Trials / Terminated
TerminatedNCT04844086
RPM CD19-mbIL15-CAR-T Cells in Patient With Advanced Lymphoid Malignancies
Infusion of CD19-Specific Chimeric Antigen Receptor T-cells Produced by Rapid Personalized Manufacture for Patients With Advanced Lymphoid Malignancies
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Eden BioCell Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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 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. 1. Uncontrolled 2. Blinding: open-label 3. Randomized: no 4. Duration of treatment: single infusion within day 5. Titration: none 6. Single center, Taiwan
Conditions
- B-cell Acute Lymphoblastic Leukemia
- Non-Hodgkin's Lymphoma, Relapsed
- Non-Hodgkin's Lymphoma Refractory
- Primary Mediastinal Large B Cell Lymphoma
- Diffuse Large B Cell Lymphoma
- Follicular Lymphoma
- Mantle Cell Lymphoma
- High-grade B-cell Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RPM CD19-mbIL15-CAR-T cells | Single dose of RPM CD19-mbIL15-CAR-T cells will be infused, and a standard "3+3" design will be applied. Drug: Fludarabine Fludarabine is used for lymphodepletion. Drug: Cyclophosphamide Cyclophosphamide is used for lymphodepletion |
Timeline
- Start date
- 2021-03-02
- Primary completion
- 2022-05-12
- Completion
- 2022-05-12
- First posted
- 2021-04-14
- Last updated
- 2022-05-18
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT04844086. Inclusion in this directory is not an endorsement.