Study Of B7H3 CAR-T Cells in Treating Advanced Liver Cancer
A Single-Arm, Open-Label Study to Evaluate Safety and Efficacy of B7H3 or HBsAg Targeting CAR-T in Treating Advanced Hepatocellular Carcinoma
The Affiliated Hospital of Xuzhou Medical University
15 participants
Feb 10, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria12
- Subjects should be 18-70 years old.
- Subject has adequate performance status as defined by ECOG score of≤ 2.
- Expected life expectancy is no less than 12 weeks.
- Subjects must have histologically or cytologically confirmed unresectable, recurrent and / or metastatic hepatocellular carcinoma (HCC). And tumor tissues are measured positive for B7H3 expression.
- Child-Pugh A, B grade.
- Blood routine:
- white blood cell count≥ 2.5 × 10\^9 / L; hemoglobin≥ 9 g/dL; platelet count≥ 50 × 10\^9 / L; lymphocyte proportion≥ 15 %;
- Adequate organ function. Patients' main organs ( heart, lung, liver, kidney, etc. ) function well:
- ALT and AST≤ 5 × ULN; ALB≥ 30 g/L； Total bilirubin≤ 2.5 × ULN； Serum creatinine\< 220μmol/L; Indoor oxygen saturation ≥ 95 %; Left ventricular ejection fraction≥ 40%;
- No allergic reaction to contrast agents.
- Procurement and T-cell production eligibility: a previously evaluation confirmed autologous peripheral blood mononuclear cells can be used for T-cell production.
- Patients or their legal guardians voluntarily participate in and sign the informed consent form.
Exclusion Criteria16
- The subject is a pregnant or lactating woman.
- The subjects have infectious diseases (such as HIV, syphilis, active tuberculosis, etc.);
- The subject has active infection or coagulation dysfunction.
- Subjects with previous hepatic encephalopathy.
- The subject is on anticoagulation or antiplatelet therapy.
- The subject is an organ transplant or waiting for transplant.
- Subjects with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation.
- The subjects are highly allergic or have a history of severe allergies.
- The subject has received chemotherapy/radiotherapy within the past 4 weeks.
- The subject has a history of cellular immunotherapy or antibody therapy.
- The subject is receiving systemic hormone therapy.
- Subjects with systemic infection or severe local infection requiring anti-infection treatment.
- The subject has dysfunction of important organs such as heart, lung, brain, liver, and kidney.
- The subject is participating in other clinical research.
- The doctor believes that there are other reasons not to be included in the treatment.
- Unwilling or unable to provide consent/assent for participation in the study.
Interventions
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.
30 mg/m2 i.v. for 3 consecutive days (Day -5\~Day -3)
750 mg/m2 i.v. for once (Day -5)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05323201