Gene therapy trial for advanced kidney cancer halted early

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient aged between 18 - 70 years old * Women of childbearing potential must have a negative pregnancy test at screening and agree to use two distinct acceptable methods of contraception (which may include partner contraception) for the duration of the study * Men with partners of childbearing potential must be willing to use acceptable barrier contraceptive method during the trial or have undergone a vasectomy at least 6 months prior to study entry and confirmed by semen analysis * Adequate cardiac, renal, hepatic, pulmonary, and hematologic function * Patient able and willing to provide written informed consent and comply with study protocol and procedures * Histologically confirmed diagnosis of unresectable, locally advanced/metastatic RCC with clear cell component, with or without sarcomatoid features * Presence of a disease burden sufficiently large to permit biopsy * Disease progression following approved standard of care treatments for metastatic disease * ECOG PS 0-1 * Measurable disease at physical examination or at imaging assessment according to RECIST 1.1 criteria Exclusion Criteria: * Use of investigational agents or procedures in the 4 weeks prior to study enrolment (6 weeks for long-acting agents) or receipt of an experimental gene therapy product in the past 2 years * History of current evidence of neuropsychiatric illness * History of severe cardiovascular disease * Evidence of haematological neoplasm * Active alcohol or substance abuse within 6 months of the study * Current pregnancy or lactation * Expected to undergo a surgical intervention during the first 3 months of the study * Known bleeding diathesis or history of abnormal/severe bleeding or any other known coagulation abnormalities that would contraindication a tissue biopsy, active treatment with anticoagulants. * New CNS or rapidly growing metastases or carcinomatous meningitis * Presence of hepatic metastases * Previous allogenic bone marrow, renal, liver transplant * Prior use of immunosuppressives in the previous 4 weeks prior to enrolment * Clinically relevant active viral, bacterial or fungal infection * Active autoimmune disease requiring disease modifying treatment.