Intravenous Injection of Oncolytic Virus Injection (RT-01) in Patients With Relapsed or Refractory T-cell Lymphoma
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Oncolytic Virus Injection(RT-01) RT-01 will be administered intravenously |
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)
|
Outcome Measures
Primary Outcome Measures
- Incidence of adverse events [Up to 6 months]
Graded according to the NCI CTCAE version 5.0.
- To evaluate objective Response Rate (ORR) of the antitumor activity [Up to 2 years]
To assessed per Lugano and Lyric
- To evaluate the disease control rate (DCR) of the antitumor activity [Up to 2 years]
To assessed per Lugano and Lyric
- The changes of the immunoreactivity during treatment [Up to 28 days]
Peripheral blood T lymphocyte subtype
- To evaluate the immunogenicity of RT-01 [Up to 28 days]
Antiviral antibody
- To evaluate the viral shedding of RT-01 [8 weeks after last dose]
Viral RNA
- The Cmax of Viral RNA [8 weeks after last dose]
The maximum RNA peak concentration
- The Tmax of Viral RNA [8 weeks after last dose]
The time of maximum RNA peak concentration
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female aged ≥ 18 years.
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The following of typesRelapsed T-cell lymphoma (TCL): peripheral T-cell lymphoma (PTCL) [peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell (ALCL)], and cutaneous TCL (CTCL) of mycosis fungoides (MF).
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Patients have received at least 1-line systemic treatment in the past and who have relapsed or are refractory: failed to achieve complete remission (CR) or disease progression (PD) after CR, ineligible for autologous hematopoietic stem cell transplantation (ASCT) or PD after ASCT.
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There is at least one measurable lesion without previous local treatment, which the long axis of the intranodal lesion is >15 mm or extranodal lesion >10 mm According to Lugano 2014 criteria.
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Patients Eastern Cooperative Oncology Group (ECOG) physical status score must be 0 or
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Life expectancy≥3 months et al.
Exclusion Criteria:
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Subjects with brain metastasis and/or clinically history tumor brain of metastasis;
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Subjects who have received anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc within 2 weeks before RT-01 administration;
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Subjects who have participate in another interventional study within 4 weeks before RT-01 administration;
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Subjects who have had major surgery within 4 weeks before RT-01 administration.
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Patients in any condition requiring systemic treatment with corticosteroids (prednisone > 10 mg/day or equivalent of the similar drug) or other immunosuppressive agents within 14 days before RT-01 administration, but currently or previously treated with any of the following steroid regimens, were included: Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption; Prophylactic short-term use of corticosteroids;
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Subjects who have participate in another oncolytic virus study within 8 weeks before RT-01 administration;
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Subjects received live vaccines within 7 days before RT-01 administration;
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Subjects received Antiviral drugs within 2 weeks, long-acting interferon within 4 weeks before RT-01 administration# 9.Subjects with adverse reactions caused by previous anti-tumor treatment not recovered to (CTCAE 5.0) grade 1 (except alopecia);
10.Subjects who have uncontrolled active infection; 11.Subjects with known positive history of human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); 12.Subjects who have active hepatitis; 13.Subjects who have serious cardiovascular system disorders history; 14.Clinically uncontrollable third space effusion,are considered unsuitable for this study in the opinion of the investigator; 15.Subjects with active autoimmune diseases or history of autoimmune diseases that may relapse; et al.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- First Affiliated Hospital Bengbu Medical College
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LWY21076CBY3