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Trial Title:
A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Relapsed/Refractory Head and Neck Cancer
NCT ID:
NCT05830240
Condition:
Head and Neck Cancer
Esophageal Cancer
Otorhinolaryngologic Neoplasms
Ear Cancer
Nose Cancer
Laryngeal Cancer
Pharyngeal Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Laryngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Conditions: Keywords:
Oncolytic virus
Herpes simplex virus type 1
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Recombinant oncolytic herpes simplex virus type 1 (R130)
Description:
R130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3
scFv/CD86/PD1/HSV2-US11
Arm group label:
R130 Treatment Group
Other name:
Oncolytic virus
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Eye & ENT Hospital of Fudan University
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Recruiting
Contact:
Last name:
Haitao Wu, Ph.D
Phone:
+86 18917785578
Email:
eentwuhaitao@163.com
Contact backup:
Last name:
Jian Chen
Phone:
+86 18917785406
Email:
chenjent@qq.com
Start date:
March 27, 2023
Completion date:
March 27, 2026
Lead sponsor:
Agency:
Shanghai Yunying Medical Technology
Agency class:
Industry
Collaborator:
Agency:
Eye & ENT Hospital of Fudan University
Agency class:
Other
Source:
Shanghai Yunying Medical Technology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05830240
