Study Details

Open

HER2 Redirected Macrophages for Solid Tumors

The purpose of this study is to learn about the safety, effectiveness, and tolerability of an investigational product, CT-0508, for patients with advanced cancer. CT-0508 is a special kind of product that is made of blood cells taken from your own body. Once collected, your blood cells will be altered to create CT-0508 and infused back into your body. Investigators hope that the altered cells will be able to attack your tumor cells. This is part of the first study of this product in humans.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

United States (Nationwide)

What will be asked of you

Your participation in this study will last about 13 months and include up to 19 study visits to the study site. If you are one of the first 3 patients to enroll in this study, you will be asked to stay in the hospital for 8 days after your first infusion. Even if you are not one of the first 3 patients to enroll, there is a chance you may still be asked to stay in the hospital. There are 4 stages to this study: • The Screening Stage, where your health will be assessed to ensure you meet the requirements to participate in the trial; • The Pre-Dose Stage, where your body's blood cells will be collected and used to create CT-0508; • The Dosing Stage, where you'll receive CT-0508; • The Post Dose & Follow-Up Stage, where we will observe any changes in your health and monitor your disease through the end of the trial.

Incentives

$50 stipend and reimbursement for travel (mileage and hotel)

In-person visits:
Variable - up to 19 study visits

Phone or online visits:
Variable - based on worsened disease

Total length of participation:
13 months - this includes treatment and follow up

Looking for Specific Volunteers

Able to participate:

Confirmed diagnosis of tumor that is positive for HER2, evaluated by staining and molecular testing of diagnostic tumor biopsy material
Recurrent or relapsed solid tumors for which there are no curative treatments; must have either failed or unlikely to respond to approved HER2-targeted therapy
Presence of at least 1 site of disease that is able to be measured to evaluate response to treatmen
Willingness to comply with study requirements (agree to biopsy, etc.)
Adequate performance status (ability to perform daily tasks) and organ function

Not eligible if:

Diagnosis of immunodeficiency; or requirement for corticosteroid at doses of 10 mg daily prednisone (or equivalent) or other drugs that dampen immune system
Known and previously documented HIV; active infection with Hepatitis B or C; any other uncontrolled and active bacterial, viral, or fungal infection
Cardiac disorders as specific in protocol
History of reactions to any of the following: granulocyte colony stimulating factors (pegfilgrastim, filgrastim), albumin, DMSO, Dextran 40, or plasma-lyte
Washout exclusionary criteria related to prior treatments

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Immunotherapy Team
UNCImmunotherapy@med.unc.edu

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Yara Abdou
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Phase 1 Trials (all cancers))

IRB Number

20-1796

ClinicalTrials.gov

NCT04660929