T-cell Lymphoma
Conditions
Interventions
Sponsors
First Affiliated Hospital Bengbu Medical College REC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The age at the time of signing the informed consent is = 18 years old, regardless of gender; 2. According to the WHO classification standard revised in 2017, the following subtypes were confirmed: peripheral T-cell lymphoma (PTCL) [non-specific type (PTCL-NOS), vascular immunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL)] and cutaneous T-cell lymphoma (CTCL) of mycosis fungoides (MF); 3. Those who are ineffective or relapse after at least one or more treatments: treatment fails to achieve complete remission (CR) or disease progression (PD) occurs after reaching CR, patients are not suitable for receiving autologous hematopoietic stem cell transplantation (ASCT) or PD occurs after receiving ASCT; 4. According to Lugano 2014 standard, there is at least one measurable lesion without local treatment in the past, and the longest diameter of the measurable tumor lesion is more than 15mm in the node, or more than 10mm in the extranode; 5. ECOG physical strength score 0-1; 6. Expected life of at least 3 months.
Exclusion criteria
Exclusion criteria: 1.Subjects with brain metastasis and/or clinically history tumor brain of metastasis; 2.Subjects who have received anti-tumor therapy such as chamotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc within 2 weeks before RT-01 administration; 3.Subjects who have participate in another interventional study within 4 weeks before RT-01 administration; 4.Subjects who have had major surgery within 4 weeks before RT-01 administration. 5.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; 6.Subjects who have participate in another oncolytic virus study within 8 weeks before RT-01 administration; 7.Subjects receivd live vaccines within 7 days before RT-01 administration; 8.Subjects receivd 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event, AE;Objective remission rate, ORR;Disease control rate, DRR;Progression Free Survival, PFS;Overall Survival, OS; | — |
Countries
China
Contacts
Public ContactZhangfeng
First Affiliated Hospital Bengbu Medical College
Outcome results
None listed