Immunogene-modified T (IgT) Cells Against Glioblastoma Multiforme (NCT03170141) | Clinical Trial Compass
By InvitationPhase 1
Immunogene-modified T (IgT) Cells Against Glioblastoma Multiforme
China30 participantsStarted 2017-05-31
Plain-language summary
This study aims to treat patients who have been diagnosed with brain cancer glioblastoma multiforme (GBM) including diffuse intrinsic pontine glioma (DIPG) and diffuse midline glioma (DMG). The treatment combines two different approaches to fight cancer: immune modulators and antigen-specific T cells. Immune checkpoint antibodies have been tested on various tumors with good outcomes. GBM is known to express increased levels of certain antigens that can be targeted by T cells including chimeric antigen receptor-modified T (CAR-T) cells and tumor antigen specific cytotoxic lymphocytes (CTLs). In this study, the gene-modified T cells specific for GBM antigens will be combined with immune modulatory gene-modified dendritic cells (DCs) as individualized treatment regimens to treat patients.
Who can participate
Age range6 Years – 70 Years
SexALL
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Inclusion criteria
✓. abilities to understand and the willingness to provide written informed consent;
✓. patients are ≥ 6 and ≤ 70 years old;
✓. recurrent glioblastoma or brain tumor patients with measurable tumors. Patients have received standard care of medication, such as gross total resection with concurrent radio-chemotherapy (\~54 - 60 Gy, TMZ). Patients must either not be receiving dexamethasone or receiving ≤ 4 mg/day at the time of leukopheresis;
✓. karnofsky performance score (KPS) ≥ 60;
✓. life expectancy \>3 months;
✓. satisfactory bone marrow, liver and kidney functions as defined by the following: absolute neutrophile count ≥ 1500/mm\^3; hemoglobin \> 10 g/dL; platelets \> 100000 /mm\^3; Bilirubin \< 1.5×ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5×ULN; creatinine \< 1.5×ULN;
✓. peripheral blood absolute lymphocyte count must be above 0.8×10\^9/L;
✓. satisfactory heart functions;
Exclusion criteria
What they're measuring
1
Safety of infusion of autologous IgT cells with cyclophosphamide and fludarabine as lymphodepleting chemotherapy in patients with recurrent glioblastoma using the NCI CTCAE V4.0 criteria.