Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Mar 28, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for patients with a specific type of breast cancer called triple-negative breast cancer (TNBC), which can be hard to treat. The study is testing a type of therapy known as CAR-T cells, which are specially modified immune cells that aim to attack cancer cells. This is a phase 1 study, meaning it is one of the first steps in understanding how safe this treatment is when given in increasing doses to patients whose cancer has returned or has not responded to other treatments.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of TNBC. They also need to be in good general health, as indicated by a specific scoring system. However, there are some exclusions, such as having symptoms related to brain involvement or other serious health issues that could interfere with the study. If participants join the trial, they can expect close monitoring for safety and to see how well the CAR-T cell treatment works against their cancer. This study is currently recruiting participants, and it is a chance to explore a new potential option for managing a challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Unless otherwise noted, subjects must meet all of the following criteria to participate in in all phases of the study:
• • 1. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative.
• • 2. Age ≥ 18 years at the time of consent.
• • 3. Karnofsky score of \> 60% (see APPENDIX VI- Karnofsky Scale))
• • 4. Histologically confirmed TNBC (ER-, PR-, HER2-negative)
• • 1. ER- and PR-negative: defined as \< 1% staining by immunohistochemistry (IHC)
• • 2. HER2-negative: defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio \< 2.0
• Exclusion Criteria:
• • 1. Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.
• • 2. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• • 3. Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1