Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT02035358
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2014-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunotherapy Study for Metastatic Renal Cell Cancer
Sponsor:
NewLink Genetics Corporation
Organization:
Study Overview
Official Title:
A Phase I Study of HyperAcute-Renal (HAR) Immunotherapy In Patients With Metastatic Renal Cell Cancer
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this Phase 1 Trial investigators plan to establish the MTD of HyperAcute®-Renal (HAR) immunotherapy in subjects with clinically metastatic renal cell carcinoma.
Detailed Description:
Unfortunately, despite the best clinical efforts with surgical intervention and chemotherapy many patients with high grade and advanced stage renal cell carcinoma (RCC) progress and die of their disease. In United States approximately 13,000 individuals die from RCC each year. The primary cause of failure is microscopic spread of the tumor prior to complete surgical extirpation of detectable disease and the heterogenous nature of the metastatic cells. These cells are resistant to all forms of therapy including chemotherapy, radiation, and escape from immune surveillance by a variety of mechanism. This results in low 5-year survival rates (approximately 10%) in patients with metastasis. Novel immunotherapeutic strategies provide a hope in circumventing the drug resistant RCC and improve the survival of patients undergoing surgery. RCC, like melanoma is one of the most immunogenic tumors and partial successes have been achieved by a variety of immunotherapeutic strategies show partial successes. Although vaccines have been highlighted in clinical trials since the mid-1970s with subcutaneous autologous irradiated tumor cells most of these studies were in patients with advanced disease. These approaches resulted in rare if any clinically relevant benefits to patients. However, new vaccines in other cancers have shown responses equivalent to chemotherapy with minimal toxicity \[1\]. The use of immune adjuvant strategies to increase the therapeutic immune responses to tumor vaccines enhanced the proportion of patients with therapeutic responses to vaccination to 10%-15% on average. Only during the last decade has it become clear that failure of immune system to respond to the tumor vaccine is the main obstacle that limits the efficacy of vaccine based immunotherapies. The precise reason for failure of the immune system in cancers is very complex particularly as it relates to (1) the escape of growing or metastasizing tumor from immune surveillance \[2-4\] and (2) low immunogenicity of autoantigens associated with malignant neoplasms. This human clinical trial will investigate the dose limiting toxicity of a polyvalent immune enhanced vaccine as a first step towards developing a multipronged approach to triggering the immune system to attack and destroy micrometastatic disease. Investigators hypothesize that the allogeneic RCC cell genetically modified to express α (1,3)galactosyltransferase (enzyme responsible for producing the strong xenoantigen on the cell surface of the cellular immunotherapy) will augment the efficacy of cellular immunotherapy and thereby improve patient outcomes. In this Phase 1 Trial investigators plan to establish the maximum tolerated dose (MTD) of Hyperacute®-Renal (HAR) immunotherapy in subjects with clinically metastatic renal cell carcinoma.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: