Using B7H3 CAR-T cells to treat 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

This study is testing if a new type of immune cell treatment can help people with advanced liver cancer by targeting and destroying specific cancer cells.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The Affiliated Hospital of Xuzhou Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, CAR-T, chimeric antigen receptor, cyclophosphamide, fludarabine
• Locations: 1 site (Xuzhou, Jiangsu)
• Trial ID: NCT05323201 on ClinicalTrials.gov

What this trial studies

This is a single-center, open-label phase I/II study aimed at evaluating the safety, feasibility, and efficacy of fully human B7H3 CAR-T cells in patients with recurrent advanced hepatocellular carcinoma. Participants will undergo lymphodepletion chemotherapy before receiving the CAR-T cell infusion, which is designed to target and eliminate B7H3-positive cancer cells. The study will monitor the survival of the CAR-T cells and assess therapeutic efficacy through regular blood tests following the infusion.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with unresectable, recurrent hepatocellular carcinoma that expresses B7H3.

Not a fit: Patients with liver cancer that does not express B7H3 or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel and effective option for patients with advanced liver cancer that is resistant to conventional therapies.

How similar studies have performed: Previous studies have indicated that targeting B7H3 in liver cancer may be promising, but this specific approach with fully human CAR-T cells is novel.

Eligibility criteria

Inclusion Criteria:

1. Subjects should be 18-70 years old.
2. Subject has adequate performance status as defined by ECOG score of≤ 2.
3. Expected life expectancy is no less than 12 weeks.
4. Subjects must have histologically or cytologically confirmed unresectable, recurrent and / or metastatic hepatocellular carcinoma (HCC). And tumor tissues are measured positive for B7H3 expression.
5. Child-Pugh A, B grade.
6. Blood routine:

   white blood cell count≥ 2.5 × 10\^9 / L; hemoglobin≥ 9 g/dL; platelet count≥ 50 × 10\^9 / L; lymphocyte proportion≥ 15 %;
7. 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%;
8. No allergic reaction to contrast agents.
9. Procurement and T-cell production eligibility: a previously evaluation confirmed autologous peripheral blood mononuclear cells can be used for T-cell production.
10. Patients or their legal guardians voluntarily participate in and sign the informed consent form.

Exclusion Criteria:

1. The subject is a pregnant or lactating woman.
2. The subjects have infectious diseases (such as HIV, syphilis, active tuberculosis, etc.);
3. The subject has active infection or coagulation dysfunction.
4. Subjects with previous hepatic encephalopathy.
5. The subject is on anticoagulation or antiplatelet therapy.
6. The subject is an organ transplant or waiting for transplant.
7. Subjects with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation.
8. The subjects are highly allergic or have a history of severe allergies.
9. The subject has received chemotherapy/radiotherapy within the past 4 weeks.
10. The subject has a history of cellular immunotherapy or antibody therapy.
11. The subject is receiving systemic hormone therapy.
12. Subjects with systemic infection or severe local infection requiring anti-infection treatment.
13. The subject has dysfunction of important organs such as heart, lung, brain, liver, and kidney.
14. The subject is participating in other clinical research.
15. The doctor believes that there are other reasons not to be included in the treatment.
16. Unwilling or unable to provide consent/assent for participation in the study.

Where this trial is running

Xuzhou, Jiangsu

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

Conditions Hepatocellular Carcinoma; Fully human B7H3 CAR-T; Recurrent Advanced Hepatocellular Carcinoma