceptable ranges as determined by blood tests.
• People whose heart is pumping well enough (at least 45% ejection fraction on a heart scan) with no significant fluid build-up around the heart.
• People whose blood oxygen level is 90% or above while breathing normal room air.
• People whose side effects from previous cancer treatments have mostly settled (reduced to a mild level or lower).
• People who have cancer that has spread to the brain, as long as they have no symptoms, have completed treatment for the brain disease, have had stable brain scans for at least three months, and have stopped taking steroid or anti-seizure medications for those brain metastases at least four weeks before entering the study.
• People who are able to have children or father children and agree to use highly effective contraception or abstain from sex during and after the study as required.
• People who are breastfeeding and agree to stop breastfeeding for the required period during and after treatment.
• People who are able to understand the study and are willing to sign a consent form.

Who may not be able to join:

• People who have received any systemic cancer treatment, an experimental therapy, radiation, or surgery within 14 days before a blood cell collection procedure (leukapheresis), or within 21 days before the chemotherapy used to prepare the body for the treatment.
• People who have received certain immune checkpoint drugs (anti-PD-1 or anti-PD-L1 antibodies) or similar immune-stimulating treatments within 8 weeks before the start of treatment.
• People who have any form of primary immune deficiency disorder (such as severe combined immunodeficiency).
• People who have or have had certain autoimmune or immune-related diseases, such as multiple sclerosis, lupus, inflammatory bowel disease, rheumatoid arthritis, or small vessel vasculitis. (Note: conditions such as vitiligo or thyroid disorders managed with hormone replacement may still be eligible — confirm with trial site.)
• People who have had a severe allergic reaction to either of the chemotherapy drugs used in this trial (cyclophosphamide or fludarabine).
• People who have been taking high-dose steroid medications within 14 days before the start of treatment. Very low daily doses and topical steroids (creams, ointments, eye drops) are generally permitted.
• People who have lung scarring, inflammatory lung disease, or signs of lung inflammation on scans or in their medical history.
• People who have or have had another cancer, with some specific exceptions (such as certain treated skin cancers, early-stage cancers with no recurrence, or cancers fully removed and in remission for five or more years — confirm with trial site for details).
• People whose heart electrical reading (ECG) shows an abnormal result above certain thresholds.
• People who have an active infection with HIV, Hepatitis B, Hepatitis C, or HTLV as determined by specific blood tests.
• People who are pregnant or plan to become pregnant during the required contraception period.
• People who have received a live or weakened vaccine within 30 days before the start of treatment.
• People who have a history of seizure disorders, unless the seizures were caused by brain metastases that have since been treated.
• People who have another ongoing serious illness or active infection that could affect their safety or ability to participate in the study.

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