This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC729 in the treatment of advanced malignant solid tumors. Condition or disease:advanced malignant solid tumors. Intervention/treatment:Biological: CD70 CAR-NKT cells. Phase:I
This was a dose-expansion study, we plan to enroll 6 to 12 patients with CD70-positive advanced malignant solid tumors to CGC729 treatment. The intended enrollment for the evaluation of treatment efficacy and safety was planned to be 3 to 6 patients per tumor type. We used leukapheresis for cell collection. The lymphodepletion procedure was conducted using a combination of fludarabine and cyclophosphamide.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Biological: CD70 CAR-NKT cells. Drug: Cyclophosphamide. Drug: Fludarabine.
Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGORR of CD70 CAR-NKT cell dynamics
Assess Objective response rate
Time frame: Day 1 through week 56
DCR of CD70 CAR-NKT cell dynamics
Disease control rate
Time frame: Day 1 through week 56
DOR of CD70 CAR-NKT cell dynamics
Duration of Response
Time frame: Day 1 through week 56
PFS of CD70 CAR-NKT cell dynamics
Progress Free Survival
Time frame: Day 1 through week 56
OS of CD70 CAR-NKT cell dynamics
Overall survival
Time frame: Day 1 through week 56
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