Advanced Hepatocellular CarcinomaPhase 1NCT06676982
Clinical Trial of Autologous CD19 CAR-T Cells (CNCT19) Therapy for Advanced Hepatocellular Carcinoma
A Phase 1 study testing anti-CD19 CAR-T in people with Advanced Hepatocellular Carcinoma, run by Zhejiang University at 2 sites in China.
Trial summary
A phase I clinical study of the safety and tolerability, efficacy of CNCT19 CAR T-cell therapy in patients with advanced hepatocellular carcinoma hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- anti-CD19 CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesChina
- Study dates
- 10 Jan 2025to 31 Aug 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years, male or female;
- Subjects voluntarily participated in the research and signed the Informed Consent Form (ICF) by themselves or their guardians;
- Pathologically diagnosed with hepatocellular carcinoma, patients with China liver Cancer Staging (CNLC) stageII-III.;
- HCC patients who are not suitable for surgical resection or local treatment (including ablation therapy, interventional therapy, and radiation therapy), or who experience recurrence or progression after surgery and/or local treatment, and who have previously received at least second-line systematic standardized treatment and have progressed or are intolerant to it;
- According to RECIST 1.1 standard, there should be at least one measurable tumor lesion;
- Tumor samples that meet the requirements (paraffin blocks or unstained sections with a quantity that meets the testing requirements specified in this study) within 2 years, and have CD19/CD68 double positive cells detected by immunohistochemistry or immunofluorescence;
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- Child-Pugh ≤ 7 and no history of hepatic encephalopathy;
- ECOG 0-1;
- Expected survival period ≥ 12 weeks;
- The toxicity caused by previous treatment has stabilized or recovered to ≤ level 1 (except for cases judged by the researcher to be clinically insignificant)
Who cannot join
- Active brain metastasis;
- Patients who have received or are waiting for organ transplantation;
- Active autoimmune diseases that require systemic immunosuppressive therapy within the past 2 years, such as systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, etc;
- Researchers evaluated that the proportion of intrahepatic tumors is greater than 50% of the entire liver; Or there may be tumor thrombus formation in the main portal vein, or tumor thrombus invasion into the mesenteric vein/inferior vena cava;
- Use any of the following drugs or treatment methods within the specified time before cell collection: a Received local treatments such as surgical intervention, radiation therapy, ablation, etc. for the studied disease within 4 weeks prior to cell collection; b. Patients who have undergone major surgical procedures or significant trauma within 4 weeks prior to cell collection, or who are expected to undergo major surgery during the study period; c. Received immunotherapy such as anti-PD-1 and PD-L1 within one week prior to cell collection; d. Received chemotherapy drugs or targeted therapy such as sorafenib, regorafenib, lenvatinib within 2 weeks prior to cell collection; e. Used therapeutic doses of corticosteroids within 3 days prior to cell collection, but allowed to use topical and inhaled corticosteroids;
- Within the past 5 years or simultaneously with other incurable malignant tumors, except for cervical cancer in situ, basal cell carcinoma of the skin, and ductal carcinoma in situ of the breast;
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- Individuals who have received other cell therapies or gene modified cell therapies in the past;
- Central nervous system diseases that have clinical significance in the past or screening, such as epilepsy, epileptic seizures, cerebrovascular disease (ischemia/hemorrhage/cerebral infarction), cerebral edema, reversible posterior white matter encephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychiatric disorders;
- There are chronic obstructive pulmonary disease, interstitial lung disease, and clinically significant abnormalities in lung function tests;
- After evaluation by the researchers, it was found that the subject had a large amount of uncontrollable serous fluid accumulation (such as pleural effusion, abdominal effusion, pericardial effusion).
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
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Qi Zhang, Professor, 0571-87233418, qi.zhang@zju.edu.cn
Tingbo Liang, Professor
- Not yet recruiting
First Affiliated Hospital, Medical College of Zhejiang University
Hangzhou, Zhejiang, 310003
Tingbo Liang, MD,PHD, 086-571-87236688, liangtingbo@zju.edu.cn
Tingbo Liang, Professor
About this study
A phase I clinical study of the safety and tolerability, efficacy of CNCT19 CAR T-cell therapy in patients with advanced hepatocellular carcinoma hepatocellular carcinoma.
Read the detailed description
This is a single-arm, dose-escalation, open, exploratory clinical study to evaluate the safety and tolerability, preliminary efficacy and PK/PD haracteristics of CNCT19 CAR T-cell therapy in the treatment of advanced hepatocellular carcinoma.
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- anti-CD19 CAR-T
- Keywords
- Advanced Hepatocellular Carcinoma, CAR-T, CD19, Tumor-associated macrophage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19 CAR-TBiological
All subjects were intravenous administrated with CNCT19 CAR-T.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | CNCT19 Receives: Biological: anti-CD19 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Describe the adverse events of limiting further increases in the dose of CNCT19.
Measured: Within 28 days of CNCT19infusion
Adverse events
Describe adverse events (AEs) and serious adverse events (SAEs) that are "likely" or "definitely" related to the studytreatment that occur at any time of 24 months after treatment.
Measured: Within 24 months after the treatment
Maximum tolerated dose
Determine the optimal agent for CNCT19 at maximum tolerated dose.
