This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D-based CAR-T cells infusion in the treatment of advanced NKG2DL+ solid tumors.
Patients diagnosed as advanced solid tumors histopathologically or cytologically, such as ovarian, cholangiocarcinoma, and colorectal cancer.
Patients fail standard treatment , or cannot tolerate standard treatment, or there is no standard treatment, the standard treatment recommendations refer to the latest version of the guidelines of the national comprehensive cancer network (NCCN) or the guidelines of the Chinese society of Clinical Oncology (CSCO);
Age 18-70 years;
ECOG score 0-1;
Patients had received any gene therapy (including CAR-T cell therapy) or any T cell therapy, Active bacteria or viral or fungal infection and not controlled after anti-infective treatment (positive blood test 72 hours before infusion), Syphilis, Human immunodeficiency virus (HIV), Active hepatitis B (HBV DNA≥500IU/ml) or hepatitis c (anti-HCV positive and HCV RNA higher than the detection limit of analysis method);
Patients have an autoimmune disease or organ transplant, require chronic systemic steroid therapy or any other form of immunosuppressive drugs;
A history of serious heart or lung disease, including uncontrolled hypertension medication, and any condition that occurred within the past 6 months: congestive heart failure (New York Heart Association functional classification ≥3), cardiac angioplasty and stents, myocardial infarction, unstable angina, or other clinically severe heart disease;
Detected clinically relevant central nervous system (CNS) metastases and/or pathologies, such as seizures, cerebral ischemia/bleeding, dementia, cerebellar diseases or autoimmune diseases affecting the CNS;
Single group
KD-025 cell injection
DrugThis is an open-label, dose escalation/expansion study to assess the safety, tolerability, and efficacy of KD-025 cell infusion in patients with advanced NKG2DL+ solid tumor. In this study,the enrollment of the patients must meet the inclusion and exclusion criteria . All subjects will be undergo screening, pre-treatment (cell product preparation;lymphodepleting chemotherapy), treatment and follow up
treatment-emergent adverse events(TEAEs)
An adverse event is any undesirable experience associated with the use of a medical product in a patient
Dose-limiting toxicity (DLT) rate
A drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.
CAR positive T cells in patients
The time of CAR-T cell reach the peak and turn back to baseline
Objective response rate(ORR)
objective tumor response rate will be calculated for patients with measurable disease per RECIST 1.1 only
Progression free survival(PFS)
the time from the date of first infusion of the KD-025 to the first documented disease progression (according to RECIST 1.1) or death (due to any cause), whichever occurs first
Overall survival #OS#
the time from the date of first infusion of KD-025 to death of the subject
Complete remission (CR)
the time from the date of first infusion of KD-025 to death of the subject
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