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Phase I Clinical Trial of CT0181 Cells in the Treatment of Hepatocellular Carcinoma | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Phase I Clinical Trial of CT0181 Cells in the Treatment of Hepatocellular Carcinoma

An Open-Label, Dose Escalation/Dose Exploration, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single/Multiple Infusion of CT0181 Injection in Patients With Advanced Hepatocellular Carcinoma

NCT04973098•Peking University

View on ClinicalTrials.gov

Summary

A Phase I Clinical Study of CT0181 cells in Patients with Advanced Hepatocellular Carcinoma

Detailed Description

Primary objectives: Evaluate the safety and tolerance of CT0181 cells in patients with advanced hepatocellular carcinoma within 28 days after the first infusion Secondary objectives: Evaluate the metabolic kinetics of CT0181 cells ; Evaluate overall safety and tolerability ; Evaluate the initial efficacy of CT0181 cell infusion in the treatment of advanced hepatocellular carcinoma with positive Glypican-3（GPC3 ）expression.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 18 to 75 years, either sex；
•2. 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;
•3. Progression or intolerance after at least one previous systemic treatment, or due to specific reasons unable to receive systemic treatment.
•4. 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;
•5. In tumor tissue samples GPC3 is detected positive by immunohistochemistry (IHC);
•6. According to Response Evaluation Criteria in SolidTumors（RECIST1.1）,patients have at least one evaluable target lesion;
•7. Expected survival is \> 12 weeks;
•8. Cirrhosis status Child-Pugh score: ≤7
•9. Eastern Cooperative Oncology Group Performance Status score: 0 to 1 point;
•10. If the patient is HBsAg positive or HBcAb positive, DNA of the hepatitis B virus should be \<2000 IU/ml. HBsAg positive patients must receive antiviral treatment ;
+3 more criteria

Exclusion Criteria

•1. Pregnant or breast-feeding women;
•2. Hepatitis virus C antibodies ,Human Immunodeficiency Virus（HIV） antibodies or Syphilis Serological tests are positive;
•3. Any uncontrol active infection, including but not limited to active tuberculosis;
•4. Have clinically significant thyroid dysfunction except the stable control after treatment;
•5. Previous or present hepatic encephalopathy;
•6. Current clinically significant ascites;
•7. 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;
•8. Subjects have known active autoimmune diseases
•9. 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;
•10. Patients who had received systemic steroids or other immunosuppressive agents within 7 days before apheresis, except inhaled steroids;
+10 more criteria

Locations (1)

Peking University

Beijing, Beijing Municipality, China

Key Dates

Start Date

August 5, 2021

Primary Completion Date

August 1, 2022

Completion Date

June 1, 2023

Last Updated

November 4, 2021

Enrollment

ESTIMATED participants

Conditions

Advanced Hepatocellular Carcinoma

Interventions

CT0181 Cells

BIOLOGICAL

Contacts

Lin Shen

CONTACT

86-10-88196561 linshenpku@163.com

Changsong Qi

CONTACT

86-10-88196561 xiwangpku@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 4, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase I Clinical Trial of CT0181 Cells in the Treatment of Hepatocellular Carcinoma

Inclusion Criteria

Exclusion Criteria

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