Finding studies
Finding studies
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Lead
Barbara Ann Karmanos Cancer Institute
With
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) for 8 intrathecal (IT) injections (via lumbar puncture) of anti-cluster of differentiation (CD)3 × anti-EGFRBi armed activated T cells (aATC) (EGFRBi-armed autologous T cells) given twice per week for 4 weeks in a standard 3+3 dose escalation schema with 0.10, 0.50 and 1.00 × 10\^9 EGFRBi-aATC per IT injection for a total of 0.8, 4.0, and 8.0 × 10\^9 cells, respectively. (Phase I) II. To explore efficacy and confirm the toxicity profile of EGFRBi-aATC. (Phase II) SECONDARY OBJECTIVES: I. Measure immune responses in participants of the phase I/II trial by sequential monitoring of phenotype, interferon gamma (IFN-g) enzyme-linked immunoSpots (EliSpots), anti-glioblastoma (GBM) cytotoxicity of peripheral blood mononuclear cell (PBMC) (direct cytotoxicity against GBM cells) directed at GBM cell lines, T-helper 1 (Th1)/T-helper 2 (Th2) serum cytokine patterns, and anti-glioma antibodies in the cerebrospinal fluid (CSF)/serum during the "vaccinate and consolidate" process. II. Assess survival and persistence of aATC in the CSF, and trafficking of IT-injected aATC out of the CSF into the bloodstream. III. Image patients' brain with magnetic resonance imaging (MRI) (performed clinically in 2-month intervals; includes standard structural sequences and perfusion imaging) and alpha-\[11C\]methyl-L-tryptophan (AMT) positron emission tomography (PET) scan (under Wayne State University \[WSU\] Internal Review Board \[IRB\]/Karmanos Cancer Institute \[KCI\]-approved research protocol) before and after the aATC treatment regimen. OUTLINE: This is a phase I dose-escalation study followed by a phase II study. PHASE I: Patients receive EGFRBi-armed autologous T cells IT twice weekly for 4 weeks. PHASE II: Patients receive EGFRBi-armed autologous T cells\* IT twice weekly for 4 weeks and then intravenously (IV) over 15-30 minutes twice weekly for 2 weeks. \*NOTE: Six selected patients receive EGFRBi-armed autologous T cells IV on day -3, -2, or -1 prior to first IT infusion. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months thereafter.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
