A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Relapsed/Refractory Head and Neck Cancer

NCT ID: NCT05830240

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2026-03-27

Brief Summary

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.

Conditions

Head and Neck Cancer; Esophageal Cancer; Otorhinolaryngologic Neoplasms; Ear Cancer; Nose Cancer; Laryngeal Cancer; Pharyngeal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R130 Treatment Group

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 head and neck cancer

Group Type: EXPERIMENTAL

Recombinant oncolytic herpes simplex virus type 1 (R130)

Intervention Type: DRUG

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

Interventions

Recombinant oncolytic herpes simplex virus type 1 (R130)

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

Intervention Type: DRUG

Other Intervention Names

Oncolytic virus

Eligibility Criteria

Inclusion Criteria

1. Patients with head and neck cancer clearly diagnosed by histology and/or cytology, without systematic metastasis, and failure of standard treatment.

2. Age 18 to 75 years.

3. No absolute or relative centasis contraindiction，have at least one measurable lesion (according to RECIST 1.1 criteria) that is amenable to intratumoral drug delivery.

4. No severe functinonal falure of heart, brain, liver, kidney and lung.

5. Subjects with ECOG score of 0-2, and expected survival of 3 months or more.

6. No evidence of clinically significant immunosuppression.

7. Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function during the screening period:

• White Blood Cell (WBC)≥3.0×10^9/L；
• Absolute Lymphocyte Count (ANC)≥1.5×10^9/L;
• Platelet≥100×10^9/L；
• Prothrombin time (PT) or activated Partial Thromboplastin Time（APTT）≤1.5×ULN;
• Serum Creatinine (Scr)≤1.5×ULN
• Alanine aminotransferase(AST/ALT) ≤3×ULN;
• Total Bilirubin(TBIL)≤1.5×ULN.

8. Be able to understand and sign the informed consent document;

9. Be able to stick to follow-up visit plan and other requirements in the agreement.

Exclusion Criteria

1. With a history of allergy to similar drugs.

2. With hematological diseases, malignant tumors of the central nervous system, or combined with other malignant tumors.

3. pregnancy, breast feeding.

4. Current active hepatitis B, active hepatitis C, immunodeficiency virus or other active infection of clinical significance.

5. Impaired function of important organs or a history of organ transplantation.

6. Receiving antiherpes simplex virus therapy such as acyclovir, ganciclovir, vancomycin, and acepromazine within 4 weeks.

7. Have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targeted therapy, immunotherapy and antitumor herbal therapy,4 weeks prior to the first dose.

8. 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.

9. 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.

10. Patients with past history of type I diabetes mellitus.

11. Severe abnormalities in thyroid and cortisol testing; active, known or suspected autoimmune disease requiring systemic therapy.

12. Patients with active bleeding or severe coagulation dysfunction.

13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: collaborator

Shanghai Yunying Medical Technology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haitao Wu, Phd

Role: PRINCIPAL_INVESTIGATOR

Eye & ENT Hospital of Fudan University

Locations

Eye & ENT Hospital of Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Feng Pan, MD

Role: CONTACT

pf@jxyymedtech.com

+86 13764868528

Facility Contacts

Haitao Wu, Ph.D

Role: primary

eentwuhaitao@163.com

+86 18917785578

Jian Chen

Role: backup

chenjent@qq.com

+86 18917785406

Other Identifiers

SHWG-R130-HNC

Identifier Type: -

Identifier Source: org_study_id