9 participants are expected to be enrolled for this open,single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus Ⅰ, R130 in patients with relapsed/refractory head and neck cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
R130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11
Eye & ENT Hospital of Fudan University
Shanghai, China
RECRUITINGSafety Profile Measured by Grade ≥3 CTCAE v5.0
To characterize the safety profile of R130 injection in patients with relapsed/refractory head and neck cancer as measured by the incidence of Grade ≥ 3 Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0)
Time frame: Up to 6 months
Systemic immune response
Detection of increased systemic immune Response markers in sera (IL2,IL4,IL6,IL8,IL10,TNFa,IFNγ, etc.) and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS)
Time frame: Up to 6 months
Disease Assessment for Disease Control Rate
Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST
Time frame: Every 10 weeks for 12 months
Disease Assessment for Duration of Response
Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST
Time frame: Every 10 weeks for 12 months
Quality of Life Assessment
Evaluate with EORTC QLQ-C30
Time frame: Every 6 weeks for 12 months
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