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OncoMatch/Clinical Trials/NCT05323201

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

Is NCT05323201 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including fhB7H3.CAR-Ts and Fludarabine for hepatocellular carcinoma.

Phase 1/2RecruitingThe Affiliated Hospital of Xuzhou Medical UniversityNCT05323201Data as of Jun 2026Location: China

Treatment: fhB7H3.CAR-Ts · Fludarabine · CyclophosphamideThis 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.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

FludarabineCyclophosphamide

Other

fhB7H3.CAR-Ts

Cancer type

Hepatocellular Carcinoma

Biomarker criteria

Required: CD276 positive expression (positive)

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 70

Prior therapy

Cannot have received: chemotherapy

has received chemotherapy/radiotherapy within the past 4 weeks

Cannot have received: radiation therapy

has received chemotherapy/radiotherapy within the past 4 weeks

Cannot have received: cellular immunotherapy

history of cellular immunotherapy

Cannot have received: antibody therapy

history of ... antibody therapy

Cannot have received: systemic hormone therapy

receiving systemic hormone therapy

Lab requirements

Blood counts

white blood cell count≥ 2.5 × 10^9 / L; hemoglobin≥ 9 g/dL; platelet count≥ 50 × 10^9 / L; lymphocyte proportion≥ 15 %

Kidney function

Serum creatinine< 220μmol/L

Liver function

Child-Pugh A, B grade; ALT and AST≤ 5 × ULN; ALB≥ 30 g/L; Total bilirubin≤ 2.5 × ULN

Cardiac function

Left ventricular ejection fraction≥ 40%; Indoor oxygen saturation ≥ 95 %

Child-Pugh A, B grade. 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%; white blood cell count≥ 2.5 × 10^9 / L; hemoglobin≥ 9 g/dL; platelet count≥ 50 × 10^9 / L; lymphocyte proportion≥ 15 %

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT05323201 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior chemotherapy, radiation therapy, cellular immunotherapy disqualifies patients from enrollment.

Does this trial require CD276?

Yes, CD276 positive expression is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 70 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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