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

NCT03410368 | Unknown Phase 2

• 1 other identifier: FHJLU-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Small Cell Lung Cancer

Keywords

maintenance therapy; immunotherapy; adoptive cell transfer; natural killer cell

Outcome Measures

Primary Outcomes (1)

• Progression-free survival(PFS)

  Progression-free survival is defined as the time from randomization to first observation of progression or date of death (from any cause). Progression will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Patients who do not progress or not die will be censored on the date of their last tumor assessment, i.e. on the last date that we really know that the patient is considered as "progression-free".

  20 months

Secondary Outcomes (2)

• Overall survival(OS)

  20 months

• Evaluate the change of the quality of life for all patients

  20 months

Study Arms (2)

autologous natural killer cells

EXPERIMENTAL

Infusion of 1-2×10\^9 NK cells every 14 days in the absence of progression or unacceptable toxicity until the 6 courses of treatment.

Biological: NK cells

routine follow-up

NO INTERVENTION

According to present guideline, no special treatment is advised for patients with SCLC after first-line therapy.They will be followed-up regularly.

Interventions

NK cells BIOLOGICAL

Autologous peripheral blood mononuclear cells (PBMCs) are collected by apheresis on D0, then induced into NK cells and infused into the patients 14 days later (D14) as the initial transfusion. There are 3 consecutive transfusion days (D14-D16). The second course of PBMCs collection started D14 before infusion. A total of 6 courses will be completed unless progression or unacceptable adverse events.

autologous natural killer cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• jiuwei cui: lead

Study Sites (1)

the First Hospital of Jilin University

Ch’ang-ch’un, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• jiuwei cui, PhD

  the Cancer Center of First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

lei qian, MD

CONTACT

13086891158; qianlei_cool@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief

Model Details: Patients with small-cell lung cancer receive autologous NK cells adoptive cancer immunotherapy as a maintenance therapy in the presence of stable disease (SD), partial remission (PR) or complete remission (CR) after the first-line chemotherapy.

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 25, 2018
• Study Start: April 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2020
• Last Updated: July 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)