WAST cell plus docetaxel for PD‑1–resistant advanced non‑small cell lung cancer

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 will test whether infusions of WAST immune cells combined with docetaxel chemotherapy can shrink tumors or slow progression in people with advanced NSCLC that stopped responding to PD‑1 inhibitors.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT07330050 on ClinicalTrials.gov

What this trial studies

This is a prospective Phase II, single-center trial testing combined WAST cell infusions and docetaxel as a second-line treatment for advanced NSCLC after progression on PD‑1 inhibitors. Eligible patients must have measurable disease, ECOG performance status 0–1, and adequate blood and organ function. The study will look at preliminary anti-tumor activity and safety of the combination regimen. Treatments and follow-up visits are conducted at Tianjin Medical University Cancer Institute and Hospital.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed advanced NSCLC who progressed after first-line PD‑1 inhibitor therapy, have measurable lesions (>1.0 cm), ECOG 0–1, and adequate bone marrow and organ function.

Not a fit: Patients with ECOG performance status >1, inadequate blood counts or organ function, life expectancy ≤3 months, or no measurable target lesions are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could provide a new second-line option that shrinks tumors or prolongs disease control for patients whose cancers no longer respond to PD‑1 inhibitors.

How similar studies have performed: The WAST cell approach is relatively novel with limited direct clinical data in PD‑1–resistant NSCLC, while other cellular immunotherapies have shown mixed results in solid tumors.

Eligibility criteria

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;

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Liang Liu, MD. Ph.D

Conditions NSCLC