Malignant melanoma have been reported to be characterized with high gp100 expression. Patients' autologous T cells will be isolated and transduced by GPA-TriMAR lentivirus to generate the GPA-TriMAR-T cells. When infused back to the patient, the GPA-TriMAR-T cells will recognize and kill target cells that express gp100(209-217) peptides in the form MHC-I complex, thus eliminating malignant melanoma from the body.
GPA-TriMAR is a modified chimeric antigen receptor (CAR) that consist of three subunit in it's outer membrane domain. The outer membrane domain linked to the inner membrane 4-1BB/CD3ζ domain through the transmembrane domain, thus compose the complete chimeric antigen receptor. Patients' autologous T cells will be isolated and transduced by GPA-TriMAR lentivirus to generate the GPA-TriMAR-T cells. When infused back to the patient, the modified GPA-TriMAR-T cells will recognize and kill malignant melanoma cells in the body, and in the meanwhile the other two subunits function to stimulate the innate immune system and enhance GPA-TriMAR-T cells tumor Infiltration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Patients will undergo leukapheresis to isolate autologous T cells, these T cells will be activated and modified to express GPA-TriMAR in the manufacture facility, and eventually infused back into the body for treatment.
Hainan Cancer Hospital
Haikou, Hainan, China
RECRUITINGThe Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
RECRUITINGsafety (Incidence of treatment-related adverse events as assessed by CTCAE v4.03)
Incidence of treatment-related adverse events as assessed by CTCAE v4.03
Time frame: 24 months
Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria)
Complete response rate per the revised International Working Group (IWG) Response Criteria
Time frame: 24 months
Partial response rate [PR] (Partial response rate per the revised International Working Group (IWG) Response Criteria)
Partial response rate per the revised International Working Group (IWG) Response Criteria
Time frame: 24 months
Duration of Response (The time from response to relapse or progression)
The time from response to relapse or progression
Time frame: 24 months
Progression Free Survival (The time from the first day of treatment to the date on which disease progresses.)
The time from the first day of treatment to the date on which disease progresses.
Time frame: 24 months
Overall Survival (The number of patient alive, with or without signs of cancer)
The number of patient alive, with or without signs of cancer
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.