This study is a clinical study on the safety, efficacy and I phase of single center, single arm, open-dose climbing, intravenous infusion of Anti- Epidermal growth factor receptor(EGFR) Chimeric Antigen Receptor(CAR) T cells modified by C-X-C Chemokine receptor type 5(CXCR 5) in patients with advanced adult non-small cell lung cancer(NSCLC).
In this study, the dose(number of cells by body weight) and time of infusion should be recorded in detail according to the dosage of slope climbing and single infusion. The safety of chimeric antigen receptor T(CAR-T) cells treatment was evaluated by observing the adverse events after cell therapy. The effectiveness of CAR-T treatment was initially assessed compared with the results of the patient's own previous standard treatment plan. Blood was collected before and within 12 months after infusion to detect the number and activity of CAR-T cells and evaluate the pharmacokinetic characteristics of CAR-T cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
The first dose group: 0.5 × 10\^6/kg CAR positive T cells; The second dose group: 1.58 × 10\^6 / kg CAR positive T cells; The third dose group: 5 × 10\^6/kg CAR positive T cells. The above dose allows a 20 % error; For subjects with body weight greater than 60 kg, the number of cells can only be calculated according to 60 kg of body weight.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGSafety by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
The type, frequency, severity, and duration of adverse events as a result of EGFR CAR T cells infusion will be summarized.
Time frame: In CAR-T cells infusion, up to 52 weeks.
Objective Response Rate (ORR)
Per Response Evaluation Criteria in Solid Tumours (RECIST 1.1) assessed by MRI or CT. ORR is the percentage of patients at Complete Response (CR) or Partial Response (PR) (according to independent review), prior to progression or further anti-cancer therapy.
Time frame: In CAR-T cells infusion, up to 52 weeks.
Peak Plasma Concentration (Cmax) of CAR T cells in patients.
Cmax of CAR T cells in patients is monitored by flow or qPCR.
Time frame: In CAR-T cells infusion, up to 6 weeks.
Peak plasma time (Tmax) of CAR T cells in patients.
Tmax of CAR T cells in patients is monitored by flow or qPCR.
Time frame: In CAR-T cells infusion, up to 6 weeks.
Area under the plasma concentration versus time curve (AUC) of CAR T cells in patients.
AUC of CAR T cells in patients is monitored by flow or qPCR.
Time frame: In CAR-T cells infusion, up to 6 weeks.
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