INK Cells As Maintenance Therapy After Chemoradiotherapy for Small Cell Lung Cancer

NCT06747832 | Enrolling By Invitation Early Phase 1

• 1 other identifier: iNK-SCLC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical study on the use of iNK cells for the treatment of small cell lung cancer.

Conditions

Small Cell Lung Cancer

Keywords

iNK Cellular therapy sclc

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Event (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v5.0

  12 months

• Objective-response rate (ORR)

  12 months

Secondary Outcomes (3)

• Progression Free Survival (PFS)

  12 months

• Duration of Response (DoR)

  12 months

• Overall Survival (OS)

  12 months

Study Arms (1)

iNK Cell therapy group

EXPERIMENTAL

Intravenous infusion of iNK cells is given to the subject, 5\*108 to 1\*109 cells/dose, three doses per week, a total of 6 doses. And then 1\*109 cells/dose, one doses every 4 weeks , a total of 5 doses.

Drug: iNK cells

Interventions

iNK cells DRUG

Intravenous infusion of iNK cells is given to the subject, 5\*108 to 1\*109 cells/dose, three doses per week, a total of 6 doses. And then 1\*109 cells/dose, one doses every 4 weeks , a total of 5 doses.

iNK Cell therapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to provide informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• Age ≥18 years old and ≤ 75 years old at the time of signing the ICF
• Have cytologically or histologically confirmed diagnosis for the patients with locally advanced unresectable or metastatic small cell lung cancer.
• Have measurable disease as assessed by the investigator according to RECIST 1.1.
• Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
• Have a life expectancy of ≥ 3 months.
• Female participants: Women of childbearing potential (WOCBP) must use a highly effective form of contraception from the screening visit until at least 12 months after the final dose of iNK cells.
• Male participants: Males must be sterile (biologically or surgically) or use a highly effective method of contraception from the screening visit until at least12 months after the final dose of iNK cells.

You may not qualify if:

• Has evidence of insufficient organ function. 1.1 Has active or clinically significant cardiac disease including: 1.1.1 Severe heart rhythm or conduction abnormalities, corrected QT interval (QTc) ≥ 480 ms.
• Complete left bundle branch block, second- or third-degree atrioventricular block.
• Severe, uncontrolled cardiac arrhythmias requiring medication. 1.1.4 New York Heart Association (NYHA) class II or above congestive heart failure.
• Left ventricular ejection fraction (LVEF) \< 50% in color Doppler echocardiography.
• History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, severe pericardial disease, ECG evidence of acute ischemic or active conduction system abnormalities within 6 months prior to recruitment.
• Renal: SCR \> 1.5 x ULN or calculated creatinine clearance (Cockcroft-Gault Formula) \<60 mL/min.
• Liver: 1.3.1 total bilirubin \> 1.5 x ULN. 1.3.2 AST\>2x ULN or ALT\>2x ULN. AST/ALT can be as high as 5× ULN in liver metastases, but it cannot be accompanied by elevated bilirubin 1.4 lung:
• \> grade 1 dyspnea and oxygen saturation ≤ 91% in non oxygen breathing state. 1.5 Hematological: 1.5.1 Absolute neutrophil count (ANC) \< 1.5 x 109/L. 1.5.2 Platelet count\< 100 x 109/L. 1.5.3 Hemoglobin \< 9.0g/dL. 1.5.4 International normalized ratio (INR) \> 1.5 times ULN, and activated partial prothrombin time (APTT) \> 1.5 times ULN;
• At the time of screening, patients with symptomatic central nervous system (CNS) metastases (asymptomatic CNS metastases, or asymptomatic after local treatment and stable condition for 4 weeks can be enrolled).
• Those with a history of central nervous system before screening, such as epilepsy, cerebral ischemia / hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, cerebral organic syndrome, mental disease or any autoimmune disease involving the central nervous system.
• Those who stopped systemic hormone therapy for less than 72 hours before cell transfusion; But it is allowed to use a physiological substitute amount of hormone (such as prednisone \< 10mg / D or equivalent).
• Active systemic autoimmune disease is known before screening and is under treatment.
• \. Those who meet any of the following conditions during screening: 6.8.1 Positive for hepatitis B surface antigen (HBsAg) and / or hepatitis B e antigen (HBeAg).
• Hepatitis B e antibody (HBE AB) and / or hepatitis B core antibody (HBC AB) are positive, and the copy number of HBV-DNA is greater than the lower measurable limit.
• Positive for hepatitis C antibody (HCV AB). 6.8.4 Positive anti Treponema pallidum antibody (TP AB). 6.8.5 HIV antibody test positive. 6.8.6 The copy number of EBV-DNA and cmv-dna is greater than the lower measurable limit.

Sponsors & Collaborators

• Guangzhou Ruixin Biotechnological Co., LTD: lead
• Weifang People's Hospital: collaborator

Study Sites (1)

Weifang People's Hospital

Weifang, Shandong Province, China., 261000, China

Location

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

• Yu Guohua Guohua Yu, Director of the Cancer Dpartment

  Weifang People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single-center, single-arm clinical study.

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 24, 2024
• Study Start: December 15, 2024
• Primary Completion (Estimated): June 14, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee(learned intermediary) identified for this purpose.

Locations

CN (1)