CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

Inclusion Criteria

• 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

Exclusion Criteria

• 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: Exclusion Criteria:
• 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