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Small Cell Lung CancerEarly Phase 1iNK-SCLCNCT06747832

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

A Early Phase 1 study testing iNK cells in people with Small Cell Lung Cancer, run by Guangzhou Ruixin Biotechnological Co., LTD at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
iNK cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
15 Dec 2024to 14 Dec 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • 1.1.2 Complete left bundle branch block, second- or third-degree atrioventricular block.
  • 1.1.3 Severe, uncontrolled cardiac arrhythmias requiring medication. 1.1.4 New York Heart Association (NYHA) class II or above congestive heart failure.
  • 1.1.5 Left ventricular ejection fraction (LVEF) < 50% in color Doppler echocardiography.
  • 1.1.6 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.
  • 1.2 Renal: SCR > 1.5 x ULN or calculated creatinine clearance (Cockcroft-Gault Formula) <60 mL/min.
Show all 19Show fewer
  • 1.3 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.
  • 8. 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).
  • 6.8.2 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.
  • 6.8.3 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.
  • Participated in other intervention clinical studies within 4 weeks before screening;
  • People who are allergic to human blood albumin.
  • People who are allergic to IL-2.
  • Patients who are judged by the investigator to be unsuitable for participating in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Weifang People's Hospital

    Weifang, Shandong Province, China., 261000

Other trials in China

About this study

Official title: A Single-center, Single-arm Clinical Study of the Efficacy and Safety of INK Cells As Maintenance Therapy After Chemoradiotherapy for Small Cell Lung Cancer

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

Read the detailed description

Natural killer (NK) cells are lymphocytes of the innate immune system and could recognize and kill a wide range of cells in distress, particularly tumour cells and cells infected with viruses. Induced pluripotent setm cells(iPSCs) derived NK cells have better proliferative capacity and homogeneity than donor peripheral blood or umbilical cord blood derived NK cells. The investigators conduct this clinical study to evaluate the efficacy and safety of INK cells as maintenance therapy after chemoradiotherapy for small cell lung cancer and The purpose of investigators is to find new treatment option.

Being tested
iNK cells
Keywords
iNK Cellular therapy sclc
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iNK cellsDrug

    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.

Study groups in NCT06747832
Study groupRoleWhat they receive
iNK Cell therapy groupExperimentalIntravenous 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.
Receives: Drug: iNK cells

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months

  2. Objective-response rate (ORR)

    Measured: 12 months

Secondary outcomes (3)

  1. Progression Free Survival (PFS)

    Measured: 12 months

  2. Duration of Response (DoR)

    Measured: 12 months

  3. Overall Survival (OS)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2024
  2. Study start15 Dec 2024 (estimated)
  3. Primary completion14 Jun 2026 (estimated)
  4. Study completion14 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A single-center, single-arm clinical study.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06747832
Sponsor's protocol ID
iNK-SCLC
Acronym
iNK-SCLC
Status last verified
Dec 2024
First submitted
8 Dec 2024
Last updated
24 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: What data in particular will be shared? Individual participant data that underlie the results reported in this article, after deidenti- fication (text, tables, figures, and appendices). What other documents will be available？ Study Protocol. When will data be available (start and end dates)? Beginning 9 months and ending 36 months following article publication. With whom? Investigators whose proposed use of the data has been approved by an independent review committee(learned intermediary) identified for this purpose. For what types of analyses? For individual participant data meta-analysis. By what mechanism will data be made available? Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in clinical research center of the fifth affiliated hospital of Guangzhou medical university (https://www.wfph.cn/news/44/).

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing iNK cells in people with Small Cell Lung Cancer, run by Guangzhou Ruixin Biotechnological Co., LTD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Event (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v5.0 (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06747832.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.

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