Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Phase 1 Study of IL1RAP-targeting Chimeric Antigen Receptor T cells in the Treatment of Relapsed/Refractory Hepatocellular Carcinoma
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :1.0×10^8(First dose group) | Biological | Different dose groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Dose Limited Toxicity | Within 28 days after the cell infusion | |
| Number of participants with treatment associated adverse events (AE) and serious adverse events (SAE) according to CTCAE v5.0 | From the start of PBMC collection until subject withdrawal or 12 months after cell infusion, participants who withdraw without cell infusion will be only collected for AEs within 28 days after the study-related procedure or other treatment begins | |
| Number of participants with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) | From the start of PBMC collection until subject withdrawal or 12 months after cell infusion, participants who withdraw without cell infusion will be only collected for AEs within 28 days after the study-related procedure or other treatment begins | |
| Number of participants with treatment associated changes in clinically significant laboratory safety test values | From the start of PBMC collection until subject withdrawal or 12 months after cell infusion, participants who withdraw without cell infusion will be only collected for AEs within 28 days after the study-related procedure or other treatment begins |
| Measure | Description | Time Frame |
|---|---|---|
| Curative effect evaluation | 3-month objective response rate (ORR); 、 | 3 months after cell infusion |
| Disease control rate (DCR) | 3 months, 6 months, 1 year, 2years after cell infusion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :2.5×10^8(Second dose group) | Biological | Different dose groups |
|
| Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :5.0×10^8(Third dose group) | Biological | Different dose groups |
|
| Changes of serum IL1RAP level | 3 months, 6 months, 1 year, 2years after cell infusion |
| Changes of copy number and absolute value of CAR-T cells targeting IL1RAP in peripheral blood | 3 months, 6 months, 1 year, 2years after cell infusion |
| Progression-free survival (PFS) | 3 months, 6 months, 1 year, 2years after cell infusion |
| Median PFS | 3 months, 6 months, 1 year, 2years after cell infusion |
| Time to remission (TTR) | 3 months, 6 months, 1 year, 2years after cell infusion |
| Duration of response after administration (DOR) | 3 months, 6 months, 1 year, 2years after cell infusion |
| Survival time: Median overall survival (mOS) | 6 months, 1 year, 2years after cell infusion |
| OS rate | 6 months, 1 year, 2years after cell infusion |
| PFS rate | 3 months, 6 months, 1 year, 2years after cell infusion |