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This is a open-label, single center, cohort study to determine the efficacy and safety of IM83 CAR-T cells in patients with advanced Liver Tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IM83 CAR-T cells | Experimental |
| |
| IM83 CAR-T cells +The second-line treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IM83 CAR-T cells | Biological | 3×10^9 CAR-T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) and abnormal laboratory test results as assessed by CTCAE V5.0 | Up to 28 days after CAR-T cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR, defined as the proportion of participants with a complete response or partial response, as determined by the investigator according to RECIST v1.1 | At 28 days, 3 months and 6 months after CAR-T cell infusion |
| Duration of Response (DOR) |
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Inclusion Criteria:
ANC≥ 1.5 × 10 ^ 9 / L,platelet ≥ 75 × 10 ^ 9 / L ,Hemoglobin ≥ 90 g / L,Serum creatinine ≤ 1.5 ULN,serum bilirubin ≤ 3 ULN,INR≤ 2,AST and ALT)≤ 5.0 ULN,Creatinine clearance rate ≥ 60 ml / min.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Wu, MD | Contact | +8615801390058 | wufei@immunochina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA GENERAL HOSPITAL | Recruiting | Beijing | Beijing Municipality | 100039 | China |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| The second-line treatment of liver cancer | Combination Product | approved by NMPA |
|
DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) in Stage 1, as determined by the investigator according to RECIST v1.1 |
| Up to 24 weeks after CAR-T cell infusion |
| Progression-free survival (PFS) | PFS, defined as the time from CAR-T cell infusion to the first occurrence of disease progression or death from any cause (whichever occurs first) , as determined by the investigator according to RECIST v1.1 | Up to 24 weeks after CAR-T cell infusion |
| Overall survival (OS) | OS , defined as the time from CAR-T cell infusion to death from any cause | Up to 24 weeks after CAR-T cell infusion |
| Plasma levels of α fetoprotein (AFP) cells infusion | At 28 days, 3 months and 6 months after CAR-T cell infusion |
| Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood) | The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR. | Up to 24 weeks after CAR-T cell infusion |
| D008107 |
| Liver Diseases |