Study of CAR-T Cells for Relapsed/Resistant Triple-Negative Breast Cancer
This study is testing a new treatment called iC9-CAR.B7-H3 T Cell Therapy for people with triple-negative breast cancer that has returned or is resistant to other treatments. This therapy uses your own immune cells (T cells) that are specially trained to find and fight cancer cells. Before receiving the iC9-CAR.B7-H3 T cells, you will receive two other medications, cyclophosphamide and fludarabine. The main goal of this study is to see how safe this new treatment is, especially looking for side effects like cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). The study plans to enroll 42 participants and is currently exploring different doses of the iC9-CAR.B7-H3 T cells.
- Study design
- This is a Phase 1, single-center, open-label study, meaning all participants and researchers will know what treatment is being given. It plans to enroll 42 participants.
- What's involved
- You would have cells collected to manufacture the iC9-CAR.B7-H3 T cells, and then receive cyclophosphamide and fludarabine before the iC9-CAR.B7-H3 T Cell Therapy. Your safety will be monitored for up to 8 weeks after the T cell infusion.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 4 weeks for general toxicity and immune effector cell-associated neurotoxicity syndrome (ICANS), and up to 8 weeks for Cytokine Release Syndrome (CRS) after receiving the T cells.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Yara Abdou, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center
Who to contact
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What this trial measures
- Toxicity: NCI-CTCAEUp to 4 weeks
Toxicity will be graded as the Number of participants with adverse events (AE)s AEs will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
- Toxicity: Cytokine Release Syndrome (CRS)Up to 8 weeks after infusion of Biological/Vaccine
CRS will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading. Grade 1 - Mild: Fever ≥38\^ o C, No hypotension, No hypoxia, Grade 2 - Moderate: Fever ≥38\^ o C, Hypotension not requiring vasopressors, Hypoxia requiring low-flow nasal cannula (≤6 L/minute) or blow-by, Grade 3 - Severe: Fever ≥ 38\^ o C, Hypotension requiring a vasopressor with or without vasopressin, Hypoxia requiring high-flow nasal cannula (\>6 L/minute), facemask, nonrebreather mask, or Venturi mask, Grade 4 - Life-threatening: Fever ≥38\^oC, Hypotension requiring multiple vasopressors (excluding vasopressin), Hypoxia requiring positive pressure (e.g. Continuous positive airway pressure, BiPAP, intubation, mechanical ventilation), Grade 5 - Death
- Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS)Up to 4 weeks
Neurotoxicity will be graded according to the Immune effector cell-associated neurotoxicity syndrome (ICANS) criteria. Immune effector cell-associated neurotoxicity syndrome (ICANS) symptoms will be graded according to the criteria outlined in the protocol on a scale from 1 (mild) to 4 (critical). Cytokine release syndrome (CRS) will be graded according to criteria outlined in the protocol on a scale from 1 (mild) to grade 5 (death).