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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
RT-01 will be administered intravenously on day 1 and 6, and every 8 weeks thereafter (up to 6 times)
Incidence of adverse events
Graded according to the NCI CTCAE version 5.0.
Time frame: Up to 6 months
To evaluate objective Response Rate (ORR) of the antitumor activity
To assessed per Lugano and Lyric
Time frame: Up to 2 years
To evaluate the disease control rate (DCR) of the antitumor activity
To assessed per Lugano and Lyric
Time frame: Up to 2 years
The changes of the immunoreactivity during treatment
Peripheral blood T lymphocyte subtype
Time frame: Up to 28 days
To evaluate the immunogenicity of RT-01
Antiviral antibody
Time frame: Up to 28 days
To evaluate the viral shedding of RT-01
Viral RNA
Time frame: 8 weeks after last dose
The Cmax of Viral RNA
The maximum RNA peak concentration
Time frame: 8 weeks after last dose
The Tmax of Viral RNA
The time of maximum RNA peak concentration
Time frame: 8 weeks after last dose
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