Anti-GPC3 CAR T for Treating Patients With Advanced HCC

Autologous T Cells Redirected to GPC3 for Treating Patients With Advanced HCC

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02395250

Enrollment

Registered

2015-03-23

Start date

2015-03-31

Completion date

2018-11-30

Last updated

2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Brief summary

The purpose of this study is to determine whether autologous T cells bearing chimeric antigen receptor that can specifically recognize glypican-3 (GPC3) is safe and effective for patients with relapsed or refractory hepatocellular carcinoma (HCC).

Interventions

BIOLOGICALanti-GPC3 CAR T

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Age of 18-70 years; 2. Pathologically confirmed advanced hepatocellular carcinoma (HCC); 3. ≥1 measurable target lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1); 4. Tumor tissue positive for GPC3 expression per immunohistochemical staining (IHC) assay; 5. Estimated survival \> 12 weeks; 6. Child-Pugh grade A; 7. ECOG performance score of 0-1; 8. HBV-DNA \< 200 IU/mL if positive for HBsAg or HBcAb. Patients positive for HBsAg shall receive anti-viral treatment per The guideline of prevention and treatment for chronic hepatitis B: a 2015 update; 9. Have adequate venous access for apheresis or venous blood collection; 10. White blood cells ≥ 2.5 x 109/L, platelet ≥ 60×109/L, haemoglobin ≥ 9.0 g/dL, lymphocyte ≥ 0.4×109/L 11. Serum albumin ≥ 30 g/dL, serum lipase and amylase≤1.5 upper limit of normal (ULN), serum creatinine ≤ 1.5 ULN and endogenous creatinine clearance ≥ 40mL/min, ALT and AST ≤ 5 ULN, Serum total bilirubin ≤ 2.5 ULN, Prothrombin Time is less than 4s longer than normal; 12. Negative serum pregnancy test within 14 days before CAR T infusion, and with willingness to use reliable contraceptive methods to avoid pregnancy until 12 months after CAR T infusions for females of childbearing age; Having undergone sterilization procedure or with willingness to use reliable contraceptive methods to avoid pregnancy for males with female partner of childbearing age during the study; 13. Able to understand and sign the informed consent form

Exclusion criteria

If the patient meets any of the

Design outcomes

Primary

Measure	Time frame
Adverse events attributed to the administration of the anti-GPC3 CAR T cells	2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026