Trials / Completed
CompletedNCT05694364
Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies
A Phase 1/1b Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to find out if an investigational drug called PRGN-3007 UltraCAR-T cells (PRGN-3007 T cells) can help people with ROR1-positive hematologic chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL) and solid tumor triple negative breast cancer (TNBC) malignancies.
Conditions
- Chronic Lymphocytic Leukemia
- Mantle Cell Lymphoma
- Acute Lymphoblastic Leukemia
- Diffuse Large B Cell Lymphoma
- Triple Negative Breast Cancer Malignancies
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fludarabine | Fludarabine is an antimetabolite given prior to lymphodepletion. |
| DRUG | Cyclophosphamide | Cyclophosphamide is a nitrogen mustard-derivative, polyfunctional alkylating agent given prior to lymphodepletion. |
| BIOLOGICAL | PRGN-3007 | PRGN-3007 T cells are autologous T cells that are genetically modified ex vivo with the Sleeping Beauty (SB) system to express a ROR1-specific chimeric antigen receptor (ROR1 CAR), membrane bound interleukin-15 (mbIL15), a kill switch derived from truncated form of human epidermal growth factor receptor (HER1t) and include a built-in mechanism for intrinsic downregulation of programmed cell death receptor 1 (PD-1) expression on UltraCAR-T cells.The transgenes are delivered from a SB transposon which ensures co-expression all transgenes in all transfected cells. T cells are selected from the apheresis product and can be modified with the SB system to manufacture the T cells with the potential of infusing within 2 days from genetic modification. |
Timeline
- Start date
- 2023-01-25
- Primary completion
- 2024-04-18
- Completion
- 2024-04-18
- First posted
- 2023-01-23
- Last updated
- 2026-02-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05694364. Inclusion in this directory is not an endorsement.