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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
CAR-NKT Cells treatment
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.
Time frame: Day 28 after CGC738 infusion
ORR
Assess Objective response rate
Time frame: Day 1 through week 56
DCR
Assess Disease control rate
Time frame: Day 1 through week 56
AEs
Incidence of adverse events
Time frame: Day 1 through week 56
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