Study Of B7H3 CAR-T Cells in Treating Advanced Liver Cancer

Recruiting now · Phase 1/Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT05323201

Run by

The Affiliated Hospital of Xuzhou Medical University

People needed

15

Starts

2022-02-10

Expected to finish

2027-02-10

Last updated by the study team

2022-04-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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