Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 70Years
All Genders
NCT05323201

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

Led by The Affiliated Hospital of Xuzhou Medical University · Updated on 2022-04-12

15

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

T

The Affiliated Hospital of Xuzhou Medical University

Lead Sponsor

X

Xuzhou Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years
  • ECOG performance status of 2 or less
  • Expected life expectancy of at least 12 weeks
  • Histologically or cytologically confirmed unresectable, recurrent, or metastatic hepatocellular carcinoma
  • Tumor tissue positive for B7H3 expression
  • Child-Pugh liver function grade A or B
  • Blood counts: white blood cells at least 2.5 x 10^9/L; hemoglobin at least 9 g/dL; platelets at least 50 x 10^9/L; lymphocytes at least 15%
  • Adequate organ function including liver enzymes (ALT and AST) no more than 5 times upper limit of normal, albumin at least 30 g/L, total bilirubin no more than 2.5 times upper limit of normal, serum creatinine less than 220 µmol/L, oxygen saturation at least 95%, and left ventricular ejection fraction at least 40%
  • No allergic reaction to contrast agents
  • Suitable autologous peripheral blood mononuclear cells available for T-cell production
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Infectious diseases such as HIV, syphilis, or active tuberculosis
  • Active infection or blood clotting problems
  • History of hepatic encephalopathy
  • Currently on anticoagulation or antiplatelet therapy
  • Organ transplant recipients or awaiting transplant
  • Mental or psychological conditions preventing cooperation
  • History of severe allergies or high allergy risk
  • Chemotherapy or radiotherapy within the past 4 weeks
  • Previous cellular immunotherapy or antibody therapy
  • Receiving systemic hormone therapy
  • Systemic or severe local infection requiring treatment
  • Dysfunction of important organs like heart, lung, brain, liver, or kidney
  • Participation in other clinical research
  • Any other medical reason judged by the doctor to exclude participation
  • Unwilling or unable to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China, 221002

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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