Hepatocellular Carcinoma (HCC)Early Phase 1SN301ANCT06652243
Clinical Study of SN301A Injection in the Treatment of Hepatocellular Carcinoma
A Early Phase 1 study testing SN301A in people with Hepatocellular Carcinoma (HCC), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This is a single-arm, open-label study of safety, tolerability, and anti-cancer activity of SN301A (an off-the-shelf CAR NK cell therapy) in patients with glypican-3 (GPC3)-positive advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- SN301A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2024to 31 Oct 2027
- Phase
- Early 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent (ICF) and capable of complying with protocol-specified visits and related procedures;
- Age ≥ 18 years and ≤ 70 years, male or female;
- According to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer of CSCO in 2024, hepatocellular carcinoma was Diagnosed and GPC3 expression was positive by immunohistochemistry (GPC3 positive was defined as staining positive i.e. ≥ 2 + as defined by Kaseb et al);
- Barcelona Clinic Liver Cancer (BCLC) stage determined to be unresectable Stage B or C hepatocellular carcinoma, including: disease progression following surgical/local therapy or unsuitable for surgical/local therapy, recurrent or metastatic HCC;
- Failed at least one prior line of systemic therapy and had used PD-1/L1 and /or TKIs;
- Child-Pugh A or B 7 points and no history of hepatic encephalopathy;
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- ECOG score 0-1;
- Life expectancy of no less than 12 weeks;
- Subjects with at least 1 measurable lesion according to RECIST v1.1 and mRECIST (a lesion that has undergone local therapy such as radiation therapy or interventional therapy cannot be considered measurable unless imaging evidence confirms unequivocal progression of the lesion), RECIST v1.1 i.e., non-nodal lesions ≥ 10 mm in longest diameter and/or nodal lesions ≥ 15 mm in short diameter on CT or MRI; mRECIST refers to non-lymph node measurable disease criteria meeting RECIST v1.1 criteria (hilar lymph nodes must have short axis ≥ 20 mm) and demonstrating intratumoral arterial enhancement on contrast-enhanced CT or MRI ;
- Subjects must provide either fresh tumor tissue samples that meet the requirements or archival tissue within 2 year prior to signing the ICF;
- Subject has adequate organ and bone marrow function and meets the following laboratory criteria:
- Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5e9/L; platelets (PLT) ≥ 75e9/L (transfusion or use of hematopoietic stimulating factors was not acceptable within 14 days prior to Screening);
- Hemoglobin ≥ 90g/L;
- Liver function: total bilirubin ≤ 2.5 × ULN; alanine aminotransferase ≤ 5 × ULN; aspartate aminotransferase ≤ 5 × ULN;
- Renal function: serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula);
- Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (INR between 2.0 and 3.0 is required for subjects receiving prophylactic anticoagulant therapy);
- Men and women of childbearing potential must agree to use effective contraception from signing the ICF until one year after the last cell infusion and must have a negative serum pregnancy test at screening for women of childbearing potential.
Who cannot join
- Metastases to central nervous system, including brain metastases and/or meningeal metastases;
- Prior bone marrow or organ transplant (including but not limited to liver transplant) or waiting for transplant;
- Previous or concurrent history of other malignancies, except for carcinoma in situ of the uterine cervix that has been cured and has not recurred for at least 2 years before screening, noninvasive basal cell or squamous cell skin cancer, or ductal carcinoma in situ after radical treatment for localized prostate cancer and radical resection;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and HBV DNA > 500 IU/mL (lower limit of detection; HBV DNA ≤ 500 IU/mL, lymphodepletion pretreatment requires antiviral therapy for at least 14 days before treatment and can be enrolled if antiviral therapy is continued during the study); hepatitis C virus (HCV) antibody positive and HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody positive;
- HLA antibody positive subjects, including weak positive, positive and strong positive (except those with HLA typing different from SN301A cell injection products);
- Prior treatment with other cellular products or GPC3-targeted agents;
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- Received any fluoropyrimidine chemotherapeutic agents or small-molecule targeted agents within 14 days or 5 half-lives (whichever is shorter) prior to signing the ICF; received any antineoplastic biological agents or non-fluoropyrimidine chemotherapeutic agents within 28 days prior to signing the ICF; received wide-range radiotherapy within 28 days prior to signing the ICF, received local radiotherapy for non-target lesions to relieve symptoms within 14 days prior to signing the ICF; received traditional Chinese medicine/Chinese herbal medicine and local interventional therapy with anti-tumor indications within 14 days prior to signing the ICF;
