Not provided
Not provided
Not provided
Not provided
Not provided
Due to corporate strategic adjustment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a single-arm, single-center investigator-initiated trial (IIT) designed to evaluate the safety and preliminary efficacy of CDH17/GUCY2C CAR-T cell therapy in patients with advanced colorectal cancer, as well as to assess its pharmacodynamic (PD) and pharmacokinetic (PK) profiles.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T | Experimental | The dosage range of 1.0 × 10^6/kg (± 20%) to 5.0 × 10^6/kg (± 20%) of CAR-T cells, administered either intravenously or intratumorally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR-T | Biological | Eligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Safety | Count the Incidence of adverse events | Up to 1 year after CAR-T infusion |
| Effectiveness evaluation | In accordance with the RECIST 1.1 criteria for assessing the efficacy of solid tumors, the objective response rate (ORR), encompassing patients achieving complete response (CR) and partial response (PR). | Up to 1 years after CAR-T infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters | The highest concentration of CAR-T cell expansion in peripheral blood after administration | Up to 1 year after CDH17/GUCY2C CAR-T infusion |
| Pharmacodynamic parameters |
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 |
|---|---|---|---|---|---|---|
| Dongguan Taixin Hospital | Dongguan | Guangdong | 523125 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The peak values of CAR-T-related cytokines, which include at least IL-6 and IFN-γ.
| Up to 1 year after CAR-T infusion |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |