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

Principal Investigator

Richard Maziarz

Study Purpose

The purpose of this study is to test the safety of a study product called CT-0508.

The study product is made from monocyte cells, which are normally found in the blood and in many body tissues. Participants in this study will have monocyte cells collected, which will be transformed into macrophages. Macrophages are one type of immune cell that helps protect people from infections and also can help the immune system guard against cancer. However, once a cancer starts to grow and spread, the macrophages and other cells in the immune system may not be powerful enough to attack all the tumor cells. Researchers have found a way to put new genetic material (genes, or DNA) into macrophages which may help them to recognize a specific protein that is found in high levels on a cancer cell.

The study product is made to recognize the HER2 protein, which can be seen in high levels in some types of cancer.

One purpose of this study is to see if the study product can be made and then safely given back to participants with HER2-positive cancers. A second purpose is to see if the study product causes the tumors to shrink.

Medical Condition(s)

HER2-positive cancers
Breast Cancer
Ovarian Cancer
Non-Small Cell Lung Cancer
Colon Cancer

Eligibility Criteria

- 18 years of age or older
- HER2-positive cancer that has spread or come back after previous treatment and for which there is no available curative treatment
- Adequate heart function

- Pregnant or breastfeeding
- Known HIV infection or active hepatitis B or C
- Cancer in the nervous system that is either untreated or is causing symptoms

Age Range

18 - 120

Healthy Volunteers Needed


Duration of Participation

52 weeks

Minors Included



Clinical Trials Information Line


Carisma Therapeutics

Recruitment End


Compensation Provided


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