HCCPhase 1NCT06891742
Phase I Study of OriC902 in Treatment of Advanced HCC
A Phase 1 study testing OriC902 in people with HCC, run by Peking University at 2 sites in China.
Trial summary
This is a Phase I clinical study evaluating the safety, pharmacokinetics, and initial efficacy of a GPC3-targeted chimeric antigen receptor autologous T cell injection (OriC902) in GPC3-positive advanced hepatocellular carcinoma (HCC) subjects Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC
- What is being tested?
- OriC902
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesChina
- Study dates
- 24 Feb 2025to 31 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Understand and voluntarily sign an informed consent form (ICF) prior to conducting any assessment/procedure related to the study;
- Ages 18 to 75 at the time of signing the ICF (including 18 and 75);
- HCC was diagnosed according to the Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 edition);
- Samples of liver tumor tissue or extrahepatic metastases within 1 year of signing the pre-screening informed consent were 1+ or more positive by immunohistochemical detection of GPC3 in tumor cells of at least 5% (dose escalation phase) or 10% (dose expansion phase);
- BCLC stage B HCC or BCLC stage C HCC that are not suitable for local therapy or relapse after local therapy and cannot be cured;
- Failure of standard treatment (including but not limited to targeted therapy, immunotherapy, or chemotherapy), which is determined by imaging as disease progression;
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- Child-Pugh A or B7 without hepatic encephalopathy;
- An ECOG score of 0 or 1;
- The expected survival is not less than 12 weeks;
- According to RECIST 1.1, subjects have at least one measurable lesion (lesions that have received local treatment such as radiotherapy need to be identified by imaging for definite progression), and the longest diameter at baseline for CT or MRI imaging evaluation must be ≥10 mm (except lymph nodes, whose short diameter must be ≥15 mm);
- Can carry out normal venous blood collection and machine simple collection, can establish the necessary venous access for collection, no contraindications for white blood cell collection;
- The researchers judged that lymphocyte clearance therapy could be performed;
- Fertile men and women of childbearing age must consent to the use of effective contraception from the signing of the master informed consent until 2 years after the study drug use. Women of reproductive age include women before menopause and women within 2 years after menopause. Blood pregnancy tests for women of childbearing age must be negative at the time of screening.
Who cannot join
- Central nervous system (CNS) metastasis, meningeal metastasis, or spinal cord compression;#
- Have a history of allogeneic hematopoietic stem cell transplantation or organ transplantation;
- A history of other primary malignancies within 3 years prior to study treatment, except for the following: Adequate treatment of cured carcinoma in situ (including but not limited to cervical carcinoma in situ, breast carcinoma in situ, etc.); Adequate treatment of cured localized basal cell or squamous cell carcinoma of the skin;
- Hepatitis B surface antigen (HBsAg) positive or Hepatitis B core antibody (HBcAb) positive, and HBV-DNA > 500 IU/mL. (For HBsAg positive or HBCAB-positive patients, antiviral therapy should be performed for at least 4 weeks before the first administration of the study drug, and antiviral therapy should be continued during the study);
- Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Syphilis specific antibody positive and syphilis non-specific antibody positive; Cytomegalovirus (CMV) DNA test positive, EBV-DNA test positive;
- People who are allergic to any of the drug components to be used in this study, including but not limited to antisepsis drugs (albumin paclitaxel, cyclophosphamide, fludarabine);
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- Previously received anti-tumor therapy against GPC3 targets, including but not limited to antibodies, ADCs (antibody-coupled drugs) and cell therapy;
- Investigators assessed that the intrahepatic tumor occupied more than 50% of the entire liver; The presence of main portal vein cancer thrombus or inferior vena cava cancer thrombus;
- Patients who received the following anti-tumor therapy before anapheresis: Received cytotoxic chemotherapeutic drugs within 28 days (combination chemotherapy) or 14 days (single agent chemotherapy) or 5 half-lives (whichever time the investigator determines is more appropriate); received any investigational drug/treatment within 28 days; received antibody drugs within 21 days; received a small molecule targeted drug within 14 days or 5 halflives (whichever is more appropriate in the investigator's judgment); received local treatment and/or radiotherapy within 28 days; received Chinese medicine with anti-tumor indications within 7 days;
