Liver CarcinomaPhase 1NCT06144385
A Phase 1, Single-arm, Open-label, Dose-escalation Study of JWATM204 as T Cell-targeted Immunotherapy in the Treatment Amongst Subjects With Advanced Hepatocellular Carcinoma
A Phase 1 study testing CAR-GPC3 T cells in people with Liver Carcinoma and Hepatic Cell Carcinoma, run by Shanghai Ming Ju Biotechnology Co., Ltd. at 1 site in China.
Trial summary
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infused autologous GPC3-directed CAR-T in patients with advanced hepatocellular carcinoma refractory to prior systematic treatments. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Carcinoma, Hepatic Cell Carcinoma
- What is being tested?
- CAR-GPC3 T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2022to Dec 2024
- 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
- 18-75 years-old, male or female
- Voluntarily willing to participate in the study and sign the written informed consent form
- Life expectation ≥12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status scale ≤1
- Histologically-confirmed hepatocellular carcinoma (HCC)
- No benefits from curative surgery or other local therapies are expected at screening, judged by investigators
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- Radiologically-confirmed progression disease after at least one prior line of systematic treatment and limited benefits from current available options for hepatocellular carcinoma are expected at screening, judged by investigators
- Fresh samples or formalin-fixed paraffin-embedded (FFPE) samples, immunohistochemistry (IHC)-stained GPC-3 positive
- Per RECIST v1.1, at least one measurable lesion
- Barcelona Clinic Liver Cancer (BCLC) stage C or B and Child-Pugh ≤7
- No active infections of hepatitis B virus
- Adequate organ functions
- Adequate venous access for apheresis
- Non-hematological AEs induced by previous treatment must have recovered to CTCAE ≤1, except for alopecia and peripheral neuropathy
- Women of childbearing potential must agree to use an effective and reliable contraceptive method during 28 days prior to lymphodepletion to 1 year post infusion; Male patients who have not undergone vasectomy and have sexual activity with women of childbearing potential must agree to the use of a barrier contraceptive method since lymphodepletion to 1year post infusion, and sperm donation is prohibited during the study
- Women of childbearing potential must have negative serum β-human chorionic gonadotropin (β-hCG) test result at screening and 48 hours prior to lymphodepletion
Who cannot join
- Active brain metastasis
- Primary lesion or infused lesions with the longest diameter ≥15 cm, or other potential risk which might not be appropriate for further study treatment judged by the investigator
- Another primary malignancy within 3 years (with some exceptions for completely-resected early-stage tumors)
- Systematic autoimmune disorders requiring long-term systematic immunosuppression
- Previously treated with any genetically engineered modified T-cell therapy nor other cell-gene therapy
- Active infections of hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis
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- Uncontrolled or active infection at screening, prior to apheresis, 72 hours prior to lymphodepletion or 5 days prior to JWATM204 infusion
- With severe cardiovascular disease History or presence of clinically-relevant central nervous system (CNS) disorders
- With clinically-significant CNS disorders
- Current presence of or previously with hepatic encephalopathy
- ≥G2 hemorrhage within 30 days prior to screening, or in need of long-term anticoagulants
- Pregnant or lactating women
- Not satisfying pre-defined wash-out period for apheresis
- Received plasma exchange within 14 days prior to apheresis
- Unable or unwilling to comply with the study protocol, judged by the investigator, or other situations implying that the subject might not be appropriate to participate in the study
- Vaccinated with live vaccinations against infectious diseases within 8 weeks prior to JWATM204 infusion
- Previously allergic or intolerable to JWATM204 or its components
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tao Zhang
Wuhan, Hubei, 430022
Tao Zhang, MD, PhD
Tao Zhang, MD, PhD
About this study
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infused autologous GPC3-directed CAR-T in patients with advanced hepatocellular carcinoma refractory to prior systematic treatments.
