Status:
ACTIVE_NOT_RECRUITING
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
Lead Sponsor:
Carisma Therapeutics Inc
Conditions:
HER2-positive
Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.
Detailed Description
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 S...
Eligibility Criteria
Inclusion
- 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
- 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:
Key Trial Info
Start Date :
February 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04660929
Start Date
February 2 2021
End Date
December 31 2024
Last Update
December 18 2024
Active Locations (7)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
3
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
4
Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104