- Adverse events resulting from prior anticancer therapy have not recovered to Grade 1 or baseline, except for alopecia, Grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement;
- Subjects who have received attenuated live vaccine immunization within 28 days prior to signing ICF or need to receive attenuated live vaccine immunization during the study;
- Major surgical treatment (except liver mass biopsy) within 28 days prior to signing the ICF, or the need for major surgical treatment during the study;
- Requiring chronic systemic corticosteroids (at doses ≥ 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days prior to the first study drug infusion or during the study, except for inhaled or topical use;
- Subjects with fungal, bacterial, viral, tuberculosis or other infection requiring systemic anti-infective treatment within 14 days prior to signing the ICF;
- Patients with active or previous autoimmune diseases that may recur, such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.;
- Previous or current interstitial lung disease, pneumonoultra microscopic pneumonitis, radiation pneumonitis, severely impaired pulmonary function, etc.;
- Third space effusion that is not clinically well controlled before screening, such as pleural effusion and ascites that cannot be controlled by drainage or other methods;
- History of serious cardiovascular and cerebrovascular diseases, including but not limited to in:
- Patients with severe heart rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, grade II-III atrioventricular block;
- QT interval corrected by Fridericias formula (QTcF) prolongation > 450 ms for males; > 470 ms for females;
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other ≥ Grade 3 cardiovascular or cerebrovascular event within 6 months prior to Screening;
- Presence of heart failure of New York Heart Association (NYHA) Functional Class ≥ II or left ventricular ejection fraction (LVEF) > 50%;
- Clinically uncontrolled hypertension, systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg.
- Patients with history of pulmonary embolism or severe lower extremity deep venous thrombosis requiring interventional treatment such as inferior vena cava filter implantation or therapeutic dose of anticoagulants at screening;
- Investigator assessment of intrahepatic tumor mass greater than 50% of the entire liver, or tumor thrombus invading major vessels such as the main portal vein, superior mesenteric vein, or inferior vena cava causing complications such as portal hypertension or associated clinical risks;
- Subject is participating in another interventional clinical study;
- Pregnant or lactating women;
- Subjects with other conditions that, in the opinion of the investigator, could affect compliance or unsuitability for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Qi Li, MD, 86-021-60524213, Leeqi2001@hotmail.com
Jingyi Zhou, MD, 86-021-60524213, jingyi_zhou9468@163.com
About this study
Official title: An Early Clinical Study to Evaluate the Safety and Efficacy of SN301A Cell Injection in the Treatment of Subjects with Glypican-3 (GPC3)-Positive Advanced Hepatocellular Carcinoma
This is a single-arm, open-label study of safety, tolerability, and anti-cancer activity of SN301A (an off-the-shelf CAR NK cell therapy) in patients with glypican-3 (GPC3)-positive advanced hepatocellular carcinoma.
Read the detailed description
This study is a single-arm, open-label, modified 3+3 dose-escalation early exploratory clinical study to evaluate the safety, tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) of SN301A cell injection in the treatment of subjects with glypican-3 (GPC3)-positive advanced hepatocellular carcinoma, and evaluate the efficacy of SN301A cell injection in the treatment of subjects with GPC3-positive advanced hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- SN301A
- Keywords
- hepatocellular carcinoma, CAR NK, GPC3
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SN301ABiological
Also called Fludarabine, Cyclophosphamide
SN301A is an investigational off-the-shelf CAR NK cell therapy, armed with calibrated release (cr)IL15, designed to selectively target and treat GPC3 expressing advanced hepatocellular carcinoma.
Subjects will receive lymphodepletion pretreatment (Fludarabine/Cyclophosphamide), three SN301A intravenous infusions in a cycle (D0, D7, D14), with each subject receiving a maximum of 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| SN301A CAR NK cell therapy | Experimental | Using the modified "3 + 3" design principle, a total of 3 dose groups are planned,.There were 1 case in the first group and 3 to 6 cases in each of the last two groups ： Dose level 1 (Initial safe dose): 0.5e9 CAR+ NK cells, Dose level 2 (Target effective dose): 1e9 CAR+ NK cells, Dose level 3（Maximum dose）: 2e9 CAR+ NK cells Which are administered once on Days 0, 7, and 14 of each 28 day cycle. Receives: Biological: SN301A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities
Incidence of DLT after the first infusion of SN301A cell injection
Measured: 28 days post SN301A infusion.
