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

View Eligibility Criteria

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:

Recruiting

Sponsor:

Carisma Therapeutics Inc

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There are 7 Locations for this study

See Locations Near You

City of Hope National Medical Center
Duarte California, 91010, United States More Info
Joanne E Mortimer, MD
Contact
626-218-9200
[email protected]
UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States More Info
OHSU Knight Cancer Institute
Portland Oregon, 97239, United States More Info
Richard Maziarz, MD
Contact
503-494-1080
[email protected]
Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States More Info
Tennessee Oncology / Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
AskSarah
Contact
615-329-7274
Melissa Johnson, MD
Principal Investigator
M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Angela Alexander
Contact
713-792-9137
[email protected]
Fred Hutchinson Cancer Center
Seattle Washington, 98109, United States More Info
SCCA Intake
Contact
206-606-1024
[email protected]

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:

Recruiting

Sponsor:


Carisma Therapeutics Inc

How clear is this clinincal trial information?

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