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

NCT05387226 | Unknown Phase 1

• 1 other identifier: LWY21076CBY3
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

T-cell Lymphoma; Virus; Intravenous Injection

Outcome Measures

Primary Outcomes (8)

• Incidence of adverse events

  Graded according to the NCI CTCAE version 5.0.

  Up to 6 months

• To evaluate objective Response Rate (ORR) of the antitumor activity

  To assessed per Lugano and Lyric

  Up to 2 years

• To evaluate the disease control rate (DCR) of the antitumor activity

  To assessed per Lugano and Lyric

  Up to 2 years

• The changes of the immunoreactivity during treatment

  Peripheral blood T lymphocyte subtype

  Up to 28 days

• To evaluate the immunogenicity of RT-01

  Antiviral antibody

  Up to 28 days

• To evaluate the viral shedding of RT-01

  Viral RNA

  8 weeks after last dose

• The Cmax of Viral RNA

  The maximum RNA peak concentration

  8 weeks after last dose

• The Tmax of Viral RNA

  The time of maximum RNA peak concentration

  8 weeks after last dose

Study Arms (1)

Oncolytic Virus Injection(RT-01)

EXPERIMENTAL

RT-01 will be administered intravenously

Biological: Oncolytic Virus Injection(RT-01)

Interventions

Oncolytic Virus Injection(RT-01) BIOLOGICAL

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥ 18 years.
• 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).
• 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.
• 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.
• Patients Eastern Cooperative Oncology Group (ECOG) physical status score must be 0 or 1.
• Life expectancy≥3 months et al.

You may not qualify if:

• Subjects with brain metastasis and/or clinically history tumor brain of metastasis;
• 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;
• Subjects who have participate in another interventional study within 4 weeks before RT-01 administration;
• Subjects who have had major surgery within 4 weeks before RT-01 administration.
• 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;
• Subjects who have participate in another oncolytic virus study within 8 weeks before RT-01 administration;
• Subjects received live vaccines within 7 days before RT-01 administration;
• 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);
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Bengbu Medical University: lead

MeSH Terms

Conditions

Lymphoma, T-Cell; Virus Diseases

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Infections

Central Study Contacts

zhou huan, MD

CONTACT

13665527160; zhouhuanbest@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Hematology

Study Record Dates

• First Submitted: May 7, 2022
• First Posted: May 24, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share