RPM CD19-mbIL15-CAR-T Cells in Patient With Advanced Lymphoid Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Diffuse Large B Cell Lymphoma
- Follicular Lymphoma
- High Grade B Cell Lymphoma
- Mantle Cell Lymphoma
- Non-Hodgkin's Lymphoma Refractory
- Non-Hodgkin's Lymphoma, Relapsed
- Primary Mediastinal Large B Cell Lymphoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: 3+3 dose escalationMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 75 years
- Gender
- Both males and females
Description
This is an open-label Phase 1 study to determine the feasibility, safety, and the recommended maximum tolerated Dose (MTD) of a single infusion of RPM CD19 mbIL15 CAR-T cells for adult patients. Approximately 24 subjects will be enrolled and it is anticipated approximately 16 subjects will be infuse...
This is an open-label Phase 1 study to determine the feasibility, safety, and the recommended maximum tolerated Dose (MTD) of a single infusion of RPM CD19 mbIL15 CAR-T cells for adult patients. Approximately 24 subjects will be enrolled and it is anticipated approximately 16 subjects will be infused at the varied doses of T cells. This study will very rapidly administer T cells that are genetically modified by electroporation using DNA plasmids from the SB system to co-express CD19RCD8CD28 (the CAR), mbIL15, and HER1t. The presence of mbIL15 may allow for reduced doses of CAR-T cells to be infused to reduce the risk for adverse events, such as cytokine release syndrome (CRS). The key features of study design are listed below. Uncontrolled Blinding: open-label Randomized: no Duration of treatment: single infusion within day Titration: none Single center, Taiwan
Tracking Information
- NCT #
- NCT04844086
- Collaborators
- National Taiwan University Hospital
- Investigators
- Principal Investigator: Shangru Wu, PhD National Taiwan University Hospital
Get Well Soon