Status:
UNKNOWN
Intravenous Injection of Oncolytic Virus Injection (RT-01) in Patients With Relapsed or Refractory T-cell Lymphoma
Lead Sponsor:
The First Affiliated Hospital of Bengbu Medical University
Conditions:
T-cell Lymphoma
Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 o...
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 da...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05387226
Start Date
May 1 2022
End Date
December 1 2023
Last Update
May 24 2022
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