Treatment using CAR-T cells targeting B7-H3 for triple-negative breast cancer
Study of Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing the Inducible Caspase 9 Safety Switch in Subjects With Triple Negative Breast Cancer
This study is testing a new CAR-T cell treatment aimed at a specific target for people with hard-to-treat triple-negative breast cancer to see if it is safe and how much can be given.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation, CAR-T, chimeric antigen receptor, cyclophosphamide, fludarabine |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06347068 on ClinicalTrials.gov |
What this trial studies
This phase 1, single-center, open-label study investigates the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) targeting the B7-H3 antigen in patients with relapsed or refractory triple-negative breast cancer (TNBC). Eligible participants will undergo lymphodepletion with cyclophosphamide and fludarabine before receiving the experimental iC9-CAR.B7-H3 T cell therapy. The study employs a modified 3+3 design to determine the maximum tolerated dose (MTD) and establish a recommended phase 2 dose (RP2D) based on safety and manufacturing feasibility.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed triple-negative breast cancer who have relapsed or are refractory to standard treatments.
Not a fit: Patients with symptomatic central nervous system involvement or multiple metastases requiring whole-brain radiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with difficult-to-treat triple-negative breast cancer.
How similar studies have performed: Other studies using CAR-T cell therapies have shown promising results in various cancers, indicating potential success for this novel approach in TNBC.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Yara E Abdou, MD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Caroline Babinec
- Email: UNCImmunotherapy@med.unc.edu
- Phone: 919-445-4208
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.