Glioblastoma Multiforme Clinical Trial
Official title:
Immunogene-modified Antigen-specific T (IgT) Cells for the Treatment of Glioblastoma Multiforme
Verified date | January 2023 |
Source | Shenzhen Geno-Immune Medical Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 20 |
Est. completion date | December 31, 2023 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 80 Years |
Eligibility | Inclusion Criteria: 1. abilities to understand and the willingness to provide written informed consent; 2. patients are = 1 and = 80 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. Malignant cells are target antigen positive confirmed by immunostaining, quantitative PCR or sequencing; 5. karnofsky performance score (KPS) = 60; 6. life expectancy >3 months; 7. 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; 8. peripheral blood absolute lymphocyte count must be above 0.8×10^9/L; 9. satisfactory heart functions; 10. patients must be willing to follow the orders of doctors; 11. 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 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. |
Country | Name | City | State |
---|---|---|---|
China | Shenzhen Geno-immune Medical Institute | Shenzhen | Guangdong |
China | Shenzhen People's Hospital | Shenzhen | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Shenzhen Geno-Immune Medical Institute |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | incidents of treatment related adverse events as assessed by CTCAE V4.0. | 2 years | |
Secondary | Treatment response rate of recurrent glioblastoma | Defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD). | 6 months | |
Secondary | Overall survival Rate | Percentage of participants with objective response as determined by the investigator based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) | 2 years | |
Secondary | Progression-free survival rate | Progression-free Survival (PFS) as determined by the investigator based on RECIST v1.1 | 2 years | |
Secondary | Persistence and proliferation of IgT cells in patients | IgT cell percentage in the peripheral blood by flow cytometry or qPCR | 2 years | |
Secondary | Production of specific immune check point modulatory proteins | Specific immune modulators in peripheral blood will be measured by ELISA | 2 years |
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