This is a single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of UCL70805F in patients with CD70-positive advanced renal clear cell carcinoma.
This study will include two parts, dose escalation phase (modified "3+3" design) followed by a dose expansion phase. All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide, followed by a single intravenous infusion of UCL70805F. The recommended phase 2 dose (RP2D) will be determined during the dose escalation phase. In the dose expansion phase, one or two dose levels may be selected to further characterize the safety profile and evaluate the efficacy of UCL70805F.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
D0: 5×10\^4 cells ~ 4×10\^5 cells
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Adverse Events (AEs)
Incidence and severity of adverse events.
Time frame: 2 years
Serious Adverse Events (SAEs)
Incidence and severity of serious adverse events.
Time frame: 2 years
Dose-limiting Toxicities (DLTs)
Incidence and severity of dose-limiting toxicities (DLTs) following infusion of UCL70805F, at each dose level tested in dose escalation phase.
Time frame: 4 weeks
Objective Response Rate (ORR)
The Objective Response Rate (ORR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
Time frame: 2 years
Disease Control Rate (DCR)
Disease control rate (DCR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.
Time frame: 2 years
Progression-Free Survival (PFS)
PFS is defined as the time from UCL70805F infusion to the date of the disease progression or death from any cause.
Time frame: 2 years
Overall Survival (OS)
OS is defined as the time from UCL70805F infusion to the date of death due to any cause.
Time frame: 2 years
CAR copies in Peripheral Blood
CAR copies will be measured by qPCR to evaluate the expansion and persistence of UCL70805F in vivo.
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Time frame: 2 years
Cytokine Level in Peripheral Blood
Level of cytokines in serum.
Time frame: 2 years