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

NCT04973098 | Unknown Phase 1 DMC

• 1 other identifier: CT0181-CG1202
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Hepatocellular Carcinoma

Keywords

Carcinoma; Hepatocellular Neoplasms

Outcome Measures

Primary Outcomes (4)

• 1.Dose-Limiting Toxicity（DLT）

  Safety

  28days

• Maximal Tolerable Dose（MTD）

  tolerability evaluation

  28days

• Treatment Emergent Adverse Event（TEAE）

  Incidence rate

  28days

• Adverse Event of Special Interest

  Incidence rate

  28 days

Study Arms (1)

5 dose levels each with or without lymphocyte clearance were tentatively determined.

EXPERIMENTAL

CT0181 Cells were transfused after lymphocyte clearance with fludarabine and cyclophosphamide or without lymphocyte clearance.

Biological: CT0181 Cells

Interventions

CT0181 Cells BIOLOGICAL

5 dose levels each with or without lymphocyte clearance were tentatively determined.

Also known as: CT0181 humanized anti GPC3 autogenous T Cell injection

5 dose levels each with or without lymphocyte clearance were tentatively determined.

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.
• 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;
• Expected survival is \> 12 weeks;
• Cirrhosis status Child-Pugh score: ≤7
• Eastern Cooperative Oncology Group Performance Status score: 0 to 1 point;
• 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 ;
• 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 . 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;
• Subjects have known active autoimmune diseases
• 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 ;
• 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 Programmed cell Death-1/Programmed cell Death-Ligand 1 monoclonal antibody therapy within 4 weeks or local treatment and systemic chemiotherapy within 2 weeks or immunotheray and molecular targeted drugs within 1 week before apheresis;

Sponsors & Collaborators

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

Study Sites (1)

Peking University

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Lin Shen

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Shen

CONTACT

86-10-88196561; linshenpku@163.com

Changsong Qi

CONTACT

86-10-88196561; xiwangpku@126.com

Study Design

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

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: August 5, 2021
• Primary Completion: August 1, 2022
• Study Completion: June 1, 2023
• Last Updated: November 4, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)