Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

RECRUITING

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

Lead Sponsor:

The Affiliated Hospital of Xuzhou Medical University

Collaborating Sponsors:

Xuzhou Medical University

IIT MediTech Co. Ltd

Conditions:

Hepatocellular Carcinoma

Eligibility:

All Genders

18-70 years

Phase:

PHASE1

PHASE2

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 full...

Detailed Description

Chimeric antigen-modified T cells are genetically modified T cells that use gene transduction technology to introduce CARs, containing tumor antigen-specific recognition single-chain antibodies and T ...

Eligibility Criteria

Inclusion

  • Subjects should be 18-70 years old.
  • Subject has adequate performance status as defined by ECOG score of≤ 2.
  • Expected life expectancy is no less than 12 weeks.
  • Subjects must have histologically or cytologically confirmed unresectable, recurrent and / or metastatic hepatocellular carcinoma (HCC). And tumor tissues are measured positive for B7H3 expression.
  • Child-Pugh A, B grade.
  • Blood routine:
  • white blood cell count≥ 2.5 × 10\^9 / L; hemoglobin≥ 9 g/dL; platelet count≥ 50 × 10\^9 / L; lymphocyte proportion≥ 15 %;
  • 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%;
  • No allergic reaction to contrast agents.
  • Procurement and T-cell production eligibility: a previously evaluation confirmed autologous peripheral blood mononuclear cells can be used for T-cell production.
  • Patients or their legal guardians voluntarily participate in and sign the informed consent form.

Exclusion

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

Key Trial Info

Start Date :

February 10 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 10 2027

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT05323201

Start Date

February 10 2022

End Date

February 10 2027

Last Update

April 12 2022

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China, 221002