NCT05323201 Study Of B7H3 CAR-T Cells in Treating Advanced Liver Cancer
| NCT ID | NCT05323201 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | The Affiliated Hospital of Xuzhou Medical University |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2022-02-10 |
| Primary Completion | 2024-02-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2022-02-10 with a primary completion date of 2024-02-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Frequently Asked Questions
Who can join the NCT05323201 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05323201 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05323201 currently recruiting?
Yes, NCT05323201 is actively recruiting participants. Visit ClinicalTrials.gov or contact The Affiliated Hospital of Xuzhou Medical University to inquire about joining.
Where is the NCT05323201 trial being conducted?
This trial is being conducted at Xuzhou, China.
Who is sponsoring the NCT05323201 clinical trial?
NCT05323201 is sponsored by The Affiliated Hospital of Xuzhou Medical University. The trial plans to enroll 15 participants.
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