Studying iC9-CAR.B7-H3 T cells for Recurrent Ovarian Cancer
This study is testing a new treatment called iC9-CAR.B7-H3 T cells for women with ovarian cancer that has returned after standard treatments. The iC9-CAR.B7-H3 T cells are an experimental therapy that uses your own immune cells, specially modified to target cancer. Before receiving these cells, you will also be given cyclophosphamide and fludarabine. The main goal of this study is to find out how safe this treatment is, what dose can be given without causing too many side effects, and what the highest tolerable dose might be. Researchers will be looking closely for side effects like cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) for up to 4 weeks after treatment. This study is for women aged 18 or older.
- Study design
- This is a single-center, open-label study with an estimated 27 participants. It is designed to find the safest dose of the iC9-CAR.B7-H3 T cells.
- What's involved
- Blood will be collected to prepare the iC9-CAR.B7-H3 T cells. You will receive cyclophosphamide and fludarabine, followed by the iC9-CAR.B7-H3 T cells administered into your abdomen.
- Compensation
- Not stated in the trial record.
- Follow-up
- Toxicity will be measured for up to 4 weeks after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Linda Van Le, 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
Treatment emerged 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. Dose Limiting Toxicities (DLTs) is defined as at least possibly related to CAR.B7-H3T cell product administration.
- Toxicity: Cytokine Release Syndrome (CRS)Up to 4 weeks
Treatment emerged 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
Treatment emerged neurotoxicity will be graded according to the Immune effector cell-associated neurotoxicity syndrome (ICANS) criteria between Grades 1-5. immune Effector Cell-Associated Encephalopathy (ICE) Score is a neurological assessment score that quantifies the severity of neurologic impairment. Each item in the assessment is associated with the point value indicated. The higher ICE scores are the better = lower the ICAN grade. An ICE score of 10 indicates a normal neurological assessment while an ICE score of 0-2 ICE Score indicates a severe neurological impairment.