- Major surgical treatment (other than liver space biopsy) was performed within 28 days prior to apheresis, or major surgical treatment was planned during the study period;
- Toxicity from previous antitumor therapy has not returned to grade 1 or baseline levels (according to NCI-CTCAE version 5.0), except in the following cases: alopecia, depigmentation, or partial chronic stable state grade 2 AE (such as hypothyroidism controlled by alternative therapy) and other toxicity determined by the investigator to be of no safety risk;
- Any uncontrolled active infection during the 4 weeks prior to apheresis that requires antibiotic, antiviral, or antifungal treatment;
- A history of active pulmonary tuberculosis infection within 1 year prior to anapheresis (except for subjects with a history of active pulmonary tuberculosis infection more than 1 year ago if the investigator determines that there is no evidence of active pulmonary tuberculosis at present);
- accompanied or prior history of interstitial lung disease or interstitial pneumonia; Patients with extensive lung metastasis or other severe lung disease whose lung function has been assessed by the investigator to be unable to tolerate treatment with the investigational drug;
- Have an active or past autoimmune disease that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis and psoriasis);
- Patients who required systemic corticosteroids (doses equal to or greater than 10 mg/ day) or other immunosuppressive drugs within 2 weeks of preapheresis or during the study period, except in the following cases: Intranasal, inhaled, local steroid or local steroid injection (Such as intra-articular injection), or systemic corticosteroid therapy not exceeding 10 mg/ day of prednisone or its physiological equivalent;
- Cardiovascular diseases of clinical significance#
- Insufficient bone marrow functional reserve or organ function#
- Bleeding events that have obvious clinical significance and require medical intervention occurred within 28 days prior to anapheresis; There was a significantly increased risk of gastrointestinal bleeding during the study period as assessed by the investigators;
- Patients with poorly controlled pleural effusion, pericardial effusion or abdominal and pelvic effusion who were judged unsuitable for inclusion by the investigator;
- Had received live attenuated vaccine within 28 days prior to anapheresis, or planned to receive live attenuated vaccine during the study period#
- Patients with a history of mental disorders or substance abuse were unable to participate in the study#
- Pregnant or lactating female subjects;
- The investigator considers that other conditions of the subjects may affect their adherence to the protocol or are not suitable for participation in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 100000
- Not yet recruiting
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100000
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Pharmacokinetics, and Initial Efficacy of a GPC3-targeted Chimeric Antigen Receptor Autologous T Cell Injection (OriC902) in GPC3-positive Advanced Hepatocellular Carcinoma (HCC) Subjects
This is a Phase I clinical study evaluating the safety, pharmacokinetics, and initial efficacy of a GPC3-targeted chimeric antigen receptor autologous T cell injection (OriC902) in GPC3-positive advanced hepatocellular carcinoma (HCC) subjects
Read the detailed description
The study consists of two phases: dose escalation phase and extension phase. "Accelerated titration" and "traditional 3+3 design" were used for dose escalation in the dose escalation stage. In this study, "accelerated titration" was planned for dose escalation in the low-dose phase (1.0E6/Kg and 3.0E6/ Kg). Starting from the dose group of 6.0E6/Kg, dose escalation was carried out using the "traditional 3+3 design" rule. After the DLT observation and PK analysis of all subjects in each dose group is completed, the investigator will determine whether to increase to the next dose group based on the safety, efficacy (if any) and PK data obtained previously. A Safety Review Committee (SRC) meeting may be convened during the trial if DLT or special conditions in one dose group are found to warrant discussion by the investigator. The SRC will discuss and make decisions on the next dose group dose, maximum tolerated dose (MTD), different routes of administration (e.g., hepatic arterial perfusion, intravenous infusion), extended recommended dose (RDE), and dose grouping based on safety, initial efficacy (if any), and PK data. After the maximum tolerated dose (MTD) and extended recommended dose (RDE) have been determined, the dose extension phase will continue to observe at least 10 subjects in each dose group within the defined 1-2 extended recommended doses to further observe safety and antitumor activity.
