NCT05387226

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: The First Affiliated Hospital of Bengbu Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• T-cell Lymphoma
• Virus
• Intravenous Injection

Interventions

Type	Name	Description
BIOLOGICAL	Oncolytic Virus Injection(RT-01)	RT-01 will be administered intravenously on day 1 and 6, and every 8 weeks thereafter (up to 6 times)

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2022-05-24
• Last updated: 2022-05-24