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CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

ClinicalTrials.gov Identifier
NCT04660929
Institution Name
University of Pennsylvania Abramson Cancer Center
Full Institution Address





United States
Institution Phone
(215) 220-9678
Institution Website
https://www.clinicaltrials.gov/ct2/show/NCT04660929?term=0508&draw=1&rank=1
Additional Institutions
University of North Carolina Lineberger Comprehensive Cancer Center
919-445-4208
catherine_cheng@med.unc.edu
Spencer.laing@med.unc.edu
Study Overview
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 Information
Active, aiming for 18 treated and evaluable patients
Study Start Date
20201218
Study End Date
20241231
Study Purpose

  • 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

  • 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

  • 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 Study

  • Cardiac evaluation (echocardiogram)

  • Tumor biopsy showing positivity for HER2

  • CT scans to measure tumors before and after treatment
Potential Side Effects

  • 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).
Financial Assistance Available
No