- Conditions
- HCC
- Being tested
- OriC902
- Keywords
- GPC3, HCC, CART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OriC902Drug
Whole peripheral blood mononuclear cells are extracted from patients (or donors) through leukocyte separation, and then the required T cell subsets are isolated, which will become the basis for the subsequent preparation of CAR T cells
| Study group | Role | What they receive |
|---|---|---|
| OriC902 | Experimental | OriC902 injection, dosage is divided into 1E6/Kg, 3E6/ Kg, 6E6/Kg, 1E7/Kg Receives: Drug: OriC902 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD or biologically effective dose
SRC will select MTD or biologically effective dose
Measured: 1year
RP2D
SRC will select RP2D based on safety, initial efficacy (if any) and PK data
Measured: 1year
Incidence and severity of AE and SAE,
To evaluate the incidence and severity of AE and SAE
Measured: 2year
Secondary outcomes (3)
PK of OriC902
Blood was collected according to the collection point of the protocol to analyze PK parameters
Measured: 2year
Peripheral blood concentration of two antibodies(PD-L1&VEGF)
Peripheral blood samples were collected from each subject for analysis of serum CAR-T-activated and inflammatory cytokines, including peripheral blood anti-PD-L1 and anti-VEGFA antibodies
Measured: 2year
Evaluate initial efficacy of OriC902
Assessment according to RECIST 1.1
Measured: 3year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start24 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies 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
- Model description
- The study consists of two phases: dose escalation phase and extension phase. "Accelerated titration" and "traditional 3+3 design" were used for dose escalation in the dose escalation stage. In this study, "accelerated titration" was planned for dose escalation in the low-dose phase (1.0E6/Kg and 3.0E6/ Kg). Starting from the dose group of 6.0E6/Kg, dose escalation was carried out using the "traditional 3+3 design" rule. The study was divided into screening period, treatment period and follow-up period.
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- OriCell Therapeutics Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891742
- Sponsor's protocol ID
- OriC902-T1
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Subject data is confidential research information and can only be viewed by the participating investigator or associated personnel
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety, Pharmacokinetics, and Initial Efficacy of a GPC3-targeted Chimeric Antigen Receptor Autologous T Cell Injection (OriC902) in GPC3-positive Advanced Hepatocellular Carcinoma (HCC) Subjects
- ClinicalTrials.gov ID
- NCT06891742
- Acronym / sponsor ID
- OriC902-T1
- Conditions
- HCC
- Keywords
- GPC3, HCC, CART
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- OriCell Therapeutics Co., Ltd.
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 24 Mar 2025 (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 Phase I clinical study evaluating the safety, pharmacokinetics, and initial efficacy of a GPC3-targeted chimeric antigen receptor autologous T cell injection (OriC902) in GPC3-positive advanced hepatocellular carcinoma (HCC) subjects
Detailed description
The study consists of two phases: dose escalation phase and extension phase. "Accelerated titration" and "traditional 3+3 design" were used for dose escalation in the dose escalation stage. In this study, "accelerated titration" was planned for dose escalation in the low-dose phase (1.0E6/Kg and 3.0E6/ Kg). Starting from the dose group of 6.0E6/Kg, dose escalation was carried out using the "traditional 3+3 design" rule. After the DLT observation and PK analysis of all subjects in each dose group is completed, the investigator will determine whether to increase to the next dose group based on the safety, efficacy (if any) and PK data obtained previously. A Safety Review Committee (SRC) meeting may be convened during the trial if DLT or special conditions in one dose group are found to warrant discussion by the investigator. The SRC will discuss and make decisions on the next dose group dose, maximum tolerated dose (MTD), different routes of administration (e.g., hepatic arterial perfusion, intravenous infusion), extended recommended dose (RDE), and dose grouping based on safety, initial efficacy (if any), and PK data. After the maximum tolerated dose (MTD) and extended recommended dose (RDE) have been determined, the dose extension phase will continue to observe at least 10 subjects in each dose group within the defined 1-2 extended recommended doses to further observe safety and antitumor activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study consists of two phases: dose escalation phase and extension phase. "Accelerated titration" and "traditional 3+3 design" were used for dose escalation in the dose escalation stage. In this study, "accelerated titration" was planned for dose escalation in the low-dose phase (1.0E6/Kg and 3.0E6/ Kg). Starting from the dose group of 6.0E6/Kg, dose escalation was carried out using the "traditional 3+3 design" rule. The study was divided into screening period, treatment period and follow-up period.
