Breast Cancer Clinical Trial

CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

Summary

Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.

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Full 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 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

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Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

48

Study ID:

NCT04660929

Recruitment Status:

Active, not recruiting

Sponsor:

Carisma Therapeutics Inc

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There are 7 Locations for this study

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City of Hope National Medical Center
Duarte California, 91010, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States
OHSU Knight Cancer Institute
Portland Oregon, 97239, United States
Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States
Tennessee Oncology / Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
M D Anderson Cancer Center
Houston Texas, 77030, United States
Fred Hutchinson Cancer Center
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

48

Study ID:

NCT04660929

Recruitment Status:

Active, not recruiting

Sponsor:


Carisma Therapeutics Inc

How clear is this clinincal trial information?

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