EGFR-positive advanced solid tumor
Conditions
Interventions
Test group:NKD0901 cells
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Sign informed consent form prior to any study related procedure; 2.Aged 18 to 75 years, any gender; 3.Positive EGFR expression with life expectancy > 3 month; 4.Patients with advanced (stage IIIb, IIIc, not suitable for multidisciplinary treatment), metastatic (stage IV), or relapsing egFR-positive solid tumors that are histologically or cytologically confirmed and inoperable, that have systemic failure or intolerance, and/or that currently have no effective standard treatment; 5.The investigator identified at least one measurable and evaluable tumor focus. (Solid tumors were assessed according to RECIST 1.1 criteria and were tentatively assessed using iRECIST criteria; Glioblastoma was determined by iRANO criteria; Lymphoma according to International Working Group standard/revised standard); 6.Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (GLIoblastoma KPS >= 50); 7.In addition to the primary disease, no serious hematological, cardiopulmonary, liver or kidney diseases, Hemoglobin >= 90 g/L, Neutrophil >= 1.5x10^9 /L; Platelet >= 100x10^9 /L; 8.For patients without liver metastasis, Total bilirubin<1.5 x ULNAST and ALT < 2.5 x ULN; For liver metastatic or liver cancer, total bilirubin<3 x ULN, AST and ALT < 5 x ULN; 9.Adverse reactions caused by previous treatment recovered to grade 1 or below before enrollment (except hair loss); 10.Negative blood pregnancy test in women of reproductive age and consent of both men and women to use medically approved effective contraceptive methods throughout the trial period and for 6 months after the trial (see appendix 2 for details); 11.Patients were able to follow up regularly, communicate well with the investigator, and complete the study according to study guidelines.
Exclusion criteria
Exclusion criteria: 1.Have active diverticulitis, intra-abdominal abscess or gastrointestinal obstruction; 2.Have received organ transplantation or blood system transplantation; 3.Have clinically uncontrolled pleural effusion or ascites; 4.In combination with conditions including severe cadiovascular desease, cerebrovascular accident, uncontrolled diabetes mellitus, uncontrolled high blood pressure, active peptic ulceractive bleeding; 5.History of infection of active pulmonary tuberculosis or active pulmonary tuberculosis; 6.Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-AB), acquired immune deficiency syndrome antibody (AntiHIV) and anti-treponema pallidum antibody (TP-AB) are positive and meet any of these requirements. HBsAg positive patients with HBV-DNA<500IU/ mL and HCV-AB positive patients with normal liver function could not be excluded from the inclusion of HCC patients; 7.Participation in another clinical study or reciept of any investigative treatment within 30 days prior to enrolment; 8.An active autoimmune disease requiring systemic therapy (e.g., palliative drugs, corticosteroids, or immunosuppressants) occurred within 2 years prior to initial administration. Alternative therapies (e.g. thyroxine, insulin, or physical corticosteroids for adrenal or pituitary dysfunction) are not considered systemic; 9.Diagnosed as immunodeficient or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to study initial dosing; Physiological doses of glucocorticoids are permitted (<=10 mg/ day of prednisone or equivalent); 10.Not fully recovered from toxicity and/or complications associated with any intervention (i.e., <=1 or at baseline, excluding fatigue or hair loss) before initiation of treatment; 11.Known symptomatic central nervous system metastases. For asymptomatic brain metastasis or stable desease after treatment, patients meet all following criteria is acceptable: measurable lesion out of CNS; no midbrain, pons, cerebellum, medulla oblongata, spin metastasis; stay clinical stable at least 2 weeks; steroid therapy discontinued 3 days prior to study drug administration; 12.A history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year prior to initial administration or current presence of interstitial lung disease; 13.A known mental illness or substance abuse condition that may affect compliance with test requirements; 14.Received live vaccine within 30 days prior to initial administration (cycle 1, day 1); Note: Administration of injectable inactivated virus vaccine against seasonal influenza is permitted within 30 days prior to first administration, but intranasally administered live attenuated influenza vaccine is not permitted; 15.Any medical history or evidence of disease that may interfere with the results of the study, interfere with the subjects' full participation in the study, have abnormal values in treatment or laboratory tests, or other conditions that the investigator considers inappropriate for enrollment; 16.Breastfeeding women; 17.Patients with insufficient communication, understanding and cooperation (except for patients with glioblastoma), or poor compliance to ensure compliance with protocol requirements; 18.The investigator considered that the candidate was not suitable to participate in the clinical trial for various reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survial;Overall Survival; | — |
Countries
China
Contacts
Public ContactYe Feng
The First Affiliated Hospital of Xiamen University
Outcome results
None listed