Cancer Type: Malignant Hematology
Study Type: Treatment
Phase: Phase I
Principal Investigator: Pinilla-Ibarz, Javier
A Phase 1/1b Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients with Advanced Hematologic and Solid Tumor Malignancies
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.
Primary Objectives: Phase I: To determine the MTD of PRGN-3007 in subjects with advanced ROR1+ hematologic malignancies and solid tumors Phase Ib: To evaluate the safety of PRGN-3007 administered at the MTD to subjects with advanced ROR1+ hematologic malignancies and solid tumors Secondary Objectives: -To determine the ORR and DCR in subjects with advanced ROR1+ hematologic malignancies and solid tumors following PRGN-3007 infusion using the assessments and criteria appropriate for their disease -To evaluate expansion and persistence of PRGN-3007 in blood and at the tumor site for 12 months following the initial dose of PRGN-3007 -To evaluate the time to onset and duration of response in subjects with a confirmed response Exploratory Objectives: -To characterize expression of cytokines and biomarkers in blood and tissue samples collected pre- and post-treatment with PRGN-3007 -To characterize changes in immune phenotype pre- and post-treatment PRGN-3007 -To examine minimal residual disease (MRD) in subjects that experience a response to PRGN-3007 infusion -To compare PRGN-3007 expression in blood and tumor following different lymphodepletion regimen
Cell Therapy; Chemotherapy (NOS); Therapy (NOS)
Cetuximab (); Erbitux (Cetuximab); PRGN-3007 (); Tocilizumab (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
Key Inclusion Criteria:
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