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 CAR-T 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
Autologous genetically modified anti-NKG2DLs CAR transduced T cells
Affiliated hospital of jiujiang university
Jiujiang, Jiangxi, China
Number of Participants with severe cytokine release syndrome(CRS) as a Measure of Safety and Tolerability.
The severe CRS post KD-025 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined.
Time frame: 0 to 28 days post infusion
Copies numbers of CAR
Copies numbers of CAR in peripheral blood (PB)
Time frame: 1 year post infusion
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
Duration of response, (DoR)
Time frame: 2 years post infusion
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