Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Infections

Rare Diseases

Death

Mesothelioma

Mesothelioma, Malignant

Adenoviridae Infections

Communicable Diseases

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Virus Diseases

DNA Virus Infections

Malignant Mesothelioma

This study observed 2-4 treatment cycles. For the convenience of statistics, this project stipulated that the first combined medication (v1) after the patient was enrolled in this study was administered with oncolytic virus (recombinant human adenovirus type 5) by intratumoral injection or intrapleural injection on the 1-3 days. On the 4th or 5th day, PD-1 injection was administered once per cycle. The completion of two visits in this study is considered a completed case, and subsequent treatment is determined jointly by the researcher and the subject.

The oncolytic virus(H101) is administered by intratumoral injection or intrapleural injection on days 1-3 of the first medication cycle. PD-1 inhibitor is administered on days 4 or 5, with one infusion per cycle. The treatment regimen consists of 2-4 cycles

Oncolytic Adenovirus H101

Programmed death receptor-1 inhibitor

Haitao Wang, Ph.D

Jinhuan Wang, Ph.D

Lili Wang, MM

Haitao Wang

Lili Wang

Jinhuan Wang

Dingkun Hou

Lei Wang

The purpose of this study is to evaluate the efficacy and safety of Oncolytic Adenovirus(H101) combined with PD-1 inhibitor in patients with advanced malignant pleural mesothelioma who have previously been resistant to advanced PD-1 inhibitors.

By monitoring the clinical symptoms of patients with advanced immune resistant pleural mesothelioma treated with adenovirus injection combined with programmed death receptor (PD-1) inhibitors, we analyze and explore the effectiveness and safety of using oncolytic virus drugs. Exploring the influencing factors of using oncolytic adenovirus injection combined with PD-1 inhibitors to reverse immune resistance in MPM patients. Evaluate the safety of the drug, and finally evaluate the quality of life of patients using oncolytic adenovirus injection(H101) combined with PD-1 inhibitors.

Oncolytic Adenovirus(H101) Combined With PD-1 Inhibitors in Patients With Advanced Malignant Pleural Mesothelioma

Observation of the Efficacy and Safety of Oncolytic Adenovirus Injection Combined With Programmed Death Receptor Inhibitors in Treatment of Advanced Malignant Pleural Mesothelioma : a Single Center, Prospective, Case Registration Study

The proportion of CR(complete response) and PR(partial response) in all patients.

The proportion of CR(complete response), PR(partial response) and SD(stable disease) in all patients.

Refers to the time from the first treatment day to the first occurrence of disease progression or death from any cause (whichever occurs first), and the end point event is determined by the investigator according to RECIST version1.1.

Time between the date of grouping and death from any cause or the end of the last follow-up visit.

Toxicity were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. All serious and non-serious adverse events that occur after enrollment through 30 (+7) days after the last administration of H101 will be recorded.

Tianjin Medical University Second Hospital

Neoplasm Metastasis

Neoplastic Processes

Patients will received weekly (n=6) IV infusion of Celyvir.

CELYVIR

Manuel Ramírez, MD PhD

The investigators will evaluate the safety of weekly infusions (n=6) of CELYVIR in children and adults with metastatic and refractory solid tumors. CELYVIR consists in bone marrow-derived autologous mesenchymal stem cells (MSCs) infected with ICOVIR5, an oncolytic adenovirus. In addition to data on toxicities the investigators will evaluate clinical response.

Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.

Phase 1 Trial of Celyvir in Children and Adults With Metastatic and Refractory Solid Tumors.

We will record any sign or symptom that could be related to the infusion of Celyvir.

Clinical outcome will be labelled as complete response, partial response, stable disease or disease progression.

Instituto de Salud Carlos III

Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Carcinoma

Breast Neoplasms

Melanoma

Head and Neck Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Ovarian Cancer

Ovarian Epithelial Cancer

Pharmaceutical Solutions

All Drugs and Chemicals

1.Only 1 lesion: If the tumor volume is less than or equal to 10 cm3, the whole tumor is injected radially and evenly.

