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

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC (Non-small Cell Lung Cancer)
• Intervention / Treatment: Biological: Whole Agonist-Stimulated T (WAST) cells injection; Drug: Docetaxel

• Study Type: Interventional
• Enrollment (Estimated): 31
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Liang Liu, MD. Ph.D; Phone Number: +86-22-23340123-6417; Email: liuliang@tjmuch.com

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: Liang Liu, MD. Ph.D; Phone Number: +86-22-23340123-6417; Email: liuliang@tjmuch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WAST Cells Plus Docetaxel; Patients will receive WAST cells in combination with docetaxel once every 3 weeks for 4 cycles. Following completion of the combination phase, patients will continue on docetaxel monotherapy until disease progression, unacceptable toxicity, or voluntary withdrawal from the study.	Biological: Whole Agonist-Stimulated T (WAST) cells injection; WAST cells (≥4.0 × 10⁹ cells), intravenous infusion, d14, Q3W for 4 cycles.; Drug: Docetaxel; 75 mg/m², intravenous infusion, day 1, Q3W.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	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.	Time Frame: Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	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.	up to 24 months
Overall Survival (OS)	OS was defined as the time from the initial treatment until the date of death due to any cause.	up to 3 years
Duration of response (DOR)	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.	up to 24 months
Disease Control Rate (DCR)	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.	up to 24 months
Number of Participants Who Experienced an Adverse Event (AE)	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.	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)

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytological Techniques; Cell Physiological Phenomena; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel; Cell Count
• Other Study ID Numbers: E20251324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No