The primary objective of this study is to evaluate the safety and clinical activity of NKG2D-based CAR-T cells infusion in the treatment of relapsed/refractory NKG2DL+ solid tumors.
The preclinical study clarified that NKG2D-based CAR-T cells showed strong cytotoxicity against NKG2DL+ cell lines in vitro as well as a therapeutic effect against NKG2DL+ cell xenografts in vivo. In addition, the data also demonstrated the safety of NKG2D-based CAR-T therapy. NKG2D-based CART represent a potentially effective and safety therapeutic approach for patient with relapsed/refractory NKG2DL+ solid tumors. In this trial, the investigators researched the safety of administering NKG2D-based CAR-T which generated with CD8 hinge region and transmembrane region, 4-1BB costimulatory region and CD3 zeta region. The investigators also assessed that disease response was determined within the context of a phase I trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Autologous genetically modified anti-NKG2DLs CAR transduced T cells
Xunyang Changchun Shihua Hospital
Jiujiang, Jiangxi, China
RECRUITINGNumber of participants with treatment-related adverse events as assessed by CTCAE v4.0
The number of patiens who suffered ≥ 3 grade toxicities according to the CTCAE criteria after CAR-T therapy.
Time frame: through study completion, an average of 3 months.
Detailed adverse events post NKG2D-based CAR-T therapy.
The events included infusion reactions, CRS, tumor lysis syndrome and hematological toxicity. The criteria mainly reffered to guidelines for immune related adverse reactions.
Time frame: through study completion, an average of 3 months.
overall survival (OS)
For all subjects, overall survival refers to the period from being included in the test group to death caused by any reason
Time frame: 2 years post infusion
Progress Free Survival (PFS)
Progress Free Survival after administration
Time frame: 2 years post infusion
Partial response rate
According the RECISE 1.1 criteria, as to the measurable primary lesions, we measure the long and short diameter. As to unmeasurable primary leisons, we measure the measurable metastatic lesions.
Time frame: through study completion, an average of 3 months.
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