Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells

Toxicity: NCI-CTCAE

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)

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)

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.

The recommended phase 2 dose (RP2D)

The RP2D of iC9-CAR.B7-H3 T cells will be determined based on modified 3+3 dose finding rules and the tolerability of iC9-CAR.B7-H3 T cells will be assessed by NCI-CTCAE v5, ASTCT Consensus CRS Grading Criteria. ICANS will be graded according to the ASTCT Consensus ICANS Grading Criteria

Progression Free Survival (PFS)

PFS will be measured from the first day of lymphodepletion chemotherapy prior to iC9-CAR.B7-H3 T cell infusion to progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1 or death. Radiographic response will be measured by RECIST 1.1 indicating if the subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Overall Survival (OS)

OS will be measured from the first day of lymphodepleting chemotherapy prior to iC9-CAR.B7-H3 T cell infusion to the date of death for any cause.

The disease control rate (DCR)

DCR will be defined based on response evaluation criteria in solid tumors (RECIST1.1) and immune response evaluation criteria in solid tumors ( irRECIST) or death. RECIST1.1: Complete Response, the disappearance of all target lesions; Partial Response, \>=30% decrease in the sum of the longest diameter; Stable Disease, no response or less response than Partial or Progressive; or Progressive Disease, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. irRECIST: Complete Response ( irCR) disappearance of all lesions, no new lesions, lymph nodes \< 10 mm in short axis; Partial Response (irPR), ≥30% decrease in the sum of lesions; Stable response, not meeting criteria for irCR, irPR, or Progressive Disease (irPD); Progressive Disease(irPD), ≥20% increase in tumor burden and minimum 5 mm absolute increase in compared to nadir.