| Arm | Type | Receives |
|---|---|---|
| OriC902 | Experimental | Drug: OriC902OriC902 injection, dosage is divided into 1E6/Kg, 3E6/ Kg, 6E6/Kg, 1E7/Kg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Understand and voluntarily sign an informed consent form (ICF) prior to conducting any assessment/procedure related to the study;
- Ages 18 to 75 at the time of signing the ICF (including 18 and 75);
- HCC was diagnosed according to the Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 edition);
- Samples of liver tumor tissue or extrahepatic metastases within 1 year of signing the pre-screening informed consent were 1+ or more positive by immunohistochemical detection of GPC3 in tumor cells of at least 5% (dose escalation phase) or 10% (dose expansion phase);
- BCLC stage B HCC or BCLC stage C HCC that are not suitable for local therapy or relapse after local therapy and cannot be cured;
Key exclusion criteria (24 listed)
- Central nervous system (CNS) metastasis, meningeal metastasis, or spinal cord compression;#
- Have a history of allogeneic hematopoietic stem cell transplantation or organ transplantation;
- A history of other primary malignancies within 3 years prior to study treatment, except for the following: Adequate treatment of cured carcinoma in situ (including but not limited to cervical carcinoma in situ, breast carcinoma in situ, etc.); Adequate treatment of cured localized basal cell or squamous cell carcinoma of the skin;
- Hepatitis B surface antigen (HBsAg) positive or Hepatitis B core antibody (HBcAb) positive, and HBV-DNA > 500 IU/mL. (For HBsAg positive or HBCAB-positive patients, antiviral therapy should be performed for at least 4 weeks before the first administration of the study drug, and antiviral therapy should be continued during the study);
- Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Syphilis specific antibody positive and syphilis non-specific antibody positive; Cytomegalovirus (CMV) DNA test positive, EBV-DNA test positive;
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 |
|---|---|---|
| OriC902Whole peripheral blood mononuclear cells are extracted from patients (or donors) through leukocyte separation, and then the required T cell subsets are isolated, which will become the basis for the subsequent preparation of CAR T cells | Drug | OriC902 |
Primary outcome
MTD or biologically effective dose
Time frame: 1year
SRC will select MTD or biologically effective dose
RP2D
Time frame: 1year
SRC will select RP2D based on safety, initial efficacy (if any) and PK data
Incidence and severity of AE and SAE,
Time frame: 2year
To evaluate the incidence and severity of AE and SAE
3 secondary outcomes
PK of OriC902
Time frame: 2year
Peripheral blood concentration of two antibodies(PD-L1&VEGF)
Time frame: 2year
Evaluate initial efficacy of OriC902
Time frame: 3year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No. Subject data is confidential research information and can only be viewed by the participating investigator or associated personnel
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OriC902 in people with HCC, run by Peking University at 2 sites 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 24 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: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Changsong Qi (13811394004, xiwangpku@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD or biologically effective dose (time frame: 1year). The study lists 3 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 24 Mar 2025.