Incidence and severity of adverse events (AEs)and serious adverse events (SAEs) (Safety and Tolerability)
Any untoward medical event that occurs after a subject has administered an investigational product, which may be manifested as a symptom, sign, disease or laboratory abnormality but does not necessarily have a causal relationship with the investigational product.
Measured: Through study completion, up to 2 years
Secondary outcomes (13)
Objective response rate (ORR) after SN301A infusion
Efficacy results of SN301A
Measured: Through study completion, up to 2 years
Disease control rate (DCR) after SN301A infusion
Efficacy results of SN301A
Measured: Through study completion, up to 2 years
Duration of response (DOR) after SN301A infusion
Efficacy results of SN301A
Measured: Through study completion, up to 2 years
Progression-free survival (PFS) after SN301A infusion
Efficacy results of SN301A
Measured: Through study completion, up to 2 years
Overall survival (OS) after SN301A infusion
Efficacy results of SN301A
Measured: Through study completion, up to 2 years
Concentration of alpha fetoprotein (AFP) after SN301A infusion
Efficacy results of SN301A
Measured: Through study completion, up to 2 years
Concentration of abnormal prothrombin after SN301A infusion
Efficacy results of SN301A
Measured: Through study completion, up to 2 years
Concentration of carbohydrate antigen 19-9 after SN301A infusion
Efficacy results of SN301A
Measured: Through study completion, up to 2 years
PK parameters of CAR NK cells in peak peripheral blood (Cmax) after SN301A infusion
Pharmacokinetic (PK) results of SN301A
Measured: Through study completion, up to 2 years
PK parameters of CAR NK cells in time to peak peripheral blood (Tmax) after SN301A infusion
Pharmacokinetic (PK) results of SN301A
Measured: Through study completion, up to 2 years
PK parameters of CAR NK cells in half-life (t 1/2) after SN301A infusion
Pharmacokinetic (PK) results of SN301A
Measured: Through study completion, up to 2 years
PK parameters of CAR NK cells in area under the concentration versus time curve (AUC) after SN301A infusion
Pharmacokinetic (PK) results of SN301A
Measured: Through study completion, up to 2 years
Levels of cytokines (IL-6, IFN-γ, TNF-α, IL-15) in peripheral blood after SN301A infusion
Pharmacokinetic (PK) results of SN301A
Measured: Through study completion, up to 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 Oct 2024
- Study start18 Nov 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Celest Therapeutics (Shanghai) Co., Ltd., Senti Biosciences
- Responsible party
- Principal investigator, Qi Li, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652243
- Sponsor's protocol ID
- SN301A-001
- Acronym
- SN301A
- Status last verified
- Nov 2024
- First submitted
- 17 Oct 2024
- Last updated
- 25 Nov 2024
- 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 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Clinical Study to Evaluate the Safety and Efficacy of SN301A Cell Injection in the Treatment of Subjects with Glypican-3 (GPC3)-Positive Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06652243
- Acronym / sponsor ID
- SN301A / SN301A-001
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- hepatocellular carcinoma, CAR NK, GPC3
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Celest Therapeutics (Shanghai) Co., Ltd., Senti Biosciences
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 22 Oct 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.
This is a single-arm, open-label study of safety, tolerability, and anti-cancer activity of SN301A (an off-the-shelf CAR NK cell therapy) in patients with glypican-3 (GPC3)-positive advanced hepatocellular carcinoma.
