NCT05694364

A Phase 1/1b Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies

Study 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.

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Interventions

FludarabineDRUG
Fludarabine is an antimetabolite given prior to lymphodepletion.
CyclophosphamideDRUG
Cyclophosphamide is a nitrogen mustard-derivative, polyfunctional alkylating agent given prior to lymphodepletion.
PRGN-3007BIOLOGICAL
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.

Study Locations

FacilityCityStateCountry
Moffitt Cancer CenterTampaFloridaUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026