It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-Trop2 U-CAR-NK Cells Therapy combined with Chemotherapy for Relapsed/Refractory Non-Small Cell Lung Cancer (NSCLC).
Who can participate? Patients who were diagnosed with Non-Small Cell Lung Cancer and tumor cells expressing Trop2. How to conduct this study? This study is an interventional clinical study. The intervention in the trial is anti-Trop2 U-CAR-NK cells. The administration time is 5 days after chemotherapy. Patients were then evaluated efficacy and safety until 3 years after U-CAR-NK cells infusion. What are the possible benefits and risks of participating? Benefits: The effect of anti-tumor of NK cells may be used to disease control. Risks: Subjects may have adverse reactions to the treatment. These adverse reactions may include abnormal liver injury, fever, and possibly other unknown adverse reactions. Where is the study run? Henan Cancer Hospital.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
chemotherapy followed by Trop2 CAR-NK infusion
Safety by Common Terminology Criteria for Adverse Events (CTCAE) V5.0
The type, frequency, severity, and duration of adverse events as a result of Trop2 CAR-NK cells infusion will be summarized.
Time frame: Up to 1 year
Objective Response Rate (ORR)
Per Response Evaluation Criteria in Solid Tumours (RECIST 1.1) assessed by MRI or CT. ORR defined as the proportion of patients in whom a complete response (CR) or partial response (PR) is observed as best overall response, prior to progression or further anti-cancer therapy.
Time frame: up to 1 year.
Disease control rate (DCR)
Disease control rate (DCR) defined as the proportion of patients in whom a CR or PR or stable disease (SD) (per RECIST 1.1, SD assessed at least 6 weeks after the first dose) is observed as best overall response.
Time frame: up to 1 year.
Overall survival (OS)
To determine the anti-tumor effectivity
Time frame: up to 3 years.
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