NCT05127824

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Jodi Maranchie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants with newly diagnosed, non-metastatic, histologically confirmed, clear cell renal cell carcinoma (ccRCC) who have elected to undergo surgical resection, will receive neoadjuvant autologous Tumor Blood Vessel Antigen (TBVA)-Dendritic Cell Vaccine intradermally every 2 weeks x 2 (days 7(+/-3) and 21(+/-3)) prior to surgery on day 31(+7) with oral cabozantinib 20 mg daily for 10 days. We hypothesize that treated renal tumors will demonstrate maturation and organization of the tumor endothelium with normalization of endothelial markers and formation of tertiary lymphoid structure capable of promoting specific T-cell induction.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
BIOLOGICAL	Autologous 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.
DRUG	Cabozantinib	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.

Timeline

• Start date: 2023-07-06
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2021-11-19
• Last updated: 2025-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study