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New treatment option for Breast Cancer
Official title Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells
ClinicalTrials.gov ID: NCT06347068
What this study is testing
What is iC9-CAR.B7-H3 T Cell Therapy?
iC9-CAR.B7-H3 T Cell Therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Also referred to as iC9-CAR.B7-H3 T cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed/refractory triple-negative breast cancer (TNBC).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Unless otherwise noted, people must meet all of the following criteria to participate in in all phases of the study:
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information...
- Age ≥ 18 years at the time of consent.
- Karnofsky score of \> 60% (see APPENDIX VI- Karnofsky Scale))
- Histologically confirmed TNBC (ER-, PR-, HER2-negative)
You likely can't join if
- Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.
- people with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works...
- Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1
See the full eligibility criteria
- Unless otherwise noted, people must meet all of the following criteria to participate in in all phases of the study:
- 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...
- Age ≥ 18 years at the time of consent.
- Karnofsky score of \> 60% (see APPENDIX VI- Karnofsky Scale))
- Histologically confirmed TNBC (ER-, PR-, HER2-negative)
- ER- and PR-negative: defined as \< 1% staining by immunohistochemistry (IHC)
- HER2-negative: defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio \< 2.0
- Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.
- people with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for this trial.
- Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.