Breast Cancer Clinical Trial
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.
A Phase 1, First in Human Study of Adenovirally Transduced Autologous Macrophages Engineered to Contain an Anti-HER2 Chimeric Antigen Receptor in Subjects with HER2 Overexpressing Solid Tumors
Main Study - Group 1 and Group 2 all HER2 overexpressing solid tumors
Intraperitoneal Substudy - HER2 overexpressing peritoneal disease
89[Zr] radiolabeled CT-0508 Substudy - All HER2 overexpressing solid tumors (Univ of Penn, Abramson Cancer Center only)
CT-0508 Combination with Pembrolizumab Substudy - All HER2 overexpressing solid tumors
HER2-positive recurrent or metastatic solid tumors for which there are no available curative treatment options.
Breast cancer and gastric/gastroesophageal junction cancers must have failed approved HER2-targeted agents.
Other HER2-positive tumor types must have failed standard of care therapies, while prior therapy with anti-HER2 drugs is not required.
Subject must be willing and able to undergo tumor tissue biopsy procedures
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Subject has adequate bone marrow and organ function
HIV, active hepatitis B or hepatitis C infection.
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.
o Subjects with small, asymptomatic CNS metastases that do not require treatment are permitted to enroll.
Left ventricular ejection fraction (LVEF) <50% as determined by ECHO or multiple gated acquisition scan (MUGA)
Other protocol-defined Inclusion/Exclusion may apply.
CT-0508 in Combination with Pembrolizumab Substudy Only:
Subjects with severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Subjects with an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
Subjects who have a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Subjects who have had an allogeneic tissue/solid organ transplant
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There are 7 Locations for this study
Duarte California, 91010, United States More Info
Chapel Hill North Carolina, 27599, United States More Info
Portland Oregon, 97239, United States More Info
Philadelphia Pennsylvania, 19104, United States More Info
Nashville Tennessee, 37203, United States More Info
Houston Texas, 77030, United States More Info
Seattle Washington, 98109, United States More Info
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