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 advanced bone and soft tissue tumors.
Age 16 to 75 years, diagnosed with soft tissue sarcoma or bone neoplasms clearly by histology and/or cytology.
Failure of standard treatment or patient unwillingness to receive other antitumor therapy.
No absolute or relative centasis contraindiction.
Subjects with ECoG score of 0-2.
Have had any serious adverse reactions associated with immunotherapy and have not recovered to CTCAE 5.0 grade rating 0 or 1 level of toxicity after previous antineoplastic therapy.
Subjects with any severe and/or uncontrolled disease, including: a) poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); b) suffering from class I or higher myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470 ms and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification); c) active or uncontrolled severe infection (≥ CTCAE grade 2 infection); d) Patients with previous organ transplantation, bone marrow transplantation (hematopoietic stem cell transplantation) and severe immune deficiency; e) Urine routine suggesting urine protein ≥++ and confirmed 24-hour urine protein quantification > 1.0 g.
Patients with past history of type I diabetes mellitus or HIV.
Severe abnormalities in thyroid and cortisol testing; active, known or suspected autoimmune disease requiring systemic therapy.
Single group
Recombinant oncolytic herpes simplex virus type Ⅰ (R130)
DrugR130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11
Subject incidence of adverse events
To characterize the safety profile of R130 injection in patients with relapsed/refractory bone and soft tissue tumors as measured by the incidence of Grade ≥ 3 Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0)
Subject incidence of laboratory abnormalities
Detection of liver and renal function, electrocardiogram, routine blood examination etc
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)
Disease Assessment for Disease Control Rate
Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST
Disease Assessment for Duration of Response
Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST
Quality of Life Assessment
Evaluate with EORTC QLQ-C30
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Shanghai Yunying Medical Technology
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
