Treatment of Advanced Solid Tumors With Neo-T(GI-NeoT-02)
NCT05798546 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2023-04-04
Summary
The primary objective of this study is to evaluate the safety of Neo-T in the treatment of advanced solid tumors.
The secondary objective of this study is to evaluate preliminarily the effect of Neo-T in the treatment of advanced solid tumors.
Conditions
Interventions
- BIOLOGICAL
-
Neo-T
Patients will recive Neo-T iv on day 0. Three times of cell infusion with an interval of 7 days constitute a cycle,maximum four cycles of treatment for patients.
- DRUG
-
Cyclophosphamide 500 mg/m2/day iv on day-5 for one day.
- DRUG
-
Fludarabine 25 mg/m2/day iv on day-5 and day-4 for two days.
- DRUG
-
Interleukin-2
500,000IU/m2 SC,after each cell infusion,IL-2 will start within 24 hours and every 8-12 hours for up to 6 doses.
Sponsors & Collaborators
-
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
collaborator OTHER -
BGI, China
lead OTHER
Principal Investigators
-
Jing Chen, Doctor · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-28
- Primary Completion
- 2023-09-30
- Completion
- 2024-09-30
Countries
- China
Study Locations
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