Upstate Active Clinical Trials

Study Title:

A Phase 2b Randomized Trial of Autologous Dendritic Cell Immunotherapy (CMN-001) Plus Standard Treatment of Advanced Renal Cell Carcinoma

What is the purpose of the study? (in Layman's terms, please describe the study)

CoImmune is conducting a research study of an experimental (investigational) drug CMN-001 to see if it is effective against kidney cancer when combined with standard treatment. An investigational drug is a medication that is still being studied and has not been approved for use in the general population by the United States Food and Drug Administration (FDA). CMN-001 is made for you by using a piece of tumor collected after surgical removal of your kidney along with a certain type of your own white blood cells. The resulting product is a type of immune cell called a dendritic cell, which is very good at activating the immune system against cancer cells. CMN-001 can be used in combination with the approved, standard medications often prescribed for the treatment of kidney cancer. In this study, one group of study participants will receive standard medications for kidney cancer and a second group of study participants will receive standard medications for kidney cancer plus CMN-001. An important purpose of this study is to see if treatment with CMN-001 plus standard medications is any different than treatment with standard medications alone.

Upstate Institutional Review Board (IRB) Number:

1729053

Study/Protocol ID:

CMN-001-1

Study Phase:

IIb

Patient Age Group:

Adults

Principal Investigator:

Gennady Bratslavsky, MD

What is involved if I participate?

• How long is the study?
  Treatment will last until disease progression, unacceptable toxicity or subject withdrawal.
• Is transportation provided or reimbursed?
  No
• Is parking provided or reimbursed?
  No
• What tests and procedures are involved?
  Physical exams, blood work, urinalysis, pregnancy test-if applicable, CT scans, ECGs, Echocardiograms

Where will the study take place?

Upstate Cancer Center, Upstate University Hospital, Urology clinic

ClinicalTrials.Gov ID:

NCT04203901

For more information about this trial go to ClinicalTrials.Gov

Who can I contact for more information?

Name: Nicholas Carusone, BS
Phone: 315-464-5296
Email: carusonn@healthydairyland.com

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