- Conditions
- Liver Carcinoma, Hepatic Cell Carcinoma
- Being tested
- CAR-GPC3 T cells
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-GPC3 T cellsBiological
Also called JWCAR204
Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWATM204 . During JWATM204 production, subjects will receive a preconditioning chemotherapy regimen of cyclophosphamide and fludarabine to deplete the lymphocytes. After lymphodepletion, subjects will receive single-dose treatment with JWATM204 by intravenous (IV) injection.
| Study group | Role | What they receive |
|---|---|---|
| CAR-GPC3 T cells | Experimental | The safety and efficacy of JWATM204 will be evaluated in a Bayesian Optimal Interval Design (BOIN) dose escalation approach. 3 CAR-T dose levels will be tested in this study: 1×10^8, 3×10^8, 10×10^8, and 30×10^8 CAR-T cells will be explored. Receives: Biological: CAR-GPC3 T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of dose-limiting toxicities (DLTs)
Dose-limiting toxicity (DLT) is defined as an adverse event that occurred within 28 days after JWATM204 infusion that met any of the following criteria. Any grade ≥3 nonhematologic toxicity associated with JWATM204 that has not resolved to ≤ grade 2 within 7 days, excluding clinically insignificant abnormalities in laboratory indicators Hematologic toxicity Grade ≥3 anaphylaxis Grade ≥3 infection did not resolve to grade ≤2 within 7 days after anti-infective treatment. ≥ grade 3 autoimmune toxicity during treatment Grade ≥3 cytokine release syndrome (CRS) during treatment that did not resolve to grade ≤2 within 72 hours. Grade ≥3 CAR-T cell-associated encephalopathy syndrome/immune effector cell-associated neurotoxicity syndrome (CRES/ICANS) that did not resolve to grade ≤2 within 72 hours. Grade 5 events of any nonmalignant cause.
Measured: 28 days
Rate and severity of adverse events (AEs) and severe adverse events (SAEs)
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Measured: 2 years
Rate and severity of clinically-significant abnormalities in laboratory testings
Clinically-significant abnormalities in laboratory testings.
Measured: 2 years
Secondary outcomes (5)
Copy number of the vector transgene of JWATM204 in peripheral blood
The pharmacokinetic parameters of JWATM204 will be evaluated by quantitative polymerase chain reaction (qPCR) for the copy number of the vector transgene of JWATM204 in peripheral blood to evaluate T-cell expansion and persistence.
Measured: 1 year
Objective response rate (ORR)
Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.
Measured: 2 years
Disease Control Rate (DCR)
The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents.
Measured: 2 years
Progression-free survival (PFS)
Defined as time from randomisation to first progression by investigator assessment using revised Response Evaluation Criteria in Solid Tumours (RECIST) guidelines (version 1.1) or death (by any cause in the absence of progression)
Measured: 2 years
Overal survival (OS)
Defined as the time from randomisation to death due to any cause.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start24 Mar 2022
- Primary completionMar 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CarcinomaStudies of the same condition, open and under way.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tao Zhang, MD, PhD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144385
- Sponsor's protocol ID
- JWATM204001
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang Y, Tang J, Wu Z, Zhang J, Liu D, Fan J, Wu G, Zhang T, Xue J. Safety and efficacy of JWATM204, a novel Glypican-3 (GPC3)-targeted CAR T cell therapy for advanced hepatocellular carcinoma: A phase I dose-escalation study. Cancer Pathog Ther. 2025 Dec 19;4(4):297-309. doi: 10.1016/j.cpt.2025.12.002. eCollection 2026 Jul.
