Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Infections

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Virus Diseases

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

RT-01 will be administered intravenously on day 1 and 6, and every 8 weeks thereafter (up to 6 times)

Oncolytic Virus Injection(RT-01)

zhou huan, MD

This is a single-arm, open-label, clinical pharmacology study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in patients with Relapsed or Refractory T-cell Lymphoma. The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01.

This is an investigator initiated , single-arm, open-label clinical pharmacology study of RT-01 given via Intravenous injection in patients with advanced solid tumors. RT-01 will be administered on days 1 and 6, and every 8 weeks thereafter (up to 6 times).

This study is planned to enroll 6 patients with Relapsed or Refractory T-cell Lymphoma.

The purpose of this study is to assess the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01.

Intravenous Injection of Oncolytic Virus Injection (RT-01) in Patients With Relapsed or Refractory T-cell Lymphoma

A Sing-Arm, Open Clinical Pharmacology Study of Intravenous Injection of Oncolytic Virus Injection (RT-01) in Patients With Relapsed or Refractory T-cell Lymphoma

Graded according to the NCI CTCAE version 5.0.

The time of maximum RNA peak concentration

First Affiliated Hospital Bengbu Medical College

Deputy Director of Hematology

Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

Nivolumab

Intravenous with or without Intratumoral RT-01 in the treatment of patients with advanced solid tumors combined with or without Nivolumab in the treatment of patients with advanced solid tumors

Intravenous injection of RT-01 with or without Nivolumab

Oncolytic Virus Injection (RT-01）

Peihua Lu, MD

This is a single-arm, open-lable study to determine the safety, tolerability and preliminary efficacy of oncolytic virus injection (RT-01) combined with or without immune checkpoint inhibitors (Nivolumab) in the treatment of patients with advanced solid tumors.

To evaluate the safety, tolerability, efficacy, immunoreactivity, immunogenicity, pharmacokinetics and virus shedding of RT-01 injection given via Intravenous with or without Intratumoral administration combined with immune checkpoint inhibitors Nivolumab in the treatment of patients with advanced solid tumors.

RT-01 Monotherapy and in Combination With Nivolumab in Patients With Advanced Solid Tumors

An Open-label Clinical Study to Evaluate the Safety and Efficacy of Intravenous With and Without Intratumoral Oncolytic Virus Injection (RT-01) Combined With or Without Immune Checkpoint Inhibitors (Nivolumab) in the Treatment of Patients With Advanced Solid Tumors

Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Defined as the highest safety-tolerated dose level where at most one patient out of six experiences dose limiting toxicities (DLT) with the next higher dose level having at least 2 of 6 patients who have experienced DLT.

Proportion of patients in the analysis population who have complete response (CR) or partial response (PR) based on RECIST v1.1 imaging.

Proportion of patients in the analysis population who have complete response (CR), partial response (PR) or stable disease (SD) based on RECIST v1.1 imaging.

Survival time is defined as the time from registration to death due to any cause.

Progression-free survival is defined as the time from registration to the earliest date documentation of disease progression or death due to any cause.

Assessed via quantitative reverse transcriptase polymerase chain reaction.

Wuxi People's Hospital

Mouth and Tooth Diseases

Stomatitis

Vesicular Stomatitis

Immunomodulating Agents

In the first three cycles, the subjects were administered on the first day and the sixth day of each cycle respectively; At the beginning of the fourth cycle, the subjects were administered on the sixth day of each cycle, 14 days a cycle.

PD-1 inhibitor(Toripalimab) Intravenous infusion, once every 2 weeks from the 6th day.

Intravenous injection of Revottack injection combined with PD-1(Toripalimab） inhibitor

Oncolytic Virus Injection（Revottack）+PD-1

Han Zhengxiang, MD

This is a one arm, open clinical pharmacological exploration study initiated by researchers to evaluate the safety and effectiveness of vesicular stomatitis oncolytic virus injection (Revottack) combined with PD-1 inhibitor in patients with advanced malignant solid tumors.

The purpose of this study is to evaluate the safety, tolerability, anti-tumor activity, immunogenicity, immune response, pharmacokinetic (PK) characteristics and shedding characteristics of Revottack injection combined with PD-1 inhibitor in patients with advanced solid tumors.

This is a one arm, open clinical pharmacological exploration study initiated by researchers to evaluate the safety and effectiveness of vesicular stomatitis oncolytic virus injection (Revottack) combined with PD-1 inhibitor in patients with advanced malignant solid tumors.

This study is planned to enroll 6-10 patients with advanced solid tumors. Subjects will receive the administration of revottack and PD-1( Toripalimab)inhibitor at a given time.

The purpose of this study is to evaluate the safety, tolerability, anti-tumor activity, immunogenicity, immune response, pharmacokinetic (PK) characteristics and shedding characteristics of Revottack injection combined with PD-1 inhibitor in patients with advanced solid tumors.

