This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U87 injection solution in patients with advanced malignant head and neck tumors.
Following consent, patients must have tumor tissue evaluated by IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (U87). Following manufacture of the drug product, subjects will receive preconditioning prior to U87 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Treatment with U87 chimeric antigen receptor T-cell infusion.
Eye ENT Hospital of Fudan University
Shanghai, China
RECRUITINGIncidence of Adverse events after U87 CAR-T cells infusion [Safety and Tolerability]
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Time frame: 28 days post administration of CAR-T-cells
Pharmacokinetics of U87 CAR-T cells
Time at the maximal concentration(Tmax)
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cells
Area under the concentration-time curve(AUC)
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cells
The maximal concentration of eripheral blood (Cmax)
Time frame: 2 years post CAR T cell infusion
Pharmacodynamics of U87 CAR-T cells
Concentration levels of CAR-T-related serum cytokines such as IL-6, IFN γ, ferritin and CRP at each time point
Time frame: 2 years post CAR T cell infusion
Objective Response Rate (ORR), as assessed by Investigators
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
Time frame: 2 years post CAR T cell infusion
Duration of response (DOR), as assessed by Investigators
Duration of response (DOR) is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.
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Time frame: 2 years post CAR T cell infusion
Overall survival (OS)
Overall Survival (OS) was defined as the time from the date of first infusion of U87 to the date of death due to any cause.
Time frame: 2 years post CAR T cell infusion
Progression-free survival (PFS), as assessed by Investigators
Progression-free survival (PFS) was defined as the time from the date of randomization to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.
Time frame: 2 years post CAR T cell infusion
Disease control rate (DCR), as assessed by Investigators
Disease control rate (DCR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.
Time frame: 2 years post CAR T cell infusion