NSCLC (Non-small Cell Lung Cancer)
Conditions
Brief 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.
Interventions
BIOLOGICALWhole Agonist-Stimulated T (WAST) cells injection
WAST cells (≥4.0 × 10⁹ cells), intravenous infusion, d14, Q3W for 4 cycles.
DRUGDocetaxel
75 mg/m², intravenous infusion, day 1, Q3W.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Time Frame: Up to 24 months | ORR was defined as the percentage of patients with a confirmed complete (CR) or partial response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | up to 24 months | PFS was defined as the time from the initial treatment to the first occurrence of disease progression or all-cause death (whichever occurs first) assessed by the investigator according to RECIST v1.1. |
| Overall Survival (OS) | up to 3 years | OS was defined as the time from the initial treatment until the date of death due to any cause. |
| Disease Control Rate (DCR) | up to 24 months | DCR was defined as the proportion of patients with the best overall response of CR, PR, and stable disease (SD) as determined by the investigator according to RECIST 1.1. |
| Duration of response (DOR) | up to 24 months | DOR was defined as first documented evidence of a CR or PR until PD or death as determined by the investigator according to RECIST v1.1. |
| Number of Participants Who Experienced an Adverse Event (AE) | up to 24 months (Serious AEs: Up to 90 days after last dose of study treatment (Other AEs: Up to 30 days after last dose of study treatment) | An AE was defined as any untoward medical occurrence in a study participant administered with study drug and which does not necessarily have to have a causal relationship with this study drug. The number of participants who experienced an AE is presented. |
Countries
China
Contacts
Primary ContactLiang Liu, MD. Ph.D
Outcome results
None listed