Treatment of Children CD19+ Leukemia and Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell Therapy
NCT03910842 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2019-09-06
Summary
This is a single arm, open-label, early phase Ⅰ study, to determine the safety and efficacy of CD19-TriCAR-T and CD19-TriCAR-SILK cell therapy in Children CD19+ Leukemia Non-Hodgkin lymphoma treatment.
Conditions
- Non-Hodgkin Lymphoma of Intestine
- Leukemia
Interventions
- BIOLOGICAL
-
CD19-TriCAR-T/SILK
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide may be administered, followed by a single infusion of CD19-TriCAR-T cells or 4 repeat infusions of CD19-TriCAR-SILK cells.
Sponsors & Collaborators
-
Hunan Provincial People's Hospital
collaborator OTHER -
Timmune Biotech Inc.
lead INDUSTRY
Principal Investigators
-
Xiangling He · Hunan Provincial People's Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-21
- Primary Completion
- 2022-04-15
- Completion
- 2022-10-15
Countries
- China
Study Locations
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