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

NCT ID: NCT03410368

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2020-07-01

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.

Detailed Description

The small-cell lung cancer (SCLC) is very sensitive to the standard-of-care first-line chemotherapy and/or radiotherapy, but it will ultimately progress or relapse and develop early resistance to conventional treatments. No effective maintenance therapy except for wath and wait after first-line therapy at present.

NK cells constitute the major component of the innate immune system and kill tumor cells in a non-MHC-restricted manner. In our previous pilot study and other reports, adoptive transfer of autologous NK cells expanded ex vivo was very well tolerant and effective.

There is no prospective trial on the maintenance therapy of SCLC after first-line chemotherapy based on autologous NK cells. The purpose of this phase II clinical research is to evaluate the efficacy and safety of autologous NK cells as the maintenance therapy after the first-line treatment, comparing with conventional observation group.

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

autologous natural killer cells

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.

Group Type: EXPERIMENTAL

NK cells

Intervention Type: 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.

routine follow-up

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NK cells

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

jiuwei cui

OTHER

Sponsor Role: lead

Responsible Party

jiuwei cui

chief

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

jiuwei cui, PhD

Role: PRINCIPAL_INVESTIGATOR

the Cancer Center of First Hospital of Jilin University

Locations

the First Hospital of Jilin University

Ch’ang-ch’un, Jilin, China

Site Status: RECRUITING

Countries

China

Central Contacts

lei qian, MD

Role: CONTACT

qianlei_cool@126.com

13086891158

Facility Contacts

xuan j li, master

Role: primary

1776514587@qq.com

18844194678

lei qian, master

Role: backup

qianlei_cool@126.com

15843139762

Other Identifiers

FHJLU-001

Identifier Type: -

Identifier Source: org_study_id