RecruitingPhase 1

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

United States42 participantsStarted 2024-06-27

Plain-language summary

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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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

Exclusion criteria

. Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.
. 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.
. Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Toxicity: NCI-CTCAE

Timeframe: Up to 4 weeks

Toxicity: Cytokine Release Syndrome (CRS)

Timeframe: Up to 8 weeks after infusion of Biological/Vaccine

Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS)

Timeframe: Up to 4 weeks

Trial details

NCT IDNCT06347068

SponsorUNC Lineberger Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05-22

Contact for this trial

Caroline Babinec

919-445-4208 UNCImmunotherapy@med.unc.edu

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