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Immunogene-modified T (IgT) Cells Treatment of Glioblastoma Multiforme

Phase I Clinical Trial

 

Glioblastoma is the most dangerous and aggressive form of malignant brain tumor among adults. Glioblastomas are biologically aggressive tumors and are challenging to treat because of the presence of tumors in a very specific area of the brain, its intrinsic resistance to the most-commonly accepted therapy, and the quick migration of malignant cells into neighboring brain tissues.

Chimeric antigen receptor (CAR)-modified T cells have been shown to mediate long-term durable remissions in recurrent or refractory B cell malignancies, and thus the CAR-T therapy approach is considered a promising treatment against Glioblastoma. This trial aims to infuse antigen-specific T cells modified with immune modulatory genes (IgT). Combination of tumor targeting and immune modulatory activities, the IgT cells could target both the tumor cells and the tumor microenvironment.

Phase I Open Clinical Trial 

Through both our partner hospital in Beijing and the trial sponsor, Shenzhen Geno-immune Medical Institute, Global Healthcare Direct provides access to the clinical trial recruitment process. 

Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 20 participants
Intervention Model Description:    Patients with Glioblastoma will be treated with tumor targeting IgT cells expressing immune modulatory genes
Masking: Open-label trial
Primary Purpose: Treatment

How to apply for the Glioblastoma CAR-T trial?

Fill in the below form. Add a short description of your case history and of your current condition. Our case manager will contact you shortly and guide you through.

Choosing to participate in a phase 1 medical trial is an important personal decision.

Talk with your doctors and family members or friends about deciding to join a study!

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Treatment regimen

Patients will receive non-myeloablative chemotherapy, followed by intravenous infusion of autologous IgT cells. A standard 3+3 escalation approach will be used to obtain the safe dosage of IgT cells. The tested IgT cell dosage ranges from 1×10^5 /kg to 1×10^7 /kg

Tumor antigen-specific IgT cells are infused intravenously or directly to the tumor location of the patients in a three-day split-dose regimen(day 0,10%; day1, 30%; day2, 60%)to complete a total targeted dose.

Eligibility Criteria

  • Abilities to understand and the willingness to provide written informed consent;

  • Patients are ≥ 18 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).

  • Malignant cells are target antigen positive confirmed by immunostaining, quantitative PCR or sequencing;

  • Karnofsky performance score (KPS) ≥ 60 /  ECOG grade 2 or lower

  • 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 trial start. Male and female patients of reproductive potential must agree to use birth control during the trial and 3 months post trial.

Exclusion Criteria

  • Karnofsky/jansky score of 50% or lower / ECOG grade 3 or higher

  • 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 trial product excipients;

  • Patients already enrolled in other immune cell clinical trial;

  • Patients, in the opinion of investigators, may not be eligible or not able to comply with the trial.

Et après ?

 

1.Contactez-nous: remplissez ce formulaire, envoyez un email ou appelez-nous.

2.Notre responsable de cas vous enverra un questionnaire sur les essais hospitaliers et vous assistera avec tous les documents médicaux nécessaires.

3.Nous vérifierons toutes les options et vous fournirons les plans de traitement et les prix. Nous vous aiderons à choisir la meilleure option.

4.Sur demande, nous pouvons vous aider à organiser vos vols et votre hébergement.

5.Notre accompagnateur personnel vous attendra à la porte des arrivées et vous accompagnera tout au long de votre traitement.

6.Nous vous ferons parvenir les documents de sortie traduits et resterons en contact avec vous après votre départ.

 

Toujours là pour vous,

L'équipe GHD

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