RecruitingHepatocellular Carcinoma
Study Of B7H3 CAR-T Cells in Treating Advanced Liver Cancer
Eligible age
18–70 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: The Affiliated Hospital of Xuzhou Medical University
You may qualify if…
- ✓ 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:
You may not qualify if…
- ✕ 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.
Source: ClinicalTrials.gov · NCT05323201 · last updated 2022-04-12