Advanced Hepatocellular CarcinomaPhase 1NCT04973098
Phase I Clinical Trial of CT0181 Cells in the Treatment of Hepatocellular Carcinoma
A Phase 1 study testing CT0181 Cells in people with Advanced Hepatocellular Carcinoma, run by Peking University at 1 site in China.
Trial summary
A Phase I Clinical Study of CT0181 cells in Patients with Advanced Hepatocellular Carcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- CT0181 Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2021to Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
- Previously received GPC3 targeted therapy;
- Major surgery or significant trauma occurred within 4 weeks before apheresis, or it is expected that major surgery needs to be performed during the trial;
- Patients who had incurable malignant tumors in the past 5 years or at the same time, except cervical cancer in situ and basal cell carcinoma of skin;
- Other serious diseases that may restrict the subjects from participating in the trial ；
- The researcher assessed that the subjects were unable or unwilling to comply with the requirements of the trial protocol.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University
Beijing, Beijing Municipality, 100142
Lin Shen, +86-13911219511, doctorshenlin@sina.com
Changsong Lin, +86-13811394004, xiwangpku@126.com
About this study
Official title: 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
A Phase I Clinical Study of CT0181 cells in Patients with Advanced Hepatocellular Carcinoma
Read the 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.
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- CT0181 Cells
- Keywords
- Carcinoma, Hepatocellular Neoplasms
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT0181 CellsBiological
Also called CT0181 humanized anti GPC3 autogenous T Cell injection
5 dose levels each with or without lymphocyte clearance were tentatively determined.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: CT0181 Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Dose-Limiting Toxicity（DLT）
Safety
Measured: 28days
Maximal Tolerable Dose（MTD）
tolerability evaluation
Measured: 28days
Treatment Emergent Adverse Event（TEAE）
Incidence rate
Measured: 28days
Adverse Event of Special Interest
Incidence rate
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start5 Aug 2021
- Primary completionAug 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- CARsgen Therapeutics Co., Ltd.
- Responsible party
- Principal investigator, Shen Lin, Peking University
- Investigators
- Lin Shen, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973098
- Sponsor's protocol ID
- CT0181-CG1202
- Status last verified
- Nov 2021
- First submitted
- 13 Jul 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04973098
- Acronym / sponsor ID
- CT0181-CG1202
- Conditions
- Advanced Hepatocellular Carcinoma
- Keywords
- Carcinoma, Hepatocellular Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- CARsgen Therapeutics Co., Ltd.
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5 dose levels each with or without lymphocyte clearance were tentatively determined. | Experimental | Biological: CT0181 CellsCT0181 Cells were transfused after lymphocyte clearance with fludarabine and cyclophosphamide or without lymphocyte clearance. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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);
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT0181 CellsAlso: CT0181 humanized anti GPC3 autogenous T Cell injection5 dose levels each with or without lymphocyte clearance were tentatively determined. | Biological | 5 dose levels each with or without lymphocyte clearance were tentatively determined. |
Primary outcome
1.Dose-Limiting Toxicity（DLT）
Time frame: 28days
Safety
Maximal Tolerable Dose（MTD）
Time frame: 28days
tolerability evaluation
Treatment Emergent Adverse Event（TEAE）
Time frame: 28days
Incidence rate
Adverse Event of Special Interest
Time frame: 28 days
Incidence rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Shen principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CT0181 Cells in people with Advanced Hepatocellular Carcinoma, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Shen (86-10-88196561, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.Dose-Limiting Toxicity（DLT） (time frame: 28days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.