Study on the Treatment of Advanced Malignant Solid Tumor With Revottack and PD-1 Inhibitor

A Clinical Pharmacological Study of Intravenous Administration of Vesicular Stomatitis Oncolytic Virus Injection (Revottack）Combined PD-1 Inhibitor in Patients With Advanced Malignant Solid Tumor

Assess the proportion of patients who achieved complete or partial response

Assess the proportion of patients who achieved complete or partial or stable response

The changes from baseline of Peripheral blood lymphocyte subtypes counts

The concentration of antiviral antibody of Revottack in blood

The rate of subjects with viral RNA in the secretion

The Affiliated Hospital of Xuzhou Medical University

RT-01 will be administered either intravenously or with a combination of intravenously and intratumorally on day 1.

Nivolumab will be administered intravenously every 3 weeks starting on day 5.

Intravenous injection with or without intratumoral injection of a single dose of RT-01 and intravenous infusion of Nivolumab

This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in combination with PD-1 inhibitor (Nivolumab) in patients with advanced solid tumors.

The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01 in combination with PD-1 inhibitor.

This is an investigator initiated , single-arm, open-label study of RT-01 as a single agent given via Intravenous injection（IV）with or without Intratumoral injection（IT） in combination with IV Nivolumab in patients with advanced solid tumors.

This study is planned to enroll 40-50 patients with advanced solid tumors. RT-01 will be administered as a single dose on day 1, Nivolumab will be administered intravenously every 3 weeks starting on day 5.

The purpose of this study is to assess the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01 in combination with PD-1 Inhibitor (Nivolumab).

A Study of Oncolytic Virus Injection (RT-01) in Combination With PD-1 Inhibitor in Patients With Advanced Solid Tumors

A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of Oncolytic Virus Injection (RT-01) in Combination With PD-1 Inhibitor (Nivolumab) in Patients With Advanced Solid Tumors

The concentration of antiviral antibody of RT-01 in blood

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

RT-01 will be administered by intravenously;

Intravenous injection a single dose of RT-01

Zhou huan, MD

This is a single-arm, open-label, clinical pharmacology study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in Patients With Extensive-Stage Small Cell Lung Cancer.

The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01.

This is an investigator initiated , single-arm, open-label clinical pharmacology study of RT-01 as a single agent given via Intravenous injection in Patients With Extensive-Stage Small Cell Lung Cancer.

RT-01 will be administered as a single dose on day 1 in patients with advanced solid tumors. Durvalumab will be administered intravenously every 3 weeks starting on day 5 after RT-1 on day 1 for 4 cycles，then followed by every 4 weeks. This study is planned to enroll 10-20 patients with Extensive-Stage Small Cell Lung Cancer.

Considering the benefits of the subjects, the investigator deems that higher doses can be explored, then a higher-dose cohort will be carried out. The purpose of this study is to assess the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01.

A Study of Oncolytic Virus Injection (RT-01) in Patients With Extensive-Stage Small Cell Lung Cancer

A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of Oncolytic Virus Injection (RT-01) in Patients With Extensive-Stage Small Cell Lung Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intravenous Injection of Oncolytic Virus Injection (RT-01) in Patients With Relapsed or Refractory T-cell Lymphoma	NCT05387226	T-cell Lymphoma Virus Intravenous Inj...	Oncolytic Virus...	18 Years -	First Affiliated Hospital Bengbu Medical College
RT-01 Monotherapy and in Combination With Nivolumab in Patients With Advanced Solid Tumors	NCT05122572	Advanced Solid ...	Oncolytic Virus...	18 Years -	Wuxi People's Hospital
RT-01 Monotherapy and in Combination With Nivolumab in Patients With Advanced Solid Tumors	NCT05122572	Advanced Solid ...	Oncolytic Virus...	18 Years -	Wuxi People's Hospital
Study on the Treatment of Advanced Malignant Solid Tumor With Revottack and PD-1 Inhibitor	NCT05644509	Advanced Solid ...	Oncolytic Virus...	18 Years -	The Affiliated Hospital of Xuzhou Medical University
A Study of Oncolytic Virus Injection (RT-01) in Combination With PD-1 Inhibitor in Patients With Advanced Solid Tumors	NCT05228119	Advanced Solid ...	Oncolytic Virus...	18 Years -	The Affiliated Hospital of Xuzhou Medical University
A Study of Oncolytic Virus Injection (RT-01) in Patients With Extensive-Stage Small Cell Lung Cancer	NCT05205421	Advanced Solid ...	Oncolytic Virus...	18 Years -	First Affiliated Hospital Bengbu Medical College

Spots Global Cancer Trial Database for intravenous injection