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Clinical Trials Unit
The Clinical Trials Unit (CTU) operates under the auspices of the Center for Cellular Immunotherapies (CCI), and under the direction and leadership of its Administrative Director, Lester Lledo, DNP, RN, CRNP. The CTU team supports the CCI’s translation and advancement of novel, first-in-human investigational cancer therapeutic discoveries to the bedside through its contribution of logistical strategies for trial implementation. CTU leadership creates efficient work and staffing models to meet the CCI clinical research program mission and objectives. The CTU team members use their vast experience and knowledge in conducting cell therapy trials to create innovative, effective and sustainable clinical research workflows which integrate seamlessly into established outpatient and inpatient clinical workflows. This ensures a high-quality patient care delivery system and continuity of care for our trial participants, while optimizing the output of our CCI managed clinical trials at the University of Pennsylvania.
The CTU is comprised of experienced, well-educated and trained clinical research managers, research nurses, research coordinators and regulatory specialists whose combined expertise shifts the paradigm for the standards for conducting cancer trials. These individuals have become the go-to veterans in clinical research nursing, coordination, and consulting for other groups venturing into their first CAR-T therapy trials.
Patient 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.
Clinical Trials Unit Members:
- Lester Lledo, DNP, RN, CRNP – Director, Clinical Research Operations
- Joan Gilmore, BS, CCRP - Associate Director, Clinical Research Operations
- Karen Dengel, BSN, RN – Clinical Research Manager
- Jane Anderson, MS, CCRC – Sr. Regulatory Specialist and Manager
- Aliza Schmidt, MS, MBE – Project Manager
- Reenie Martins, BA – Clinical Project Manager
- Joanne Shea, BSN, MSHA, RN – Clinical Research Nurse
- Kim-Marie Shea, BSN, RN – Clinical Research Nurse
- Michael Moniak, BSN, RN – Clinical Research Nurse
- Yan Jiang, MSN, RN – Clinical Research Nurse
- Charles Tongue, BSN, RN – Clinical Research Nurse
- Michelle Caylor, BS – Clinical Research Coordinator
- Lee Dengel – Clinical Research Coordinator
- Megan O’Brien – Clinical Research Coordinator
- Amanda Cervini, BS, BSN – Clinical Research Coordinator
- Jeanne McConville, BS – Clinical Research Coordinator
- Anthony Perez, BS – Clinical Research Coordinator
- Nicolas Sarmiento, BA – Clinical Research Coordinator
- Alexis Upshur, BA – Clinical Research Coordinator
- Shereese Richardson, BS – Regulatory Coordinator
- Rutendo Manyeka, MS – Trial Sample Coordinator
Research Personnel:
- Clinical Research Nurses and Clinical Research Coordinators – clinical research personnel who support conduct of and coordinate study subject participation in our clinical trials, safety reporting, complete data collection and real-time data entry, data discrepancy reconciliation to ensure accurate and high-quality data outputs are used to analyze and evaluate study outcomes.
- Regulatory Coordinators – personnel who complete submission of the protocol and all related study documents to our internal/institutional regulatory committees (i.e., IRB) for review and approval and coordinate completion of all regulatory documents and correspondences that support the protocol review and approval, and overall execution of the trial at our study site.
Listing of CCI-CTU Managed Trials:
|
Title |
Protocol # |
Disease Indication |
Cell-Biologic Product |
Principal Investigator |
|
Phase 1 Study of Human Chimeric Antigen Receptor Modified T Cells in Patients with Pancreatic Cancer (NCT03323944) |
UPCC 14217 |
Pancreatic Cancer |
huCART-MESO Cells |
Janos Tanyi, MD, PhD |
|
Phase 1 Trial of Human Chimeric Antigen Receptor Modified T Cells (huCART-meso) Administered in Combination with VCN-01 in Patients with Pancreatic and Serous Epithelial Ovarian Cancer (NCT05057715) |
UPCC 03821 |
Ovarian & Pancreatic Cancers |
huCART-MESO Cells + VCN-01 |
Janos Tanyi, MD, PhD |
|
Phase 1 Trial of Human Chimeric Antigen Receptor Modified T Cells in Patients with Mesothelin Expressing Breast Cancer (NCT05623488) |
UPCC 15122 |
Triple Negative Breast Cancer |
huCART-MESO Cells |
Julia Tchou, MD, PhD |
|
Phase 1 Trial of huCART1-IL18 Cells in Patients with Relapsed or Refractory CD19+ Cancers (NCT04684563) |
UPCC 15420 |
NHL, CLL, ALL |
CART19-IL18 Cells |
Jakub Svoboda, MD |
|
Phase 1 Trial of TmCD19-IL18 CAR T Cells in Patients with Relapsed or Refractory CD19+ Cancers (NCT05989204) |
UPCC 12423 |
NHL |
CART19-IL18 Cells |
Jakub Svoboda, MD |
|
Phase 1 Trials of GFRα4 CAR T Cells in Adult Patients with Recurrent or Metastatic Medullary Thyroid Cancer (NCT04877613) |
UPCC 12320 |
Medullary Thyroid Cancer |
GFRα4 Cells |
Roger Cohen, MD |
|
Phase 1, Open-label Study Evaluating the Safety and Feasibility of CART-EGFR-IL13Rα2 Cells in Patients with EGFR-Amplified Recurrent Glioblastoma (NCT05168423) |
UPCC 16321 |
Glioblastoma |
CART-EGFR-IL13 Rα2 Cells |
Stephen Bagley, MD, MScE |
|
Phase 1 Study of Lentivirally Transduced T Cells Engineered to Contain Anti-CD38 Linked to TCRζ and 4-1BB Signaling Domains in Subjects with Acute Myeloid Leukemia and Multiple Myeloma (NCT05442580) |
UPCC 19422 |
Multiple Myeloma & AML |
Anti-CD38LV redirected T cells |
Edward Stadtmauer, MD |
|
Phase I, Open-Label Study of Dually Armored Chimeric Antigen Receptor (CAR) T cells (TmPSMA-02) in Patients with Metastatic Castrate-Resistant Prostate Cancer (mCRPC) (NCT 06046040) |
UPCC 11823 |
Prostate Cancer |
TmPSMA-02 CAR T cells |
Vivek Narayan, MD, MScE |
|
Phase 1 Trial of CART123 Cells Given in Combination with Ruxolitinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) (Pending Activation) |
UPCC 50424 |
AML |
Anti-CD123 LV redirected T cells |
Saar Gill, MD, PhD |
|
Pilot, Open-Label Study Evaluating the Safety and Feasibility of Using Rescue Therapies for CAR T cell Related Cytokine Release Syndrome (CRS) and HLH-like Syndrome NCT #05306080 |
UPCC 01422 |
Rescue Therapies for CAR T cell Related Cytokine Release Syndrome (CRS) and HLH-like Syndrome |
Tadekinig alfa |
David Porter, MD |