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

NCT05851456 | Recruiting Early Phase 1

• 1 other identifier: XAHH-R130-BSTT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteosarcoma; Sarcoma; Sarcoma,Soft Tissue; Bone Tumor

Keywords

Oncolytic virus; Herpes simplex virus type 1; Immunotherapy

Outcome Measures

Primary Outcomes (3)

• 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)

  Up to 6 months

• Subject incidence of laboratory abnormalities

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

  Up to 1 month

• 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)

  Up to 6 months

Secondary Outcomes (3)

• Disease Assessment for Disease Control Rate

  Every 10 weeks for 12 months

• Disease Assessment for Duration of Response

  Every 10 weeks for 12 months

• Quality of Life Assessment

  Every 6 weeks for 12 months

Study Arms (1)

R130 Treatment Group

EXPERIMENTAL

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.

Drug: Recombinant oncolytic herpes simplex virus type Ⅰ (R130)

Interventions

Recombinant oncolytic herpes simplex virus type Ⅰ (R130) DRUG

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

Also known as: Oncolytic virus Injection

R130 Treatment Group

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 14 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.
• Expected survival of 3 months or more.
• Have at least one measurable lesion (according to RECIST 1.1 criteria) that is amenable to intratumoral drug delivery.
• Subjects must have appropriate organ function, and laboratory tests during the screening period must meet the following requirements: a) absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets (PLT) ≥ 80 × 109/L, and hemoglobin (Hb) ≥ 85 g/L; b) serum creatinine (Cr) and blood urea nitrogen (BUN) within 1.5 times the upper limit of normal values; c) serum total bilirubin (TBIL) ≤ 2 times the upper limit of normal values; d) glutamic aminotransferase (ALT) and glutamic oxalacetic aminotransferase (AST) ≤ 2.5 times the upper limit of normal values; subjects with liver metastases do not exceed 5 times the upper limit of normal values; e) activated partial thromboplastin time (APTT), prothrombin time (PT) within 1.5 times the upper limit of normal values.
• Any treatment for malignancy, including radiotherapy, chemotherapy and biological agents, must be discontinued 28 days prior to R130 treatment.
• Eligible patients of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) with their partner for the duration of the trial and for at least 180 days after the last dose; female patients of childbearing potential must have a negative urine pregnancy test within 7 days prior to enrollment.
• Subjects voluntarily sign an informed consent form and are in good compliance.

You may not qualify if:

• 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.
• Patients with active tuberculosis and a strong positive OT test.
• Patients with active bleeding or severe coagulation dysfunction.
• Have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targeted therapy, immunotherapy and antitumor herbal therapy, 4 weeks prior to the first dose.
• Current active hepatitis B, active hepatitis C, immunodeficiency virus or other active infection of clinical significance.
• Patients who have undergone surgery of grade 3 or higher or whose surgical wounds have not healed within 4 weeks prior to enrollment.
• Pregnant, lactating and planning to have children within six months.
• Subjects who, in the judgment of the investigator, are unsuitable for participation in this trial for any reason.

Sponsors & Collaborators

• Shanghai Yunying Medical Technology: lead
• Xi'an Honghui Hospital: collaborator

Study Sites (1)

Xi'an Honghui Hospital

Xi'an, Shaanxi, 710000, China

RECRUITING

MeSH Terms

Conditions

Osteosarcoma; Sarcoma; Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Feng Pan, MD

CONTACT

+8613764868528; pf@jxyymedtech.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 9, 2023
• Study Start: April 10, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: May 9, 2023

Record last verified: 2023-04

Locations

CN (1)