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

NCT05323201 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-04-12

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

fhB7H3.CAR-Ts

fhB7H3.CAR-Ts will be transhepatic arterial infused after lymphodepletion. Three dose levels will be evaluated: Dose Level 1 (1×10\^6/kg), dose Level 2 (3×10\^6/kg) and dose Level 3 (5×10\^6/kg). If dose limiting toxicities (DLTs) are observed in each doses, Dose Level -1 (0.5×10\^6/kg /infusion) will be evaluated.

DRUG

Fludarabine

30 mg/m2 i.v. for 3 consecutive days (Day -5\~Day -3)

DRUG

Cyclophosphamide

750 mg/m2 i.v. for once (Day -5)

Sponsors & Collaborators

  • Xuzhou Medical University

    collaborator OTHER

  • IIT MediTech Co. Ltd

    collaborator UNKNOWN

  • The Affiliated Hospital of Xuzhou Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2024-02-10
Completion
2027-02-10

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05323201 on ClinicalTrials.gov