RecruitingPhase 1NCT06347068

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

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

Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

42 participants

Start Date

Jun 27, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Relapse Resistant Cancer

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a CAR-T cell therapy targeting a protein called B7-H3 for women with triple-negative breast cancer (TNBC) — a type of breast cancer that lacks three common hormone receptors, making it harder to treat. The modified immune cells are made from the patient's own blood (autologous), and the therapy includes a safety switch to turn off the cells if needed. **You may be eligible if...** - You are 18 or older - You have been diagnosed with triple-negative breast cancer (confirmed by tumor biopsy) - Your overall health and physical function are reasonably good (Karnofsky score above 60%) **You may NOT be eligible if...** - You have had symptoms from brain metastases - Your organ function (heart, liver, kidneys) is not adequate to support the therapy - You are pregnant or breastfeeding - You have an active serious infection or autoimmune condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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