RecruitingPhase 2NCT05127824

Autologous Dendritic Cell Vaccine in Kidney Cancer

A Phase 2a Study to Type I-Polarized Autologous Dendritic Cell Vaccines Incorporating Tumor Blood Vessel Antigen (TBVA)-Derived Peptides in Combination With Cabozantinib in Patients With Localized Clear Cell Renal Cancer.


Sponsor

Jodi Maranchie

Enrollment

42 participants

Start Date

Jul 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to estimate the probability of immune response for the combination treatment of dendritic cell vaccine with oral cabozantinib and characterize the safety profile of interventional therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a personalized cancer vaccine made from a patient's own immune cells (dendritic cells) in people with non-metastatic clear cell kidney cancer (renal cell carcinoma) who are having surgery to remove the tumor. After the kidney is removed, immune cells from the patient's blood are used to create a custom vaccine designed to train the immune system to recognize and attack any remaining cancer cells. **You may be eligible if...** - You are 18 or older with confirmed clear cell renal (kidney) cancer that has not spread - Your cancer can be surgically removed - You have a specific immune type (HLA-A2 positive) if receiving the vaccine - Your blood counts and organ function are adequate - Your ECOG performance status is 0 or 1 (fully active or mostly active) **You may NOT be eligible if...** - Your cancer has spread to other organs (metastatic) - You are not HLA-A2 positive (required for the vaccine group) - You have autoimmune disease or are on immunosuppressive drugs - You have had prior systemic therapy for kidney cancer - You have significant heart, liver, or kidney dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous alpha-DC1/TBVA vaccine

Dendritic cells (DC) are derived from autologous (the subject's own) mononuclear cells in the peripheral blood obtained from the PRBC. In this case, "biologic product" and "biologic substance" are the same. The vaccine will be manufactured in the HCC-IMPCL, under cGMP conditions.

DRUGCabozantinib

Cabozantinib tablets are supplied as film coated tablets containing cabozantinib malate equivalent to 20 mg and 60 mg of cabozantinib and contain microcrystalline cellulose, lactose anhydrous, hydoxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate and Opadry® yellow. The 60 mg tablets are oval and the 20 mg tablets are round. Doses of 40 mg will comprise two 20-mg tablets.


Locations(1)

UPMC Department of Urology

Pittsburgh, Pennsylvania, United States

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NCT05127824


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