Measured: From enrollment of the first subject to completion of follow-up of the last subject (up to 3 years)
Secondary outcomes (7)
Effectiveness evaluation
Objective response rate by RECIST 1.1.
Measured: From treatment of the first subject to completion of follow-up of the last subject (up to 3 years)
Effectiveness evaluation
Progression-free survival by RECIST 1.1
Measured: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Effectiveness evaluation
Duration of response by RECIST 1.1
Measured: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Effectiveness evaluation
Time to response by RECIST 1.1
Measured: From enrollment of the first subject to completion of follow-up of the last subject (up to 3 years)
Effectiveness evaluation
Disease control time by RECIST 1.1
Measured: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Pharmacokinetic evaluation
Detect duration of CAR-T cells in vivo.
Measured: Within 28 days of CNCT19 infusion
Pharmacokinetic evaluation
Detect expansion of CAR-T cells in vivo.
Measured: Within 28 days of CNCT19 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start10 Jan 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion31 Aug 2026 (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 Zhejiang 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Juventas Cell Therapy Ltd.
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
- Investigators
- Tingbo Liang, Professor, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676982
- Sponsor's protocol ID
- HY001017
- Status last verified
- Dec 2025
- First submitted
- 5 Nov 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Autologous CD19 CAR-T Cells (CNCT19) Therapy for Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06676982
- Acronym / sponsor ID
- HY001017
- Conditions
- Advanced Hepatocellular Carcinoma
- Keywords
- Advanced Hepatocellular Carcinoma, CAR-T, CD19, Tumor-associated macrophage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Juventas Cell Therapy Ltd.
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 6 Nov 2024 (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 the safety and tolerability, efficacy of CNCT19 CAR T-cell therapy in patients with advanced hepatocellular carcinoma hepatocellular carcinoma.
Detailed description
This is a single-arm, dose-escalation, open, exploratory clinical study to evaluate the safety and tolerability, preliminary efficacy and PK/PD haracteristics of CNCT19 CAR T-cell therapy in the treatment of advanced hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Biological: anti-CD19 CAR-TCNCT19 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 to 80 years, male or female;
- Subjects voluntarily participated in the research and signed the Informed Consent Form (ICF) by themselves or their guardians;
- Pathologically diagnosed with hepatocellular carcinoma, patients with China liver Cancer Staging (CNLC) stageII-III.;
- HCC patients who are not suitable for surgical resection or local treatment (including ablation therapy, interventional therapy, and radiation therapy), or who experience recurrence or progression after surgery and/or local treatment, and who have previously received at least second-line systematic standardized treatment and have progressed or are intolerant to it;
- According to RECIST 1.1 standard, there should be at least one measurable tumor lesion;
Key exclusion criteria (10 listed)
- Active brain metastasis;
- Patients who have received or are waiting for organ transplantation;
- Active autoimmune diseases that require systemic immunosuppressive therapy within the past 2 years, such as systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, etc;
- Researchers evaluated that the proportion of intrahepatic tumors is greater than 50% of the entire liver; Or there may be tumor thrombus formation in the main portal vein, or tumor thrombus invasion into the mesenteric vein/inferior vena cava;
- Use any of the following drugs or treatment methods within the specified time before cell collection: a Received local treatments such as surgical intervention, radiation therapy, ablation, etc. for the studied disease within 4 weeks prior to cell collection; b. Patients who have undergone major surgical procedures or significant trauma within 4 weeks prior to cell collection, or who are expected to undergo major surgery during the study period; c. Received immunotherapy such as anti-PD-1 and PD-L1 within one week prior to cell collection; d. Received chemotherapy drugs or targeted therapy such as sorafenib, regorafenib, lenvatinib within 2 weeks prior to cell collection; e. Used therapeutic doses of corticosteroids within 3 days prior to cell collection, but allowed to use topical and inhaled corticosteroids;
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 |
|---|---|---|
| anti-CD19 CAR-TAll subjects were intravenous administrated with CNCT19 CAR-T. | Biological | Treatment group |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: Within 28 days of CNCT19infusion
Describe the adverse events of limiting further increases in the dose of CNCT19.
Adverse events
Time frame: Within 24 months after the treatment
Describe adverse events (AEs) and serious adverse events (SAEs) that are "likely" or "definitely" related to the studytreatment that occur at any time of 24 months after treatment.
Maximum tolerated dose
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 3 years)
Determine the optimal agent for CNCT19 at maximum tolerated dose.
7 secondary outcomes
Effectiveness evaluation
Time frame: From treatment of the first subject to completion of follow-up of the last subject (up to 3 years)
Effectiveness evaluation
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Effectiveness evaluation
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Effectiveness evaluation
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 3 years)
Effectiveness evaluation
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Pharmacokinetic evaluation
Time frame: Within 28 days of CNCT19 infusion
Pharmacokinetic evaluation
Time frame: Within 28 days of CNCT19 infusion
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 15 Dec 2025.
- 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.
Tingbo Liang, Professor principal investigator
First Affiliated Hospital of Zhejiang University
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 anti-CD19 CAR-T in people with Advanced Hepatocellular Carcinoma, run by Zhejiang 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 10 inclusion and 10 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 15 Dec 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 Qi Zhang (Associate professor ext. 13819137113, qi.zhang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: Within 28 days of CNCT19infusion). 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 15 Dec 2025.