If the tumor volume was \>10 cm3, the tumor was evenly divided into five quadrants and injected into one quadrant at a time.

2. If there are 2 or more lesions, the most manageable tumor injection is selected; 3. Priority should be given to the body surface metastases that meet the evaluation criteria for tumor efficacy.

4. According to patients' conditions (e.g., patients with thorax and ascites), the investigator and the research group and cooperative units jointly explored other drug administration approaches (e.g., bladder infusion, thorax and abdominal cavity administration)

Before use, dilute the product with normal saline according to the size of the tumor to an appropriate volume (10-30% of the total volume of the tumor), or adjust appropriately according to the specific tumor situation, inject directly into the tumor or inject under the guidance of B ultrasound /CT, inject the drug solution into the tumor edge and tumor evenly

Recombinant L-IFN adenovirus injection

Rong Zhang, MD

Feng Liu, PhD

This is an open-label, dose escalation study of the safety and tolerability of Recombinant oncolytic adenovirus L-IFN injection（YSCH-01） when administered via intratumoral injection in patients with advanced solid tumors. The purpose of this study is to assess the safety and tolerability of Recombinant L-IFN adenovirus injectionand to determine the recommended phase 1 dose for further study. The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of Recombinant L-IFN adenovirus injection

This is an investigator initiated , open-label, study of Recombinant oncolytic adenovirus L-IFN injection given via intratumoral (IT) injection as a single agent in participants with advanced solid tumors. The study is a single agent dose escalation which will use a 3+3 design to evaluate escalating doses of Recombinant L-IFN adenovirus injection. Total enrollment will depend on the toxicities and/or activity observed, with approximately19-28 evaluable participants enrolled.

The primary study objective is to determine the safety, tolerability, and maximum tolerated dose (MTD) of intratumoral administration of Recombinant oncolytic adenovirus L-IFN injection as a single agent. Secondary objectives will assess efficacy overall response rate, as well as disease control rate, progression free survival, duration of response, and anti-tumor immune responses.

Safety and Efficacy of Recombinant Oncolytic Adenovirus L-IFN Injection in Relapsed/Refractory Solid Tumors Clinical Study

Safety and Efficacy of Recombinant L-IFN Adenovirus Injection in Relapsed/Refractory Solid Tumors: a Single/Multicenter, Dose-increasing, Cohort Extension Clinical Study

To define the maximum tolerated dose (MTD) of intratumoral administration of Recombinant L-IFN adenovirus injection in humans with malignant tumors.

An AE is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP

Number of participants with potentially clinically significant laboratory values

To evaluate the immunogenicity of Recombinant L-IFN adenovirus injection given as single agent post injection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oncolytic Adenovirus(H101) Combined With PD-1 Inhibitors in Patients With Advanced Malignant Pleural Mesothelioma	NCT06031636	Malignant Pleur...	Oncolytic Adeno... Programmed deat...	18 Years - 75 Years	Tianjin Medical University Second Hospital
Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.	NCT01844661	Children Solid Tumors Metastases	CELYVIR	6 Months - 75 Years	Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.	NCT01844661	Children Solid Tumors Metastases	CELYVIR	6 Months - 75 Years	Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Oncolytic Adenovirus(H101) Combined With PD-1 Inhibitors in Patients With Advanced Malignant Pleural Mesothelioma	NCT06031636	Malignant Pleur...	Oncolytic Adeno... Programmed deat...	18 Years - 75 Years	Tianjin Medical University Second Hospital
Safety and Efficacy of Recombinant Oncolytic Adenovirus L-IFN Injection in Relapsed/Refractory Solid Tumors Clinical Study	NCT05180851	Head and Neck C... Melanoma Breast Cancer Bladder Cancer Ovarian Carcino... Cervical Carcin... Lung Cancer	Recombinant L-I...	18 Years - 75 Years	Shanghai Fengxian District Central Hospital

Spots Global Cancer Trial Database for oncolytic adenovirus