Head and neck squamous cell carcinoma
Conditions
Interventions
Low-dose group:CD70 CAR-T 3×10^7 Intratumor Injection
High-dose group:CD70 CAR-T 3×10^8 Intratumor Injection
Sponsors
The Ninth People's Hospital Affiliated to Medical College of Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following inclusion criteria must be met to be enrolled: 1. Patients with head and neck squamous cell carcinoma who fail to receive standard treatment have no disease progression or other effective treatment options. 2. Patients with head and neck squamous cell carcinoma with CD70 +: CD70 + is defined as tumor tissue immunohistochemical staining >= 2 +, that is, in 10% of tumor cells, the staining intensity is greater than weak to moderate. 3. Systemic assessment of patients with head and neck squamous cell carcinoma was normal within one week before treatment: (1) Hematological examination: neutrophil count (ANC) >= 1.0 x 10^9 / L; hemoglobin >= 9g / dl; platelet count >= 100 x 10^9 / L; Pt or APTT = 60 ml / min. (4) Cardiac function: LVEF >= 52%. 4. The patient or his legal representative agreed to participate in the clinical study and signed the informed consent.
Exclusion criteria
Exclusion criteria: Those who met any of the exclusion criteria were excluded from the study 1. Patients who use glucocorticoid continuously and can't stop taking glucocorticoid; 2. Patients with active autoimmune diseases or immunosuppressed patients (such as immunodeficiency, organ transplantation, etc.); 3. Patients with active infectious diseases, such as hepatitis B, syphilis, etc; 4. Patients with severe systemic diseases such as heart, liver and kidney dysfunction; 5. Patients during pregnancy or lactation; 6. Patients with severe mental illness or poor compliance who cannot complete the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Response evaluation of solid tumor;Quality of Life; | — |
Countries
China
Contacts
Public ContactYue He
The Ninth People's Hospital Affiliated to Medical College of Shanghai Jiaotong University
Outcome results
None listed