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
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||January 2021||Phase 1||Interventional|
Primary Outcome 1 - Measure: Assess the safety and tolerability of CT-0508 by estimating the frequency and severity of adverse events in subjects with HER2 overexpressing solid tumors.
Primary Outcome 1 - Time Frame: 14 months
Primary Outcome 2 - Measure: Assess the feasibility of manufacturing CT-0508 by describing the percentage of products passing release criteria.
Primary Outcome 2 - Time Frame: 12 months
- 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
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.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Debora Barton, MD
Role: Study Director
Affiliation: Carisma Therapeutics
Name: Chief Medical Officer
|UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
|Not yet recruiting||
|Abramson Cancer Center
Philadelphia, Pennsylvania 19104