CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

Study Name
	CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
ClinicalTrials.gov Identifier (if applicable)
	NCT04660929
Clinical Trial Category (check all that apply)
	Beyond First Line Therapy Targeted Therapy Immunotherapy Other Novel Therapy
Study Center
Institution Name
	University of Pennsylvania Abramson Cancer Center
Institution Address
	krista.ciminera@pennmedicine.upenn.edu
Country
	United States
Phone
	(215) 220-9678
Website
	https://www.clinicaltrials.gov/ct2/show/NCT04660929?term=0508&draw=1&rank=1
List additional Institutions (include address, phone number, and website)
	University of North Carolina Lineberger Comprehensive Cancer Center 919-445-4208 catherine_cheng@med.unc.edu Spencer.laing@med.unc.edu
OVERVIEW – in layman’s terms (150 words max)
	This is a Phase 1 clinical trial using modified macrophages obtained via apheresis, given intravenously without preparative chemotherapy, for patients with advanced HER2 over expressing solid tumors including cholangiocarcinoma.
Enrollment
	Active, aiming for 18 treated and evaluable patients
Study Start Date
	12/18/2020
Estimated Completion Date
	12/31/2024
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	Describe the safety profile of intravenous administration of HER2 CAR-macrophages Manufacturing feasibility Correlative studies (biopsies and blood samples) to fully understand the mechanism of action and safety profile Efficacy – evaluate tumor measurements over time and time without progression of disease
Inclusion Criteria – Patients Must:
	Minimum 18 years old HER2-positive recurrent or metastatic solid tumors for which there are no available curative treatment options. Subject must be willing and able to undergo tumor tissue biopsy procedures
Exclusion Criteria – Patients Must NOT:
	Diagnosis of immunodeficiency or chronic exposure to systemic corticosteroid therapy or any other form of immunosuppressive therapy Untreated or symptomatic central nervous system (CNS) metastases or cytology proven carcinomatous meningitis. Other protocol-defined Inclusion/Exclusion may apply.
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
	Cardiac evaluation (echocardiogram) Tumor biopsy showing positivity for HER2 CT scans to measure tumors before and after treatment
POTENTIAL SIDE-EFFECTS – in layman’s terms
	Currently unknown, this is a “first in human” clinical trial. Potential side effects may include those of other cell therapies and those of other HER2 targeted agents (unlikely).