Study Of B7H3 CAR-T Cells in Treating Advanced Liver Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
fhB7H3.CAR-Ts: fhB7H3.CAR-Ts will be transhepatic arterial infused after lymphodepletion. Three dose levels will be evaluated: Dose Level 1 (1×10\^6/kg), dose Level 2 (3×10\^6/kg) and dose Level 3 (5×10\^6/kg). If dose limiting toxicities (DLTs) are observed in each doses, Dose Level -1 (0.5×10\^6/kg /infusion) will be evaluated.
Fludarabine: 30 mg/m2 i.v. for 3 consecutive days (Day -5\~Day -3)
Cyclophosphamide: 750 mg/m2 i.v. for once (Day -5)
Study summary
This is single center, open-label phase I/II, non-randomized study which will enroll patients with recurrent advanced hepatocellular carcinoma to evaluate the safety, feasibility, and efficacy of fully human B7H3 CAR-T in treating hepatocellular carcinoma.
Eligibility
Primary outcome measure(s)
- Safety of fhB7H3.CAR-T cells — 1 month
Adverse events, including the type, frequency, severity and duration, such as cytokine release syndrome (CRS), on-target off-tumor, immune effector cell-associated neurotoxicity syndrome, will be monitored and assessed. - Objective response of fhB7H3.CAR-T cells — 1 month
Objective response rate (ORR) including complete response (CR), partial response (PR), and/or stable disease, will be determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Complete Response (CR): disappearance of all target lesions, all target nodules must be reduced to normal size (short axis \<10 mm). 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. Progressive Disease (PD): 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | Recruiting |
More The Affiliated Hospital of Xuzhou Medical University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05323201 on ClinicalTrials.gov ↗ ← All trials in China