NK Cell-based Immunotherapy as Maintenance Therapy for Small-Cell Lung Cancer.

About this trial

Last updated 8 years ago

Study ID

FHJLU-001

Status

Unknown

Type

Interventional

Phase

Phase 2

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Ended 6 years ago

What is this trial about?

Natural killer (NK) cells can kill a broad array of tumor cells in a non-major histocompatibility complex(MHC)-restricted manner. Adoptive transfer of NK may prolong the survival of patients with cancer. This study evaluates the efficacy and safety of NK cell-based immunotherapy for small-cell lung cancer (SCLC) after first-line chemotherapy. Half of the participants will receive autologous adoptive transfer of NK cells after the response from first-line chemotherapy, while the other half will be followed up in routine clinal practice.

What are the participation requirements?

Inclusion Criteria

* Histologically or cytologically confirmed small cell lung cancer.

* Having completed first-line therapy in the presence of stable disease (SD), partial remission (PR) or complete remission (CR) status.

* Age ≥18 years.

* Karnofsky Performance Status (KPS) ≥80.

* Important organs:cardiac ejection fraction >50%; Pulse Oxygen Saturation(SpO2) >90%; creatinine (Cr) ≤ 2.5 times the normal range; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times the normal range, total bilirubin (TBIL)≤2.0mg/dl (34.2umol/L);Hgb≥60g/L.

* Without contraindication of apheresis and cell isolation.

* Patients and their families having the willingness to participate in clinical trial with signed written informed consent.

Exclusion Criteria

* Patient having an active rheumatic immunologic disease.

* Uncontrolled bacterial, fungal or viral infection.

* human immunodeficiency virus(HIV), hepatitis B virus infection(HBV), hepatitis C virus(HCV) infection.

* History of organ transplantation and hemopoietic stem cell transplantation.

* Pregnant or lactating women.

* Patients using immunosuppressive agents within the first 3 months of the study or received glucocorticoid systemic therapy within a week prior to entry into the study.

* Patients receiving other immunotherapy after diagnosis.