Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06652243 | Clinical Study of SN301A Injection in the Treatment of Hepatocellular Carcinoma | EARLY_PHASE1 | RECRUITING | 12 | — | — | Nov 18, 2024 | Oct 31, 2027 | Nov 25, 2024 | 1 | China |
Incidence of DLT after the first infusion of SN301A cell injection
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| SN301A | BIOLOGICAL | 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. |
Inclusion Criteria: 1. Signed written informed consent (ICF) and capable of complying with protocol-specified visits and related procedures; 2. Age ≥ 18 years and ≤ 70 years, male or female; 3. According to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer of CSCO in 2024, hepa...