RecruitingPhase 2NCT07330050

WAST Cell-Docetaxel Combination Therapy in PD-1 Inhibitor-Resistant Advanced NSCLC

Phase II Clinical Trial Evaluating Whole Agonist-Stimulated T (WAST) Cells in Combination With Docetaxel as a Second-line Treatment for Advanced Non-small Cell Lung Cancer (NSCLC) Resistant to PD-1 Inhibitors

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

31 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

NSCLC (Non-small Cell Lung Cancer)

Summary

This prospective Phase II study aims to evaluate the preliminary efficacy and safety of WAST cells combined with docetaxel as second-line therapy in patients with advanced NSCLC resistant to PD-1 inhibitors.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

At screening, patients must meet the following diagnostic and treatment criteria: 1) Histologically or cytologically confirmed NSCLC, 2) Advanced NSCLC as determined by imaging according to AJCC V8, 3) Disease progression after first-line treatment with a PD-1 inhibitor; Expected survival time greater than 3 months;
At screening, measurable target lesions on imaging with the longest diameter greater than 1.0 cm;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening;
Adequate bone marrow reserve at screening, defined as:
Absolute neutrophil count (ANC) \>1.5×10⁹/L; Absolute lymphocyte count (ALC) ≥0.3×10⁹/L; Platelets (PLT) ≥100×10⁹/L; Hemoglobin (HGB) ≥100g/L;
Adequate organ function at screening, meeting the following criteria:
Aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN) (≤5 ULN if due to tumor infiltration); Alanine aminotransferase (ALT) ≤2.5 times ULN (≤5 ULN if due to tumor infiltration); Total serum bilirubin ≤1.5 times ULN (≤3 ULN if due to tumor infiltration); Serum creatinine (Scr) ≤1.5 times ULN, or creatinine clearance rate ≥60 mL/min; Minimum lung reserve level, defined as ≤Grade 1 dyspnea and oxygen saturation \>91% without supplemental oxygen; International Normalized Ratio (INR) ≤1.5 times ULN, and activated partial thromboplastin time (APTT) ≤1.5 times ULN;
Women of childbearing potential must have a negative urine pregnancy test, and any male or female patient capable of having children must agree to use effective contraception throughout the study and for at least 1 year after the last dose of study treatment.

Exclusion Criteria21

Patients with symptomatic central nervous system (CNS) metastases at screening (patients with asymptomatic CNS metastases, or those who have been treated locally and are stable without symptoms for 4 weeks, are eligible);
History of CNS disorders prior to screening, such as epilepsy, cerebrovascular ischemia/hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar diseases, organic brain syndromes, psychiatric disorders, or any autoimmune diseases affecting the CNS;
Received immunotherapy, targeted therapy, chemotherapy, or radiotherapy within 4 weeks before screening, and deemed unsuitable for enrollment by the investigator;
Discontinued systemic corticosteroid therapy less than 72 hours before cell infusion; however, physiological replacement doses of steroids (e.g., prednisone \<10 mg/day or equivalent) are allowed;
Any history of adoptive cell therapy prior to screening;
History of organ/tissue transplantation prior to screening;
Known active systemic autoimmune diseases under treatment prior to screening;
At screening, meets any of the following criteria:
Hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) positive; Hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive, with HBV-DNA copy numbers above the lower limit of quantification; Hepatitis C antibody (HCV-Ab) positive; Treponema pallidum antibody (TP-Ab) positive; HIV antibody test positive; EBV-DNA, CMV-DNA copy numbers above the lower limit of quantification;
Undergone major surgery within 4 weeks prior to screening and deemed unsuitable for enrollment by the investigator;
History of other malignancies within the past 2 years (except successfully treated non-melanoma skin cancer or in situ carcinoma);
At screening, meets any of the following cardiac conditions:
Left ventricular ejection fraction (LVEF) ≤50% (by ECHO); New York Heart Association (NYHA) class III or IV congestive heart failure; Uncontrolled hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg) or pulmonary hypertension despite standard treatment; Myocardial infarction or cardiac surgery within 12 months prior to cell infusion; Clinically significant valvular heart disease;
Tumor involvement of the atrium or ventricle at screening;
History of pulmonary interstitial fibrosis or severe chronic obstructive pulmonary disease (COPD);
Presence of clinical emergencies requiring urgent intervention due to tumor obstruction or compression (e.g., bowel obstruction or vascular compression) at screening;
Active bleeding at screening;
History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening;
Vaccinated with live vaccines within 6 weeks prior to screening;
Active infection requiring treatment at screening;
Participation in another interventional clinical study within 4 weeks prior to screening;