NCT07493044

Brief Summary

This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
27mo left

Started Mar 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Jul 2028

First Submitted

Initial submission to the registry

March 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 27, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2028

Last Updated

May 14, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

March 19, 2026

Last Update Submit

May 12, 2026

Conditions

Advanced Hepatocellular Carcinoma (HCC)GPC3 Positive Hepatocellular Carcinoma

Keywords

GPC3 CAR-TCell therapyImmunotherapyHepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Dose Limiting Toxicity (DLT)

    Determining the DLT of Super CAR-T adoptive Immunotherapy.

    28 days after cell infusion

  • Maximum Tolerated Dose (MTD)

    Determining the MTD of Super CAR-T adoptive Immunotherapy.

    28 days after cell infusion

Secondary Outcomes (3)

  • Objective Response Rate(ORR)

    Research period

  • Progression Free Survival(PFS)

    One year after cell infusion

  • Overall Survival (OS)

    One year after cell infusion

Study Arms (1)

Dose escalation was performed in a 3+3 design

EXPERIMENTAL

The Super CAR-T dose toxicity test was escalated according to the following dose (positive cells) escalation schedule: Level 1 Level 2 Level 3

Biological: Super CAR-T

Interventions

Super CAR-TBIOLOGICAL

All participators received lymphoid-depleted preconditioning before Super CAR-T cells infusion. Super CAR-T cells were infused 3 days later.

Dose escalation was performed in a 3+3 design

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Understand and voluntarily sign the informed consent form prior to participating in any trial-related activities;
  • Be between 18 and 75 years of age; gender is not restricted;
  • Diagnosed with hepatocellular carcinoma (HCC) based on histopathological or cytological examination: Patients classified as inoperable Stage IIa, IIb, IIIa, or IIIb according to the Chinese National Liver Cancer (CNLC) staging system, or Stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system, or Stage B patients who are inoperable or unsuitable for local treatment; Child-Pugh liver function score ≤ 7;
  • Previous failure of or intolerance to at least two lines of standard systemic therapy;
  • The subject must provide a tumor sample or biopsy specimen collected within the past 2 years that meets the requirements and tests positive for GPC3 expression via immunohistochemistry;
  • At least one measurable lesion according to RECIST 1.1 criteria;
  • ECOG performance status of 0-1;
  • Expected survival of more than 3 months;
  • Echocardiography showing a left ventricular ejection fraction (LVEF) ≥50%;
  • Laboratory test results must meet at least the following criteria:
  • ANC ≥1.0×10⁹/L; PLT ≥75×10⁹/L; Hb ≥ 75 g/L; Creatinine clearance ≥ 60 mL/min; AST ≤ 5×ULN; ALT≤ 5×ULN; TBIL ≤ 3×ULN;
  • If HBsAg-positive or HBcAb-positive, HBV-DNA must be ≤ 2000 IU/mL;
  • Women of childbearing potential must have a negative pregnancy test prior to receiving study treatment; they must agree to use effective contraception during treatment.

You may not qualify if:

  • The subject has undergone major surgery within 2 weeks prior to apheresis, or is expected to undergo major surgery during the trial;
  • The subject is allergic to any component of the drugs to be used in this study, including but not limited to cyclophosphamide, fludarabine, CAR-T products, or their excipients;
  • Has not recovered from adverse reactions related to prior surgery or treatment to Grade ≤ 2; exceptions include alopecia, hyperpigmentation, and other conditions deemed by the investigator not to affect the subject's tolerability;
  • Has a clinically significant central nervous system (CNS) disorder (e.g., epilepsy, severe cerebrovascular stenosis) or other diseases presenting with significant neurological symptoms (including psychiatric disorders);
  • Received radiotherapy, systemic chemotherapy, or immune checkpoint inhibitors for the study disease within 2 weeks prior to apheresis; or received small-molecule targeted therapies such as sorafenib, regorafenib, or lenvatinib within 1 week prior to apheresis;
  • Received systemic glucocorticoid therapy within 7 days prior to single-plasma donation; patients currently using or who have recently used inhaled or topical glucocorticoids, as well as those on physiological-dose replacement therapy, are eligible for enrollment;
  • Any uncontrolled active infection, including but not limited to active tuberculosis or infectious diseases requiring systemic treatment;
  • Known active autoimmune diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, multiple sclerosis, and glomerulonephritis (patients with vitiligo are not excluded);
  • History of organ transplantation, autologous/allogeneic stem cell transplantation, or renal replacement therapy;
  • HCV antibody-positive with HCV RNA levels above the lower limit of detection; HIV antibody-positive; syphilis antibody-positive;
  • Currently pregnant or breastfeeding, or planning to become pregnant during the study;
  • Participants deemed by the investigator to be unable or unwilling to comply with the requirements of the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Gaungdong, 510700, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • BINKUI LI, Professor

    Sun Yat-Sen University Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

YING CHENG

CONTACT

86-02031605836chengy02@fineimmu.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 25, 2026

Study Start

March 27, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

July 30, 2028

Last Updated

May 14, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

The data is subject to the company's confidentiality requirements and therefore cannot be disclosed.

Locations

CN(1)