Detailed description
This study is a single-arm, open-label, modified 3+3 dose-escalation early exploratory clinical study to evaluate the safety, tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) of SN301A cell injection in the treatment of subjects with glypican-3 (GPC3)-positive advanced hepatocellular carcinoma, and evaluate the efficacy of SN301A cell injection in the treatment of subjects with GPC3-positive 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 |
|---|---|---|
| SN301A CAR NK cell therapy | Experimental | Biological: SN301AUsing the modified "3 + 3" design principle, a total of 3 dose groups are planned,.There were 1 case in the first group and 3 to 6 cases in each of the last two groups ： Dose level 1 (Initial safe dose): 0.5e9 CAR+ NK cells, Dose level 2 (Target effective dose): 1e9 CAR+ NK cells, Dose level 3（Maximum dose）: 2e9 CAR+ NK cells Which are administered once on Days 0, 7, and 14 of each 28 day cycle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Signed written informed consent (ICF) and capable of complying with protocol-specified visits and related procedures;
- Age ≥ 18 years and ≤ 70 years, male or female;
- According to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer of CSCO in 2024, hepatocellular carcinoma was Diagnosed and GPC3 expression was positive by immunohistochemistry (GPC3 positive was defined as staining positive i.e. ≥ 2 + as defined by Kaseb et al);
- Barcelona Clinic Liver Cancer (BCLC) stage determined to be unresectable Stage B or C hepatocellular carcinoma, including: disease progression following surgical/local therapy or unsuitable for surgical/local therapy, recurrent or metastatic HCC;
- Failed at least one prior line of systemic therapy and had used PD-1/L1 and /or TKIs;
Key exclusion criteria (26 listed)
- Metastases to central nervous system, including brain metastases and/or meningeal metastases;
- Prior bone marrow or organ transplant (including but not limited to liver transplant) or waiting for transplant;
- Previous or concurrent history of other malignancies, except for carcinoma in situ of the uterine cervix that has been cured and has not recurred for at least 2 years before screening, noninvasive basal cell or squamous cell skin cancer, or ductal carcinoma in situ after radical treatment for localized prostate cancer and radical resection;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and HBV DNA > 500 IU/mL (lower limit of detection; HBV DNA ≤ 500 IU/mL, lymphodepletion pretreatment requires antiviral therapy for at least 14 days before treatment and can be enrolled if antiviral therapy is continued during the study); hepatitis C virus (HCV) antibody positive and HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody positive;
- HLA antibody positive subjects, including weak positive, positive and strong positive (except those with HLA typing different from SN301A cell injection products);
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 |
|---|---|---|
| SN301AAlso: Fludarabine, CyclophosphamideSN301A is an investigational off-the-shelf CAR NK cell therapy, armed with calibrated release (cr)IL15, designed to selectively target and treat GPC3 expressing advanced hepatocellular carcinoma. Subjects will receive lymphodepletion pretreatment (Fludarabine/Cyclophosphamide), three SN301A intravenous infusions in a cycle (D0, D7, D14), with each subject receiving a maximum of 3 cycles. | Biological | SN301A CAR NK cell therapy |
Primary outcome
Dose-limiting toxicities
Time frame: 28 days post SN301A infusion.
Incidence of DLT after the first infusion of SN301A cell injection
Incidence and severity of adverse events (AEs)and serious adverse events (SAEs) (Safety and Tolerability)
Time frame: Through study completion, up to 2 years
Any untoward medical event that occurs after a subject has administered an investigational product, which may be manifested as a symptom, sign, disease or laboratory abnormality but does not necessarily have a causal relationship with the investigational product.
13 secondary outcomes
Objective response rate (ORR) after SN301A infusion
Time frame: Through study completion, up to 2 years
Disease control rate (DCR) after SN301A infusion
Time frame: Through study completion, up to 2 years
Duration of response (DOR) after SN301A infusion
Time frame: Through study completion, up to 2 years
Progression-free survival (PFS) after SN301A infusion
Time frame: Through study completion, up to 2 years
Overall survival (OS) after SN301A infusion
Time frame: Through study completion, up to 2 years
Concentration of alpha fetoprotein (AFP) after SN301A infusion
Time frame: Through study completion, up to 2 years
Concentration of abnormal prothrombin after SN301A infusion
Time frame: Through study completion, up to 2 years
Concentration of carbohydrate antigen 19-9 after SN301A infusion
Time frame: Through study completion, up to 2 years
PK parameters of CAR NK cells in peak peripheral blood (Cmax) after SN301A infusion
Time frame: Through study completion, up to 2 years
PK parameters of CAR NK cells in time to peak peripheral blood (Tmax) after SN301A infusion
Time frame: Through study completion, up to 2 years
PK parameters of CAR NK cells in half-life (t 1/2) after SN301A infusion
Time frame: Through study completion, up to 2 years
PK parameters of CAR NK cells in area under the concentration versus time curve (AUC) after SN301A infusion
Time frame: Through study completion, up to 2 years
Levels of cytokines (IL-6, IFN-γ, TNF-α, IL-15) in peripheral blood after SN301A infusion
Time frame: Through study completion, up to 2 years
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 25 Nov 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SN301A in people with Hepatocellular Carcinoma (HCC), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 17 inclusion and 26 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 25 Nov 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Li, MD (86-021-60524213, Leeqi2001@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (time frame: 28 days post SN301A infusion.). The study lists 2 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 25 Nov 2024.