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This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC738 in the treatment of advanced clear cell renal cell carcinoma (ccRCC).
This is a single-arm, open-label study. This study will include two parts, dose escalation phase (3+3 design) followed by a dose expansion phase. All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by CAR-T cell injection.
Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of anti-CD70 CAR-T cell injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-NKT Cells Lymphodepleting regimen | Experimental | CAR-NKT Cells treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGC738 | Drug | CAR-NKT Cells treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) | Dose limiting toxicity (DLT) is an AE that meets the following criteria and occurs within 28 days of CGC738 infusion.AE is graded according to CTCAE version 5.0. | Day 28 after CGC738 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Assess Objective response rate | Day 1 through week 56 |
| DCR | Assess Disease control rate | Day 1 through week 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhai Wei | Contact | +8618701771959 | jackyzw2007@163.com |
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| AEs | Incidence of adverse events | Day 1 through week 56 |