CAR-T Cells for Relapsed Pancreatic Cancer
This research study is testing a new treatment called iC9-CAR.B7-H3 T cells for people with pancreatic cancer that has returned after standard treatments. This treatment uses your own immune cells (T cells) that are specially modified to find and fight cancer cells. The main goal of this study is to see if iC9-CAR.B7-H3 T cells are safe and how well people tolerate them. Researchers will also be looking for side effects like cytokine release syndrome and neurotoxicity in the first four weeks after treatment. You may be able to join if you are 18 or older and have a good performance status (meaning you are generally able to do daily activities). This treatment is experimental and not yet approved by the FDA. The study plans to enroll 27 participants.
- Study design
- This is a Phase 1, single-center study where all participants will receive the iC9-CAR.B7-H3 T cell treatment. Researchers will start with a low dose and gradually increase it to find the safest and most effective amount.
- What's involved
- The iC9-CAR.B7-H3 T cell product will be given through an intravenous injection, which takes about 5 to 10 minutes.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure adverse events, cytokine release syndrome, and neurotoxicity 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 B7-H3 in PDAC
At a glance
Conditions
NCT06158139
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolinastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Ashwin Somasundaram, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Number of participants with adverse eventUp to 4 weeks
Number of participants with adverse event (AE)s as a measure of safety and tolerability of intraventricular administration iC9-CAR.B7-H3 T cells in subjects with progressive recurrent or refractory pancreatic cancer. 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) are defined as at least possibly related to iC9-CAR.B7-H3 T cell product administration.
- Cytokine Release SyndromeUp to 4 weeks
Cytokine Release Syndrome (CRS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading. Grade 1 - Mild (Symptomatic Management): Fever ≥38\^ o C, No hypotension, No hypoxia, Grade 2 - Moderate (Moderate Intervention): Fever ≥38\^ o C, Hypotension not requiring vasopressors, Hypoxia requiring low-flow nasal cannula (≤6 L/minute) or blow-by, Grade 3 - Severe (Aggressive Intervention): 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 (Life-sustaining intervention): 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: Death.
- NeurotoxicityUp to 4 weeks
Neurotoxicity will be graded according to the Central Nervous System (CNS) Toxicity criteria. Grade 0: Normal or no change from baseline exam at start of therapy, Grade 1: Mild lethargy and/or irritability or visual, motor, or sensory symptoms without change in neurological exam, Grade 2: Moderate lethargy, disorientation, or psychosis lasting \< 48 hours or mild increase in pre-existing neurological deficit, Grade 3: \>48hours of severe lethargy, but responsive to verbal stimuli or disorientation or psychosis lasting \>48 hours, Grade 4: Coma, unresponsive to verbal stimuli, increasing neurological deficit above grade 3, evidence of herniation, development of uncontrolled seizures, intracerebral hemorrhage.