Infections

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Rare Diseases

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Soft Tissue Neoplasms

Bone Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

All Drugs and Chemicals

Immunomodulating Agents

Muromonab-CD3

Every 7-14 days,1-2 ml R130 （concentration of 1x10\^8 plaque-forming Units/mL,PFU/mL）will be injected intratumoral in patients with relapsed/refractory bone and soft tissue tumors.

R130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11

Recombinant oncolytic herpes simplex virus type Ⅰ (R130)

Pan Feng, MD

Yingqi Hua, MD

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.

A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Advanced Bone and Soft Tissue Tumors

A Clinical Safety and Efficacy Study on Oncolytic Virus Injection (R130) for the Treatment of Advanced Bone and Soft Tissue Tumors

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)

Detection of liver and renal function, electrocardiogram, routine blood examination etc

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)

Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST

Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai Yunying Medical Technology

Every 7-14 days,1-6 ml R130 （concentration of 1x10\^8 plaque-forming Units/mL,PFU/mL）will be injected intratumoral in patients with relapsed/refractory bone and soft tissue tumors.

Feng Pan, MD

Zhichao Tong, Ph.D

20 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 bone and soft tissue tumors.

A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Bone and Soft Tissue Tumors

A Clinical Safety and Efficacy Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Bone and Soft Tissue Tumors

Detection of liver and renal function, electrocardiogram, routine blood examination etc.

Xi'an Honghui Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Every 7-14 days,1-4 ml R130 （concentration of 1x10\^8 plaque-forming Units/mL,PFU/mL）will be injected intratumoral or Intraperitioneal in patients with relapsed/refractory cervical and endometrial Cancer.

Feng Pan

Jing Guo, Phd

Zhongping Cheng, MD

20 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 Cervical and Endometrial Cancer.

A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Cervical and Endometrial Cancer

A Clinical Safety and Efficacy Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Cervical and Endometrial Cancer

All serious and non-serious adverse events that occur after enrollment through 7 (+14) days after the last administration of R130 will be recorded

Detection of increased systemic immune Response markers in sera,ascites and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Advanced Bone and Soft Tissue Tumors	NCT06171282	Osteosarcoma Sarcoma Soft Tissue Sar... Bone Tumor	Recombinant onc...	16 Years - 75 Years	Shanghai Yunying Medical Technology
A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Bone and Soft Tissue Tumors	NCT05851456	Osteosarcoma Sarcoma Sarcoma,Soft Ti... Bone Tumor	Recombinant onc...	14 Years - 75 Years	Shanghai Yunying Medical Technology
A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Cervical and Endometrial Cancer	NCT05812677	Cervical Cancer Endometrial Can... Advanced Cancer	Recombinant onc...	18 Years - 75 Years	Shanghai Yunying Medical Technology

Spots Global Cancer Trial Database for recombinant oncolytic herpes simplex virus type ⅰ (r130)