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Due to corporate strategic adjustment.
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This single-arm, single-center investigator-initiated trial (IIT) evaluates the safety, efficacy, and pharmacodynamic (PD)/pharmacokinetic (PK) profiles of CAR-T cells in patients with advanced solid tumors.
Eligible subjects are followed until 12 months after infusion or until meeting treatment withdrawal criteria, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T | Experimental | The administration can be performed via intravenous infusion, either as a single dose or multiple doses, at a dosage ranging from 3×10⁶ to 1×10⁷ CAR-positive T cells per kilogram of body weight, with an allowable deviation of ±20%. |
|
| 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 years after CAR-T infusion |
| Effectiveness evaluation | According to the RECIST 1.1 evaluation criteria for the efficacy of solid tumors, the objective response rate (ORR) of all patients after CAR-T treatment, including complete response (CR) and partial response (PR). | Up to 1 year 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 CAR-T infusion |
| Pharmacodynamic parameters | The peak values of CAR-T-related cytokines, which include at least IL-6 and IFN-γ. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguan Taixin Hospital | Dongguan | Guangdong | 523125 | China |
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| Up to 1 year after CAR-T infusion |