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.
Checked against the public recordLast updated Dec 18, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Carisma Therapeutics Inc
- Interventions being studied
- Biological: CT-0508; Biological: Pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- City of Hope National Medical CenterDuarte, California
- UNC Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina
- OHSU Knight Cancer InstitutePortland, Oregon
- Abramson Cancer CenterPhiladelphia, Pennsylvania
- Tennessee Oncology / Sarah Cannon Research InstituteNashville, Tennessee
- M D Anderson Cancer CenterHouston, Texas
- Fred Hutchinson Cancer CenterSeattle, Washington
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 18, 2024. Always confirm current availability with the study team.