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NCT03170141TerminatedPhase 1

Immunogene-modified T (IgT) Cells Against Glioblastoma Multiforme

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

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
30 (actual)
First submitted
25 May 2017
Start date
31 May 2017
Primary completion date
1 Jul 2026
Lead sponsor
Shenzhen Geno-Immune Medical Institute
NCT number
NCT03170141

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • a prior history of gliadel implantation 4 weeks before this study start or currently receiving antibody based therapies;

Other illness

  • HIV positive;
  • tuberculosis infection not under control;
  • history of autoimmune disease, or other diseases require long-term administration of steroids or immunosuppressive therapies;
  • history of allergic disease, or allergy to immune cells or study product excipients;

Other

  • patients already enrolled in other immune cell clinical study;
  • patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Who the study is looking for

  • 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;
  • patients must be willing to follow the instructions 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.

Age in the registry: 6 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Shenzhen Geno-immune Medical InstituteShenzhenChinaUnknown status

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