Immunogene-modified T (IgT) Cells Against Glioblastoma Multiforme

Trial number:
NCT03170141
Trial phase:
1
Study type:
Immunotherapy, Supportive interventions
Overall status:
Enrolling by invitation

Study start date

May, 2020

Scientific title

Immunogene-modified Antigen-specific T (IgT) Cells for the Treatment of Glioblastoma Multiforme

Summary

This study aims to treat patients who have been diagnosed with brain cancer including glioblastoma multiforme (GBM). 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 antigen-specific T cells. Thus, in this study, the gene-modified T cells specific for GBM antigens will be combined with immune modulatory genes to treat patients in dose escalation cohorts.

abilities to understand and the willingness to provide written informed consent;patients are ≥ 1 and ≤ 80 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; Malignant cells are target antigen positive confirmed by immunostaining, quantitative PCR or sequencing; 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; patients must be willing to follow the orders of doctors; women of reproductive potential (between 15 and 49 years old) must have a negative pregnancy test within 7 days of study start. Male and female patients of reproductive potential must agree to use birth control during the study and 3 months post study.

Study design

Primary purpose: Treatment, Allocation: N/A, Intervention model: Single Group Assignment, Intervention model description: Patients with GBM will be treated with tumor targeting IgT cells expressing immune modulatory genes, Masking: None (Open Label),

Conditions

Glioblastoma Multiforme of Brain, Glioblastoma Multiforme

Other study ID numbers

GIMI-IRB-17003

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