Chimeric antigen receptor T cells (CAR-T) therapy has not yet been fully explored in solid tumors. Human epidermal growth factor receptor-2(HER2) is widely expressed in cancers. Investigators have developed anti-HER2 CAR-modified T cells and validated the efficiency targeting HER2-positive cancer in preclinical studies. This study is aimed to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, CAR-T cells persistence, tumor elimination and disease status after treatment will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
HER-2-targeting CAR-T cells infusion in HER2 positive cancers
Southwest Hospital of Third Millitary Medical University
Chongqing, Chongqing Municipality, China
Determine the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Observe and handle the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Time frame: 3 years
Survival time of Anti-HER2 CAR T cells in vivo.
Detect the existence of CAR-T cells in the blood of participants through qPCR or flow cytometry.
Time frame: 1 year
Efficacy of anti-HER2 CAR T cells to confirm the ability of CAR T cells to eliminate HER2 positive cancer cells
Evaluate the anti-tumor efficacy of CAR-T therapy by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 and Immune-Related Response Criteria(iRECIST).
Time frame: 12 weeks
Maximum tolerated dose (MTD) of HER2 targeted CAR T cells
Determine the maximum tolerated dose of each participant through the grades of side effects.
Time frame: 4 weeks
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