This is a phase I, open-label, single-arm study conducted to evaluate the safety, tolerability, PK, and preliminary efficacy of CGC729 with Relapsed or Metastatic advanced renal cell carcinoma. Condition or disease:Renal Cell Carcinoma Intervention/treatment: Biological: CD70 CAR-NKT cells Phase 1
Dose exploration for this study will be a 3+3 design with a target DLT rate of \<1/3. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. Dose exploration can be discontinued once one or more dose levels with an acceptable safety profile and satisfactory antitumor activity have been selected for subsequent evaluation. During the treatment period of the study, three dose levels of CGC729 will be evaluated. Each of the dose levels will evaluate the safety of the CAR-NKT cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Biological: CD70 CAR-NKT cells. Drug: Cyclophosphamide. Drug: Fludarabine.
Jian Zhang
Shanghai, China
RECRUITINGPercentage of Participants Experiencing DLT
1.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 CGC729 infusion.AE is graded according to CTCAE version 5.0.
Time frame: Day 28 after CGC729 infusion
ORR of CD70 CAR-NKT cell dynamics.
Assess Objective response rate(ORR)
Time frame: Day 1 through week 52
DCR of CD70 CAR-NKT cell dynamics.
Disease control rate (DCR)
Time frame: Day 1 through week 52
The safey of CD70 CAR-NKT cell dynamics
Adverse events (AEs) of CD70 CAR-NKT cell dynamics, Duration and severity of AEs,AE is graded according to CTCAE version 5.0.
Time frame: Day 1 through week 52
Cmax of CD70 CAR-NKT cell dynamics.
Peak Plasma Concentration
Time frame: Day 1 through week 52
Tmax of CD70 CAR-NKT cell dynamics.
Time to Maximum Plasma Concentration
Time frame: Day 1 through week 52
AUC of CD70 CAR-NKT cell dynamics.
Area under the plasma concentration versus time curve
Time frame: Day 1 through week 52
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