Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing Immupeutics Medicine Technology Limited | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
In this study, safety and effects of IPM001 injection on human hepatocellular carcinoma are going to be investigated, IPM001 is a multiple tumor-associated antigen (TAA) and neoantigen/tumor-specific antigen (TSA) sensitized autoimmune cell injection
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPM001 | Experimental | A neoantigen/ tumor-specific antigen sencitized autoimmune cell injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPM001 | Biological | IPM001 will be used against tumor cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| safety (AE/ irAE/ SAE) | Adverse events, Immue-related adverse,serious adverse event | 12 months |
| Tolerance(DLT/ MTD/ OBD) | Dose Limiting Toxicity, Maximum Tolerated Dose, Optimal Biological Dose | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | The time between the NeoAg/aeTSA CTL initiation and the onset of tumor progress or death from any cause | 12 months |
| Overall Survival (OS) | From the beginning of NeoAg/aeTSA CTL initiation to the time of death from any cause |
Not provided
Inclusion Criteria:
Subjects who understand and voluntarily sign the informed consent forms;
Subjects aged 18-75 years old (inclusive), male or female;
Subjects with progressive hepatocellular carcinoma who failed second-line therapy;
Subjects with an expected survival ≥ 6 months;
Subjects with a Child-Pugh score ≤ 7;
Subjects with an HLA A-02 genotype;
Subjects with a TBS score < 8;
Subjects with an ECOG score of 0-2 (inclusive);
Male and female subjects of childbearing potential must agree to use highly effective contraceptive methods during the entire study and for at least 3 months after receiving the last treatment, and women of childbearing age must have a negative pregnancy test;
Weight: Male > 50 kg, female > 45 kg;
Subjects with liver tumor lesions that can be used for tumor tissue biopsy. If feasible, the subjects must agree to provide tumor tissue specimens at baseline;
Subjects with no major organ dysfunctions (by laboratory test): ①white blood cell count ≥ 3.0 × 109/L; ② neutrophil count ≥ 1.5 × 109/L; ③ hemoglobin ≥ 90 g/L; ④ platelet count ≥ 30 × 109/L; ⑤ total bilirubin ≤ 2 × ULN; ⑥ Serum AST (GOT) and ALT (GPT) ≤ 2.5 × ULN; ⑦ albumin ≥ 3.0 g/dL (30 g/L); ⑧ blood creatinine ≤ 1.5 × ULN; ⑨ generally normal bleeding and coagulation time, with PT prolongation ≤ 4 s; ⑩ no serious cardiopulmonary diseases;
For subjects with hepatitis B-related primary hepatocellular carcinoma (HBV-HCC) or hepatitis C-related primary hepatocellular carcinoma (HCV-HCC), those who are with the following conditions are eligible to be enrolled:
Subjects with no obvious genetic diseases;
Subjects who have not received any live attenuated vaccines within 4 weeks prior to the first administration;
Subjects who are able to follow the clinical study protocol and follow-up procedures.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengpei Zhu, MD | Contact | 13720019126 | puchzcp@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100005 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |