Clinical trialPhase 1NCT05344664
Novel GPC3 CAR-T Cell Therapy for Hepatocellular Carcinoma
A Phase 1 study testing GPC3-CAR-T cells, run by Peking University.
Trial summary
This is a single-center, single-arm, open-label Phase I study to evaluate the safety and efficacy of GPC3-CAR-T cell immunotherapy in the treatment of hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- GPC3-CAR-T cells
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2022to 1 Feb 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, ≤ 65 years old, gender is not limited; 2. Hepatocellular carcinoma diagnosed by histological/cytological examination, or liver cirrhosis who meet the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Study of Liver Diseases (AASLD), are not suitable for surgery or local treatment, and have received first-line standardized systemic treatment Later failure or intolerance or refusal to accept standard treatment; Definition of intolerance: According to CTCAEv5.0, hematological toxicity of grade ≥IV or non-hematological toxicity of grade ≥III or damage to major organs such as heart, liver, kidney, etc. of grade ≥II occurs during treatment; Definition of treatment failure: disease progression (PD) during treatment or recurrence after the end of treatment (including postoperative recurrence).
- 3. The tumor tissue samples were positive for GPC3 by immunohistochemistry (IHC); 4. At least one measurable lesion (according to RECIST1.1), the long diameter of non-lymph node lesions ≥ 1.0cm, or the short diameter of lymph node lesions ≥ 1.5cm, and intrahepatic lesions require arterial phase enhancement imaging.
- 5. The Barcelona Clinic Liver Cancer (BCLC) staging system is C stage or B stage that is not suitable for local therapy or fails local therapy; 6. Child-Pugh score A or good B (≤7 points); 7. ECOG score 0-1 within one week before enrollment; 8. Expected survival period ≥ 12 weeks; 9. Normal function of major organs: Blood routine: white blood cell count ≥3×109/L, absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin (Hb) ≥85g/L; platelet count ≥75×109/L (14 Days without blood transfusion, not corrected with drugs such as hematopoietic factors); Blood biochemistry: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal (ULN), total bilirubin (TBIL) ≤ 2.5 times the upper limit of normal (ULN); creatinine (cCr) ≤1.5 times the upper limit of normal value (ULN); 10. Women of childbearing age must have a negative serological pregnancy test during the screening period and within 14 days before the reinfusion of cells; and are willing to use reliable methods of contraception during the test and 12 months after cell infusion; for partners of childbearing age Female male subjects, should undergo surgical sterilization, or agree to use a reliable method of contraception during the trial and for 12 months after cell reinfusion.
- 11. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Who cannot join
- Active infection that is difficult to control;
- HIV antibody positive, syphilis serological test positive;
- Past or current hepatic encephalopathy (HE);
- Have a history of organ transplantation or are waiting for organ (including liver transplantation) transplantation (including hematopoietic stem cell transplantation);
- Those with organ failure:
- Heart: New York Heart Association (NYHA) cardiac function class C-D;
Show all 21Show fewer
- Kidney: renal failure stage and uremia stage;
- Lung: symptoms of respiratory failure;
- Brain: people with impaired consciousness.
- Are receiving systemic steroid therapy (≥0.5mg/kg/day methylprednisolone or equivalent);
- The toxicity or complications caused by previous intervention or treatment have not recovered to grade 2 or below (except for alopecia);
- Imaging results show: >50% of the liver has been occupied by tumor, or hepatic portal vein tumor thrombus, or mesenteric/inferior vena cava-tumor thrombus invasion;
- Previously received other genetically modified T cell products (such as CAR-T or TCR-T), or treatment targeting GPC3;
- Received anti-PD-1/PD-L1 monoclonal antibody treatment within 4 weeks before apheresis; received local or systemic treatment such as surgery, interventional therapy, radiotherapy, and ablation for the research disease within 2 weeks before apheresis Systemic chemotherapy; or received immunotherapy such as thymosin, interferon, or any Chinese herbal medicine or proprietary Chinese medicine for liver cancer control within 1 week before apheresis; or received sorafenib, regorafenone within 1 week before apheresis Targeted drug therapy such as ni and lenvatinib;
- Clinically significant, uncontrollable ascites (defined as: physical examination with positive signs of ascites or ascites that needs to be controlled by intervention (only those with ascites shown by imaging but not requiring intervention can be included));
- Diagnosed with other malignant tumors within 3 years before screening, except for those who have been treated for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or have undergone radical resection of carcinoma in situ;
- There is a history of central nervous system (CNS) metastasis or any evidence (as assessed by the investigator, those with stable disease can be considered for inclusion);
- Those with mental illness or history of drug abuse;
- Other serious diseases that may limit the participation of subjects in this trial (such as poorly controlled diabetes mellitus, left ventricular ejection fraction (LVEF) <50%, myocardial infarction or unstable arrhythmia or abnormal arrhythmia within the past 6 months. Stable angina pectoris, pulmonary embolism, chronic obstructive pulmonary disease, interstitial lung disease, clinically significant abnormal pulmonary function tests); or current active gastric ulcer, gastrointestinal bleeding, or a clear tendency to gastrointestinal bleeding);
- Pregnant or lactating women;
- The investigator believes that there are other factors that are not suitable for inclusion or that affect subjects participating in or completing the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Efficacy of Novel GPC3 CAR-T Cells in the Treatment of Hepatocellular Carcinoma Exploratory Clinical Studies
This is a single-center, single-arm, open-label Phase I study to evaluate the safety and efficacy of GPC3-CAR-T cell immunotherapy in the treatment of hepatocellular carcinoma.
