OncoMatch/Clinical Trials/NCT06652243
Clinical Study of SN301A Injection in the Treatment of Hepatocellular Carcinoma
Is NCT06652243 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies SN301A for hepatocellular carcinoma (hcc).
Treatment: SN301A — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Biomarker criteria
Required: GPC3 overexpression (staining positive i.e. ≥ 2+ as defined by Kaseb et al)
GPC3 expression was positive by immunohistochemistry (GPC3 positive was defined as staining positive i.e. ≥ 2 + as defined by Kaseb et al)
Excluded: HLA antibody positive
HLA antibody positive subjects, including weak positive, positive and strong positive (except those with HLA typing different from SN301A cell injection products)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy
Failed at least one prior line of systemic therapy
Must have received: PD-1/PD-L1 inhibitor or tyrosine kinase inhibitor
had used PD-1/L1 and /or TKIs
Cannot have received: bone marrow or organ transplant
Prior bone marrow or organ transplant (including but not limited to liver transplant) or waiting for transplant
Cannot have received: cellular products
Prior treatment with other cellular products
Cannot have received: GPC3-targeted agents
Prior treatment with...GPC3-targeted agents
Cannot have received: fluoropyrimidine chemotherapeutic agents or small-molecule 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
Cannot have received: antineoplastic biological agents or non-fluoropyrimidine chemotherapeutic agents
received any antineoplastic biological agents or non-fluoropyrimidine chemotherapeutic agents within 28 days prior to signing the ICF
Cannot have received: wide-range radiotherapy
received wide-range radiotherapy within 28 days prior to signing the ICF
Cannot have received: local radiotherapy for non-target lesions
received local radiotherapy for non-target lesions to relieve symptoms within 14 days prior to signing the ICF
Cannot have received: traditional Chinese medicine/Chinese herbal medicine and local interventional therapy with anti-tumor indications
received traditional Chinese medicine/Chinese herbal medicine and local interventional therapy with anti-tumor indications within 14 days prior to signing the ICF
Lab requirements
Blood counts
ANC ≥ 1.5e9/L; platelets ≥ 75e9/L (no transfusion or hematopoietic stimulating factors within 14 days prior to Screening); hemoglobin ≥ 90g/L
Kidney function
serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula)
Liver function
total bilirubin ≤ 2.5 × ULN; alanine aminotransferase ≤ 5 × ULN; aspartate aminotransferase ≤ 5 × ULN; Child-Pugh A or B 7 points and no history of hepatic encephalopathy
Cardiac function
QTcF ≤ 450 ms for males; ≤ 470 ms for females; no severe heart rhythm or conduction abnormalities; no acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other ≥ Grade 3 cardiovascular/cerebrovascular event within 6 months; NYHA Functional Class < II; LVEF > 50%; no uncontrolled hypertension (SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg)
adequate organ and bone marrow function and meets the following laboratory criteria: ... see full criteria above
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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