Phase I Clinical Trial of CT0180 Cells in the Treatment of Hepatocellular Carcinoma

NCT04756648 | Active Not Recruiting Phase 1

• 1 other identifier: CT0180-CG1203
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I Clinical Study ofCT0180 cells in Patients with Advanced Hepatocellular Carcinoma

Conditions

Advanced Hepatocellular Carcinoma

Keywords

Advanced Hepatocellular Carcinoma; CT0180 Cells; GPC3

Outcome Measures

Primary Outcomes (4)

• Dose-Limiting Toxicity（DLT）

  Safety

  28 days

• Maximal Tolerable Dose（MTD）

  tolerability evaluation

  28 days

• Adverse Event（AE）

  Incidence rate

  28 days

• Adverse Event of Special Interest （ AESI）

  Incidence rate

  28 days

Secondary Outcomes (8)

• Number of cells

  52 weeks

• Treatment Emergent Adverse Event(TEAE)

  52 weeks

• Antitumor efficacy-Objective response rate (ORR)

  52 weeks

• Antitumor efficacy-Duration of response (DOR)

  52 weeks

• Antitumor efficacy-Progression-free survival (PFS)

  52 weeks

Study Arms (1)

CT0180 cells

EXPERIMENTAL

CT0180 Cells infusion after lymphocyte-depleting with fludarabine and cyclophosphamide.

Drug: CT0180 Cells

Interventions

CT0180 Cells DRUG

Five dose levels were tentatively determined.

Also known as: CT0180 humanized anti GPC3 autogenous T Cell injection

CT0180 cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years, either sex；
• Patients with clinically or pathologically confirmed hepatocellular carcinoma were treated with surgery or local treatment It is not suitable for surgery or local radical treatment;
• Progression or intolerance after at least one previous systemic treatment, or due to specific reasons unable to receive systemic treatment. Systemic therapy can include: Programmed Death 1（PD-1） / programmed cell death-Ligand 1（PD-L1） monoclonal antibody Antibodies, molecular targeted drugs (e.g. sorafenib, regofinib, renvastinib)and conventional chemotherapy, etc;
• According to Barcelona Clinic Liver Cancer（BCLC）, the patients are classified into Grade C or Grade B unsuitable for local treatment/progressive disease after local treatment;
• In tumor tissue samples GPC3 is detected positive by immunohistochemistry (IHC);
• According to Response Evaluation Criteria in SolidTumors（RECIST1.1）,patients have at least one evaluable target lesion, defined as: the longest diameter of non-lymph node lesion ≥ 10 mm, or the shortest diameter of lymph node lesion ≥ 15 mm); hepatic lesions require arterial phase contrast enhancement;
• Expected survival is \> 12 weeks;
• Cirrhosis status Child-Pugh score: Grade A;
• Eastern Cooperative Oncology Group（ ECOG） Performance Status score: 0 to 1 point;
• If the patient is HBsAg positive or HBcAb positive, HBV-DNA should be \<2000 IU/ml. HBsAg positive patients must receive antiviral treatment ;
• Acceptable routine blood test showing no contraindication to the lymphodepletion pretreatment and adequate liver, renal, cardiovascular, respiratory function;
• Have venous accesses for apheresis;
• Subjects of childbearing age must undergo a serum pregnancy test within 14 days before the initiation of the study and the result must be negative. In addition, they should be willing to use a reliable method of contraception during the trial (within 52 weeks after cell infusion); male subjects whose spouses are women of childbearing age should undergo sterilization surgery or agree to use a reliable method of contraception during the trial;
• Understand and sign informed consent.

You may not qualify if:

• Pregnant or breast-feeding women;
• Hepatitis virus C antibodies ,human immunodeficiency virus（HIV） antibodies or Syphilis Serological tests are positive;
• Any uncontrol active infection, including but not limited to active tuberculosis;
• Have clinically significant thyroid dysfunction except the stable control after treatment;
• Previous or present hepatic encephalopathy;
• Current clinically significant ascites;
• Imaging results:≥50% of the liver is replaced by tumor or portal vein main tumor thrombus, or metastases to the central nervous system, or tumor thrombus invasion of mesenteric vein / inferior vena cava;
• Patients with a history of organ transplantation or waiting for organ transplantation (including liver transplantation);
• The side effects caused by the previous treatment of the subjects did not return to Common Terminology Criteria for Adverse Events（CTCAE） ≤1; except hair loss and other tolerable events determined by investigator;
• Patients who had received systemic steroids or other immunosuppressive agents within 7 days before apheresis, except inhaled steroids;
• History of severe allergy ,allergic to CT0180 cell fluid adjuvant such as Dimethyl sulfoxide（DMSO）;
• Has signs of central nervous system disease or an abnormal neurological examination with clinical significance;
• Subjects with unstable or active ulcers, gastrointestinal bleeding, or pump inhibitor intolerance;
• Patients with a history of organ transplantation or waiting for organ transplantation;
• Previously received anti-PD-1/ PD-L1 monoclonal antibody therapy within 4 weeks or local treatment and systemic chemotheray within 2 weeks or immunotheray and molecular targeted drugs within 1 week before apheresis;

Sponsors & Collaborators

• Zhejiang University: lead
• CARsgen Therapeutics Co., Ltd.: collaborator

Study Sites (1)

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

Study Officials

• Tingbo Liang

  The First Affiliated Hospital, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 16, 2021
• Study Start: March 10, 2021
• Primary Completion: March 31, 2023
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)