Read the detailed description
This study is a single-center, dose-escalation, prospective, exploratory study to evaluate the safety and efficacy of GPC3 CAR-T cells in subjects with hepatocellular carcinoma. The study was divided into two phases: dose escalation and dose expansion. The total study duration is expected to be 2 years. The total time for each subject to participate in the study is expected to be more than 1 year, including the screening period, non-myeloablative chemotherapy pretreatment, cell infusion-observation period, follow-up period, and then enter the survival follow-up, followed by telephone follow-up every 2 months, Collect subject survival information.
- Being tested
- GPC3-CAR-T cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPC3-CAR-T cellsBiological
The patients will receive one dose of GPC3-CAR-T.The dosage ranges from3×10^6 to 1×10^8 CAR-T+/kg.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of adverse events
Percentage of participants with adverse events.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start14 Apr 2022 (estimated)
- Primary completion14 Oct 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344664
- Sponsor's protocol ID
- HXYT-I-017
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Novel GPC3 CAR-T Cells in the Treatment of Hepatocellular Carcinoma Exploratory Clinical Studies
- ClinicalTrials.gov ID
- NCT05344664
- Acronym / sponsor ID
- HXYT-I-017
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 14 Apr 2022 (estimated)
- Primary completion
- 14 Oct 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 25 Apr 2022 (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.
This is a single-center, single-arm, open-label Phase I study to evaluate the safety and efficacy of GPC3-CAR-T cell immunotherapy in the treatment of hepatocellular carcinoma.
Detailed description
This study is a single-center, dose-escalation, prospective, exploratory study to evaluate the safety and efficacy of GPC3 CAR-T cells in subjects with hepatocellular carcinoma. The study was divided into two phases: dose escalation and dose expansion. The total study duration is expected to be 2 years. The total time for each subject to participate in the study is expected to be more than 1 year, including the screening period, non-myeloablative chemotherapy pretreatment, cell infusion-observation period, follow-up period, and then enter the survival follow-up, followed by telephone follow-up every 2 months, Collect subject survival information.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old, ≤ 65 years old, gender is not limited; 2. Hepatocellular carcinoma diagnosed by histological/cytological examination, or liver cirrhosis who meet the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Study of Liver Diseases (AASLD), are not suitable for surgery or local treatment, and have received first-line standardized systemic treatment Later failure or intolerance or refusal to accept standard treatment; Definition of intolerance: According to CTCAEv5.0, hematological toxicity of grade ≥IV or non-hematological toxicity of grade ≥III or damage to major organs such as heart, liver, kidney, etc. of grade ≥II occurs during treatment; Definition of treatment failure: disease progression (PD) during treatment or recurrence after the end of treatment (including postoperative recurrence).
- 3. The tumor tissue samples were positive for GPC3 by immunohistochemistry (IHC); 4. At least one measurable lesion (according to RECIST1.1), the long diameter of non-lymph node lesions ≥ 1.0cm, or the short diameter of lymph node lesions ≥ 1.5cm, and intrahepatic lesions require arterial phase enhancement imaging.
- 5. The Barcelona Clinic Liver Cancer (BCLC) staging system is C stage or B stage that is not suitable for local therapy or fails local therapy; 6. Child-Pugh score A or good B (≤7 points); 7. ECOG score 0-1 within one week before enrollment; 8. Expected survival period ≥ 12 weeks; 9. Normal function of major organs: Blood routine: white blood cell count ≥3×109/L, absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin (Hb) ≥85g/L; platelet count ≥75×109/L (14 Days without blood transfusion, not corrected with drugs such as hematopoietic factors); Blood biochemistry: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal (ULN), total bilirubin (TBIL) ≤ 2.5 times the upper limit of normal (ULN); creatinine (cCr) ≤1.5 times the upper limit of normal value (ULN); 10. Women of childbearing age must have a negative serological pregnancy test during the screening period and within 14 days before the reinfusion of cells; and are willing to use reliable methods of contraception during the test and 12 months after cell infusion; for partners of childbearing age Female male subjects, should undergo surgical sterilization, or agree to use a reliable method of contraception during the trial and for 12 months after cell reinfusion.
- 11. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Key exclusion criteria (21 listed)
- Active infection that is difficult to control;
- HIV antibody positive, syphilis serological test positive;
- Past or current hepatic encephalopathy (HE);
- Have a history of organ transplantation or are waiting for organ (including liver transplantation) transplantation (including hematopoietic stem cell transplantation);
- Those with organ failure:
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 |
|---|---|---|
| GPC3-CAR-T cellsThe patients will receive one dose of GPC3-CAR-T.The dosage ranges from3×10^6 to 1×10^8 CAR-T+/kg. | Biological | – |
Primary outcome
Percentage of adverse events
Time frame: 3months
Percentage of participants with adverse events.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GPC3-CAR-T cells, run by Peking University.
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 4 inclusion and 21 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 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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, PhD (13911219511, doctorshenlin.@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of adverse events (time frame: 3months). 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 25 Apr 2022.