A Clinical Study to Observe the Safety and Efficacy of ScTIL210 in the Treatment of Malignant Solid Tumors
NCT04571892 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2023-04-12
Summary
An open-label, single-arm, single-dose escalation and multiple-dose expansion clinical study of cell therapy to observe and to evaluate the tolerance, the pharmacokinetic characteristics, the safety, and the efficacy of ScTIL210 in the treatment of malignant
Conditions
- Malignant Solid Tumor
Interventions
- BIOLOGICAL
-
Super circulating tumor infiltrating lymphocytes(ScTIL)
Peripheral blood mononuclear cells (PBMCs) are used for cell preparation. PD-1(programmed death 1) positive T cells are isolated from peripheral blood by blood cell apheresis method and transduced with lentivirus loaded with "enhanced receptor" and "superamplification factor". The obtained ScTIL is used for one-time intravenous infusion.
Sponsors & Collaborators
-
Shanghai East Hospital
lead OTHER
Principal Investigators
-
Jin Li, Ph.D. · Shanghai Oriental Hospital
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
- 2020-10-15
- Primary Completion
- 2023-12-31
- Completion
- 2024-12-31
Countries
- China
Study Locations
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