BridgeMD
New treatment option for Hepatocellular Carcinoma (HCC)
Official title Clinical Study of SN301A Injection in the Treatment of Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT06652243
What this study is testing
What is SN301A?
SN301A is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma (hcc).
Also referred to as Fludarabine, Cyclophosphamide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Barcelona Clinic Liver Cancer (BCLC) stage determined to be unresectable Stage B or C hepatocellular carcinoma, including: disease progression...
- Failed at least one prior line of systemic therapy and had used PD-1/L1 and /or TKIs;
You likely can't join if
- 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...
- 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...
- HLA antibody positive people, including weak positive, positive and strong positive (except those with HLA typing different from SN301A cell...
- Prior treatment with other cellular products or GPC3-targeted agents;
See the full eligibility criteria
Who can 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...
- 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...
- 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;
- ECOG score 0-1;
- Life expectancy of no less than 12 weeks;
- people 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 treatment therapy cannot be considered measurable unless imaging...
- people 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 people 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...
What rules you out
- 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...
- 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...
- HLA antibody positive people, 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;
- 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...
- 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;
- people 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...
- people 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 treatment treatment such as inferior vena cava filter implantation or therapeutic dose of anticoagulants at...
- 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...
- Subject is participating in another treatment clinical study;
- Pregnant or lactating women;
- people with other conditions that, in the opinion of the investigator, could affect compliance or unsuitability for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.