Study Testing the Biologic Activity and Safety of an Immunotherapeutic in Patients With Newly Diagnosed Stage IV Kidney Cancer

Argos Therapeutics22 enrolled

Overview

The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of multiple administrations of dendritic cell Immunotherapeutic to patients with newly diagnosed with metastatic kidney cancer

In this study, a new Immunotherapeutic production process will be used that shows evidence of potentially much higher biologic activity in pre-clinical studies than the production process used in a previous study (clinical protocol MB-002-003). While both processes are based on individual subject autologous tumor RNA and autologous monocyte derived DCs, the maturation of DCs in this newly modified process involves an altered regimen of culture with cytokines. In addition, huCD40L mRNA is added to the autologous expanded tumor total mRNA for electroporation. These changes promise a much improved migration, and activity profile of the DC-Immunotherapeutic product in RCC subjects.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Cell Carcinoma

Interventions

AGS-003BIOLOGICAL

Dendritic cell, autologous cellular immunotherapy. (Arcelis platform)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have a new diagnosis of metastatic renal cell carcinoma; * Measurable disease * Must be at least 18 years or older; * Have a scheduled unilateral nephrectomy or excisional biopsy/metastasectomy * ECOG of 0 or 1; * Free of brain metastases by CT or MRI; * Normal renal function in contralateral kidney; * Male or non-pregnant/non-lactating female on appropriate birth control methods while on study; * Clinically acceptable screening results. * No immunosuppressive therapy not limited to corticosteroids (including topical steroids or steroid containing inhalers), azathioprine cyclosporine two months prior to study entry; * No active autoimmune disease

Locations (10)

UCLA Kidney Cancer Program

Los Angeles, California, United States

Univ. of Colorado Health Science Center - Division of Medical Oncology

Aurora, Colorado, United States

Emory University

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

1. Measure tumor response by RECIST as CR, PR, SD, PD. 2. Measure T-cell responses to vaccination using induction vaccination regimens.

Time frame: 24 weeks

Secondary Outcomes

Assess safety of multiple administrations of the Immunotherapeutic in subjects with newly diagnosed, metastatic Renal Cell Cancer Assess Overall Survival and Time to progression

Time frame: 24 weeks plus follow-up

Data from ClinicalTrials.gov

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