This is a Phase l, Open-Label, Dose-escalation Study to Evaluate the Safety, Tolerabilityand Antitumor Activity of TH027 CAR-T Cell lnjection (TH-CART-027) in Subjects With Relapsed or Refractory Solid Tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
3+3 dose escalation design: Dose Level 1: 0.3×10\^6 CAR+ T cells /kg; Dose Level 2: 1.0×10\^6 CAR+ T cells /kg; Dose Level 3: 3.0×10\^6 CAR+ T cells /kg
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, China
Safety:Incidence of Dose Limiting Toxicity (DLT)
Limiting toxicity type, incidence, and severity of dose limiting toxicities (DLTs) within 28 days after the first TH-CART-027 infusion
Time frame: 28 days after the first TH-CART-027 infusion.
Safety:Incidence and severity of adverse events (AEs)
To evaluate possible adverse events after TH-CAPT-027 infusion, including the incidence and severity of AEs.
Time frame: Six months post CAR-T cells infusion.
Overall survival (OS)
Time from treatment initiation to death from any cause.
Time frame: 12 and 24 months post CAR-T cells infusion.
Objective response rate (ORR)
The assessment will be based on the investigator's evaluation of imaging evaluations, with efficacy evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). ORR refers to the proportion of patients with objective evidence of achieving a Complete Response (CR) or Partial Response (PR). Where applicable, responses recorded after disease progression or initiation of non-investigational anticancer therapy will be excluded.
Time frame: 3 months post CAR-T cells infusion.
Progression Free Survival (PFS)
Defined as the time from initiation of the investigational drug to the first occurrence of progressive disease (PD) or death from any cause in the absence of documented PD. If no tumor progression is observed and the subject does not die during the study period, the analysis cutoff date will be determined as the date of the last tumor assessment.
Time frame: 1 year post CAR-T cells infusion.
Disease Control Rate (DCR)
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Defined as the proportion of patients achieving Partial Response (PR), Complete Response (CR), or Stable Disease (SD) according to RECIST 1.1 criteria, relative to the total number of cases in the study.
Time frame: 1 year post CAR-T cells infusion