Clinical trial · Interventional
Zeushield Cytotoxic T Lymphocytes (Z-CTLs) for Relapsed or Refractory Non Small Cell Lung Cancer (NSCLC)
Preliminary Clinical Study of Autologous T Cells Modified Chimeric Antigen Receptor (CAR) Targeting PD-L1 and CD80/CD86 (Zeushield Cytotoxic T Lymphocytes) for the Treatment of Recurrent or Refractory Non Small Cell Lung Cancer
NCT03060343CI-TRIAL-00026087unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A single-center, open-label pilot study to determine the safety, tolerance and engraftment potential of zeushield cytotoxic T lymphocytes in subjects with PD-L1+ positive non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zeushield Cytotoxic T Lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zeushield Cytotoxic T Lymphocytes
- description
- Enrolled patients will receive Zeushield Cytotoxic T Lymphocytes by infusion
- interventionNames
- Biological: Zeushield Cytotoxic T Lymphocytes
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- 8 weeks
- description
- Observe and determine the potential adverse events related to the escalating dose infusion of Z-CTLs such as high fever,jaundice, kidney failure and so on.
Secondary outcomes (5)
- measure
- Number of Z-CTLs in peripheral blood samples after infusion
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men or women aged \>18 years old * Subjects are diagnosed as refractory, recurrent ,metastatic, advanced non-small cell lung cancer by histological and cytological methods including specific lesion-targeted brush biopsy, lavage and fine needle aspiration; * Have at least one new measurable tumor lesion compared with previous irradiated region * Tumor tissues samples confirmed as PD-L1 positive * Expected survival≥12 weeks * ECOG scored as 0-1 or KPS grading \> 80 * PLT≥100000/mm3 * Hb≥9.0g/dL * Serum creatinine≤2.5mg/dL,CCR≥50ml/min (renal malfunction defined as CCR\<50ml/min according to Cockroft-Gault formula) * ALT and AST≤2.5ULN; for liver metastasis,ALT and AST ≤5ULN * Serum TBiL≤3.0mg/dL, TBiL≤2.5ULN * PT: INR \< 1.7 or extended PT to normal value \< 4s * Adequate venous access for apheresis or venous blood collection, and no other contraindication of blood cell separation * Patients with willingness to be in this study and able to provide informed consent * Capable of receiving treatment and follow up, included subjects are required to receive treatment in the enrolled centre * Women of childbearing age are required to take acceptable measures to minimize the possibility of pregnancy during whole session. Women of childbearing age must have negative results of serum or urine tests within 24 hours prior to infusion. Women subjects must not be in lactation; Exclusion Criteria: * pregnant women or women in lactation * active HBV or HCV infection * HIV/AIDS infection * active infection * previously suffered from diseases or concurrent diseases as followed: * patients confirmed as severe autoimmune diseases in long-term (over 2 months) need of systemic immune inhibitors (steroid) or as immune-mediated symptomatic diseases including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis (for example, Wegener's granulomatosis) * subjects with previous diagnosis as motor neurone disease caused by autoimmunity * subjects previously suffered from toxic epidermal necrolysis (TEN) * subjects with any mental diseases including dementia, mental status change that may impinge the understanding and performance of informed consent and related questionnaire * subjects with severe, uncontrollable diseases judged by investigators that may hinder them receiving this treatment * subjects with previously active malignant tumors including basal or squamous skin cancer, superficial bladder cancer, and in situ breast carcinoma within 5 years who had been completely cured without the need of follow-up treatment are not excluded. * during ongoing treatment using systemic steroid or steroid inhalants * subjects with unstable or active peptic ulcer or alimentary tract hemorrhage * subjects with previous organ transplantation or ready for organ transplantation * subjects in need of anticoagulant therapy treatment (warfarin or heparin) * subjects judged by investigators as not appropriate for this study
References
Publications (0)
Data not yet available
No reference posted for this study.