Immunogene-modified T (IgT) Cells Against Glioblastoma Multiforme

Launched by SHENZHEN GENO-IMMUNE MEDICAL INSTITUTE · May 25, 2017

Keywords

ClinConnect Summary

Background:

Glioblastoma multiforme (GBM) is the most dangerous and aggressive form of brain cancer. Chimeric antigen receptor (CAR)-modified T cells have been shown to mediate long-term durable remissions in recurrent or refractory hematopoietic malignancies, and thus the CAR-T therapy approach is also considered a promising treatment against GBM. Some surface antigens such as GD2 and CD56 have been targeted as potential GBM antigens. In addition, certain antigens are highly specific in GBM, such as epidermal growth factor receptor variant EGFRviii and metastasis related antigen CD44v6.

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. abilities to understand and the willingness to provide written informed consent;
• • 2. patients are ≥ 6 and ≤ 70 years old;
• • 3. 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;
• • 4. karnofsky performance score (KPS) ≥ 60;
• • 5. life expectancy \>3 months;
• • 6. 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;
• • 7. peripheral blood absolute lymphocyte count must be above 0.8×10\^9/L;
• • 8. satisfactory heart functions;
• • 9. patients must be willing to follow the instructions of doctors;
• • 10. 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.
• Exclusion Criteria:
• • 1. a prior history of gliadel implantation 4 weeks before this study start or currently receiving antibody based therapies;
• • 2. HIV positive;
• • 3. tuberculosis infection not under control;
• • 4. history of autoimmune disease, or other diseases require long-term administration of steroids or immunosuppressive therapies;
• • 5. history of allergic disease, or allergy to immune cells or study product excipients;
• • 6. patients already enrolled in other immune cell clinical study;
• • 7. patients, in the opinion of investigators, may not be eligible or not able to comply with the study.