PubMed 41859477
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-arm, Open-label, Dose-escalation Study of JWATM204 as T Cell-targeted Immunotherapy in the Treatment Amongst Subjects With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06144385
- Acronym / sponsor ID
- JWATM204001
- Conditions
- Liver Carcinoma, Hepatic Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 Nov 2023 (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 arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infused autologous GPC3-directed CAR-T in patients with advanced hepatocellular carcinoma refractory to prior systematic treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-GPC3 T cells | Experimental | Biological: CAR-GPC3 T cellsThe safety and efficacy of JWATM204 will be evaluated in a Bayesian Optimal Interval Design (BOIN) dose escalation approach. 3 CAR-T dose levels will be tested in this study: 1×10^8, 3×10^8, 10×10^8, and 30×10^8 CAR-T cells will be explored. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 18-75 years-old, male or female
- Voluntarily willing to participate in the study and sign the written informed consent form
- Life expectation ≥12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status scale ≤1
- Histologically-confirmed hepatocellular carcinoma (HCC)
Key exclusion criteria (17 listed)
- Active brain metastasis
- Primary lesion or infused lesions with the longest diameter ≥15 cm, or other potential risk which might not be appropriate for further study treatment judged by the investigator
- Another primary malignancy within 3 years (with some exceptions for completely-resected early-stage tumors)
- Systematic autoimmune disorders requiring long-term systematic immunosuppression
- Previously treated with any genetically engineered modified T-cell therapy nor other cell-gene therapy
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 |
|---|---|---|
| CAR-GPC3 T cellsAlso: JWCAR204Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWATM204 . During JWATM204 production, subjects will receive a preconditioning chemotherapy regimen of cyclophosphamide and fludarabine to deplete the lymphocytes. After lymphodepletion, subjects will receive single-dose treatment with JWATM204 by intravenous (IV) injection. | Biological | CAR-GPC3 T cells |
Primary outcome
Rate of dose-limiting toxicities (DLTs)
Time frame: 28 days
Dose-limiting toxicity (DLT) is defined as an adverse event that occurred within 28 days after JWATM204 infusion that met any of the following criteria. Any grade ≥3 nonhematologic toxicity associated with JWATM204 that has not resolved to ≤ grade 2 within 7 days, excluding clinically insignificant abnormalities in laboratory indicators Hematologic toxicity Grade ≥3 anaphylaxis Grade ≥3 infection did not resolve to grade ≤2 within 7 days after anti-infective treatment. ≥ grade 3 autoimmune toxicity during treatment Grade ≥3 cytokine release syndrome (CRS) during treatment that did not resolve to grade ≤2 within 72 hours. Grade ≥3 CAR-T cell-associated encephalopathy syndrome/immune effector cell-associated neurotoxicity syndrome (CRES/ICANS) that did not resolve to grade ≤2 within 72 hours. Grade 5 events of any nonmalignant cause.
Rate and severity of adverse events (AEs) and severe adverse events (SAEs)
Time frame: 2 years
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Rate and severity of clinically-significant abnormalities in laboratory testings
Time frame: 2 years
Clinically-significant abnormalities in laboratory testings.
5 secondary outcomes
Copy number of the vector transgene of JWATM204 in peripheral blood
Time frame: 1 year
Objective response rate (ORR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Overal survival (OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Derived from this study: PubMed 41859477Yang Y, Tang J, Wu Z, Zhang J, Liu D, Fan J, Wu G, Zhang T, Xue J. Safety and efficacy of JWATM204, a novel Glypican-3 (GPC3)-targeted CAR T cell therapy for advanced hepatocellular carcinoma: A phase I dose-escalation study. Cancer Pathog Ther. 2025 Dec 19;4(4):297-309. doi: 10.1016/j.cpt.2025.12.002. eCollection 2026 Jul.
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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.
Tao Zhang, MD, PhD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 CAR-GPC3 T cells in people with Liver Carcinoma and Hepatic Cell Carcinoma, run by Shanghai Ming Ju Biotechnology Co., Ltd. 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 16 inclusion and 17 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 2 Jan 2024. 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 Tao Zhang, MD, PhD (+86 027-85726375, 1277577866@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of dose-limiting toxicities (DLTs) (time frame: 28 days). 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?
On the ClinicalTrials.gov record for NCT06144385, which also lists 1 linked publication.
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 2 Jan 2024.