Condition: Clear Cell RCC

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06716853

Sponsor: Genenta Science

Phase: Phase 1/Phase 2

Eligibility:

• Age: minimum 18 Years maximum 70 Years
• Gender: All

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.

View trial on ClinicalTrials.gov