Clinical Trials Unit

The Clinical Trials Unit (CTU) operates under the auspices of the Center for Cellular Immunotherapies (CCI) Medical Affairs Department under the direction  of Dr. David Porter. As head of Medical Affairs, Dr. Porter engages with CCI as a thought leader in developing innovative cellular therapies, collaborates in trial design, provides medical expertise, weighs in on scientific merit of the trials, and identifies unmet medical needs and opportunities for pioneering new technologies. The CTU is under the direct management of its Administrative Director Lester Lledo, MSN, CRNP, who is responsible for management of programmatic operations pertaining to staffing, process workflow, standard operating procedures, compliance with federal regulations and institutional policies.  Directly reporting to Lester Lledo are his team of managers who are responsible for  oversight of the daily activities of the  research staff and their assigned projects.  The CTU is comprised of well educated and trained research personnel who carry-out a variety of responsibilities and functions directly related to the execution of the study protocols. Collectively this division of CCI seeks to shift the paradigm for the standards of clinical research in oncology.

Clinical Trials UnitPatient Care

  • Focus on safety and rights of human subjects participating in clinical trials. 
  • Facilitate continuity of medical care during study participation.

Clinical Research

  • Conduct of Exploratory-Pilot through Phase II first in human clinical trials. 
  • Support research and development of novel therapies targeting cancer. 

Regulatory Compliance

  • Ensure that clinical trials are conducted in compliance with all applicable federal regulations, ICH/GCP guidelines and institutional policies. 

Data Collection

  • Ensure accurate, complete and timely data collection and reconciliation of data discrepancies.