Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Guangzhou Bio-gene Technology Co., Ltd | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGFR CAR-T | Experimental | Group: 3 dose levels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cells | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety 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. | 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. | In CAR-T cells infusion, up to 52 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of CAR T cells in patients. | Cmax of CAR T cells in patients is monitored by flow or qPCR. | In CAR-T cells infusion, up to 6 weeks. |
| Peak plasma time (Tmax) of CAR T cells in patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT. | In CAR-T cells infusion, up to 52 weeks. |
| Time to Response (TTR) | Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT. |
Inclusion Criteria:
Glucocorticoid: The therapeutic dose of glucocorticoid must be stopped 2 weeks before the EGFR CAR-T infusion. However, the following physiological replacement doses of glucocorticoids are allowed: 12 mg/m2 / dihydrogenated cortisone or equivalent; Immunosuppressive drugs: any immunosuppressive drugs must be stopped before they are selected for 4 weeks; Stop using granulocyte colony factor a week before plasmaphoresis.
Exclusion Criteria:
Adequate treatment of basal or squamous cell carcinoma(adequate wound healing prior to entry into the study);In situ cancer of the cervix or breast cancer with no signs of recurrence at least three years prior to the study following curable treatment; The primary malignant tumor has been completely removed and has been completely relieved for 5 years.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuxiang Ma, M.D. | Contact | 86 020 87343894 | mayx@sysucc.org.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Tmax of CAR T cells in patients is monitored by flow or qPCR.
| 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. | In CAR-T cells infusion, up to 6 weeks. |
| In CAR-T cells infusion, up to 52 weeks. |
| Progression-Free Survival (PFS) | Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT. Kaplan-Meier plots will be used to summarize the progression-free survival. | In CAR-T cell infusion, up to 52 weeks. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided