SCLC, Extensive StagePhase 1NEUK203-13NCT07366658

Safety, Tolerability and Preliminary Efficacy of NEUK203-13 in Refractory Neuroendocrine Tumor Patients

A Phase 1 study testing Biological/Vaccine: NK Cell Therapy Product Derived from Induced Pluripotent Stem Cells (iPSCs) Engineered with Anti-DLL3 CAR Construct, Followed by Differentiation and Expansion in people with SCLC, Extensive Stage and Neuroendocrine Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This is a Phase I clinical trial being conducted in humans for the first time, aiming to evaluate a novel cell therapy called NEUK203-13 Injection for the treatment of patients with advanced small cell lung cancer (SCLC) who have failed systematic therapy or late stage neuroendocrine tumors(NETs). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: SCLC, Extensive Stage, Neuroendocrine Tumors
What is being tested?: Biological/Vaccine: NK Cell Therapy Product Derived from Induced Pluripotent Stem Cells (iPSCs) Engineered with Anti-DLL3 CAR Construct, Followed by Differentiation and Expansion
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteChina
Study dates: 20 Feb 2026to 20 Jan 2027
Phase: 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

1. Understand and voluntarily sign the Informed Consent Form (ICF);
2. Aged ≥ 18 years and < 75 years at the time of signing the ICF, regardless of gender;
3. Pathologically confirmed neuroendocrine tumors, including small cell lung cancer (SCLC), etc.;
4. Previous failure or intolerance to systemic therapy, or recurrence after remission: among them, patients with small cell lung cancer must have received at least platinum-based chemotherapy with or without PD-1/PD-L1 inhibitors in previous treatments, with imaging evidence of disease progression after treatment;
5. Must provide tissue samples for biomarker analysis, preferably newly obtained tissues. For patients unable to provide newly obtained tissues, 4 unstained sections of archived formalin-fixed, paraffin-embedded (FFPE) tissues can be provided (at least 1 patient with high DLL3 expression shall be enrolled in each dose group: high expression is defined as positive staining in ≥ 50% of tumor cells; preference is given to enrolling DLL3-positive patients);
6. Have at least one measurable lesion as the target lesion (per RECIST v1.1 criteria);

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7. Expected survival ≥ 3 months;
8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
9. Have adequate bone marrow reserve and organ function within 7 days before the first administration of NEUK203-13 Injection:
10. Sufficient bone marrow function (no supportive therapy within 14 days before the first administration): hemoglobin (Hb) ≥ 90 g/L, platelets (PLT) ≥ 75 × 10⁹/L, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L;
11. Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), total bilirubin (TBIL) < 1.5 × ULN;
12. Renal function: serum creatinine (Scr) ≤ 1.5 × ULN and creatinine clearance rate (Ccr) ≥ 60 mL/min (calculated according to the Cockcroft-Gault formula); Coagulation function: prothrombin time (PT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 2.0;
13. Female patients of childbearing potential or male patients whose partners are of childbearing potential agree to use highly effective contraceptive measures from any dose administration in the study until 6 months after the last dose of the study.

Who cannot join

1. Mixed carcinoma with non-neuroendocrine tumor components;
2. Active brain metastases (patients with stable disease for 3 months after treatment without the need for continued glucocorticoid therapy are eligible for enrollment); known leptomeningeal metastases; isolated central nervous system (CNS) disease progression without evidence of progression outside the CNS;
3. A history of hypersensitivity to interleukin-2 (IL-2), fludarabine, cyclophosphamide, tocilizumab, or any component of the infusion product formulation; or patients with a history of specific allergic disorders (asthma, rubella, eczematous dermatitis);
4. Prior receipt of any of the following treatments:
5. Any systemic antineoplastic therapy within 4 weeks or 5 half-lives prior to the first administration of NEUK203-13 Injection, whichever is shorter;
6. Radiotherapy not involving the thoracic cavity within 2 weeks prior to the first administration of NEUK203-13 Injection, or radiotherapy involving the thoracic cavity within 4 weeks prior to the first administration of the study drug, whichever is longer;

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7. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study;
8. Prior vaccination with an antineoplastic vaccine, or receipt of a live vaccine within 4 weeks prior to the first administration of NEUK203-13 Injection;
9. Major surgery or severe trauma within 4 weeks prior to the first administration of NEUK203-13 Injection;
10. Failure of toxicities from prior antineoplastic therapy to resolve to ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) (except alopecia) or to the level specified in the inclusion/exclusion criteria, whichever is more stringent;
11. Active autoimmune disease or a history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); exceptions include patients with vitiligo, patients with a history of childhood asthma/allergies that have resolved completely and require no intervention in adulthood, patients with autoimmune-mediated hypothyroidism receiving a stable dose of thyroid replacement hormone, and patients with type 1 diabetes receiving a stable dose of insulin;
12. A history of immunodeficiency, including positive HIV test results, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;
13. Severe infection (CTCAE > Grade 2) within 4 weeks prior to the first administration of NEUK203-13 Injection, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging indicating active pulmonary inflammation; or presence of signs and symptoms of infection requiring oral or intravenous antibiotic therapy within 2 weeks prior to the first administration of the study drug (except for prophylactic antibiotic use);
14. Tuberculosis infection identified by medical history or CT examination; Active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (positive anti-HCV antibodies and HCV-RNA above the lower limit of detection of the assay), or positive syphilis test results (including positive RPR or TPPA);
15. Prior diagnosis of any other malignant tumor, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or breast cancer, or adequately treated localized prostate cancer;
16. Pregnant or lactating women;
17. Uncontrolled concurrent diseases, including but not limited to: documented cerebrovascular events (stroke or transient ischemic attack) within 6 months prior to the first administration of the study drug, symptomatic congestive heart failure, left ventricular ejection fraction (LVEF) < 50%, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmias, severe chronic gastrointestinal disease with diarrhea, or severe dyspnea requiring oxygen therapy;
18. A definite history of neurological or psychiatric disorders that, in the investigator's judgment, may affect the patient's cognitive function or compliance, including unstable epilepsy, dementia, schizophrenia, etc.; or psychiatric illnesses/social conditions that may affect study compliance, significantly increase the risk of adverse events, or impair the patient's ability to provide written informed consent;
19. Other factors judged by the investigator that may force the patient to terminate the study prematurely, such as severely abnormal laboratory test results, and/or family or social factors that may affect patient safety or the collection of trial data.

Trial locations and contacts

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

Ning Li, MD contact

86-010-87788713

lining@cicams.ac.cn

Shuhang Wang, PhD contact

13581809307

wangshuhang@cicams.ac.cn

China1 site, 1 recruiting

Cancer Hospital of CICAMS
Beijing
Jiawei Zhou, 86-010-87788713, zhoujw@cicams.ac.cn
Ning Li, MD
Recruiting

Other trials in China

About this study

Official title: A Study to Explore the Safety, Tolerability, and Preliminary Efficacy of NEUK203-13 Injection in Patients With Neuroendocrine Tumors Who Have Failed Systemic Therapy

NEUK203-13 Injection is an "off-the-shelf" CAR-NK cell therapy developed based on induced pluripotent stem cell (iPSC) technology, targeting the DLL3 protein highly expressed in SCLC or other neuroendocrine tumors(NETs) .

Primary Objective Primary Endpoint aims to evaluate safety and tolerability Secondary Endpoints aim to preliminarily observe efficacy and investigate the pharmacokinetics of the drug in the body.

Two pre-set dose levels are planned, with an enrollment of 7-9 patients. Treatment Regimen

Lymphodepletion Conditioning: Chemotherapy (Cyclophosphamide + Fludarabine) before cell infusion to clear lymphocytes in the body.
Cell Infusion: NEUK203-13 is administered via intravenous infusion, d1，d4 and d7 for three doses.
Supportive Medication: Concurrent use of IL-2 (Interleukin-2) d1, d4, d7 and d10 to support NK cell persistence.

Target Patient Population Patients with advanced SCLC who have progressed after prior platinum-based chemotherapy or late stage neuroendocrine tumors(NETs) and have a relatively good performance status.

Key Monitoring Focus Close monitoring of risks specific to cell therapy, such as Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).

In short, this study represents the first clinical exploration of NEUK203-13 Injection in patients with advanced small cell lung cancer or other neuroendocrine tumors(NETs). Its primary focus is on safety, while simultaneously gathering preliminary signals on whether the therapy can control tumors, thereby laying the foundation for subsequent clinical development.

Read the detailed description

NEUK203-13 Injection is a chimeric antigen receptor (CAR)-natural killer (NK) cell therapy (CAR-NK) derived from induced pluripotent stem cells (iPSCs). Through site-specific gene editing, it expresses a CAR structure targeting Delta-like Protein 3 (DLL3). Specifically, the CAR construct is introduced into NK cells via transgenic engineering, enabling precise recognition and elimination of malignant/cancer cells expressing the specific antigen DLL3. Beyond CAR molecular transgenesis, an IL-15RF fusion gene is inserted at the CD38 locus to enhance the pharmacokinetic (PK) properties of CAR-iNK cells. Additionally, the immune checkpoint receptor TIM3 is knocked out to improve resistance to the immunosuppressive tumor microenvironment, and a variant CD16 (vCD16, a cleavage-resistant CD16) is inserted to augment antibody-dependent cellular cytotoxicity (ADCC) when used in combination with therapeutic antibodies.

Using clinical-scale production batches and processes, in vitro pharmacodynamic studies and evaluations of NEUK203-13 Injection were conducted across multiple dimensions, including:

Nonspecific cytotoxicity against target cells (human chronic myelogenous leukemia cell line K562) at different process stages and in fresh bulk cells;
Specific cytotoxicity against tumor cells (small cell lung cancer cell lines SHP-77 and H82 with high DLL3 expression, and the human B-lymphoblastic leukemia cell line NALM6-DLL3 with stable exogenous DLL3 expression as target cells);
Cell viability post cryopreservation and thawing;
Cytotoxic activity (both nonspecific and specific) post cryopreservation and thawing.

NEUK203-13 represents an iterative upgrade of the first-generation product NEUK200-13. The accelerated advancement of NEUK203-13 into clinical research is based on the established clinical safety data of NEUK200-13 and the superior preclinical data of NEUK203-13.

Conditions: SCLC, Extensive Stage, Neuroendocrine Tumors
Being tested: Biological/Vaccine: NK Cell Therapy Product Derived from Induced Pluripotent Stem Cells (iPSCs) Engineered with Anti-DLL3 CAR Construct, Followed by Differentiation and Expansion
Keywords: Car-NK cells, iPSC
Medical subject headings: Neuroendocrine Tumors

What participants receive

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

Biological/Vaccine: NK Cell Therapy Product Derived from Induced Pluripotent Stem Cells (iPSCs) Engineered with Anti-DLL3 CAR Construct, Followed by Differentiation and ExpansionBiological
Intravenous infusion of NEUKIO203-13 d1,d4,d7 and IL-2 6 mIU d1,d4,d7 and d10 was administered following lymphodepletion with cyclophosphamide combined with fludarabine.

Study groups in NCT07366658
Study group	Role	What they receive
Intravenous infusion of NEUKIO203-13 was administered following lymphodepletion	Experimental	Intravenous infusion of NEUKIO203-13 was administered following lymphodepletion with cyclophosphamide combined with fludarabine. Receives: Biological: Biological/Vaccine: NK Cell Therapy Product Derived from Induced Pluripotent Stem Cells (iPSCs) Engineered with Anti-DLL3 CAR Construct, Followed by Differentiation and Expansion

What is being measured

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

The incidence and severity of Adverse Events (AEs) / Serious Adverse Events (SAEs) / Adverse Events of Special Interest (AESIs).
This endpoint aims to systematically monitor, record, and evaluate the safety profile of the study treatment by assessing the incidence, severity, duration, and causal relationship of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) throughout the study period.
Measured: 12 months

Secondary outcomes (5)

Detect the number of NEUK203-13 cells in peripheral blood and calculate the PK parameters.
Quantification of NEUK203-13 Cells in Peripheral Blood and Pharmacokinetic (PK) Parameter Calculation
Measured: 12 months
Ratio of DLL3 expression in tumor tissues versus response rate
Correlation Analysis Between DLL3 Expression Ratio in Tumor Tissues and Clinical Response Rate
Measured: 12 months
Objective Response Rate (ORR)
The proportion of evaluable patients who achieve a complete response (CR) or partial response (PR) confirmed by two consecutive assessments separated by a minimum 4-week interval. CR is defined as the disappearance of all target and non-target lesions with no new lesions detected; PR refers to a ≥30% reduction in the sum of the longest diameters of target lesions, with no progression of non-target lesions or new lesions. ORR will be calculated as the percentage of patients with CR or PR relative to the total evaluable study cohort.
Measured: 12 months
Duration of Response (DoR)
The time interval from the first documentation of CR or PR (per the above criteria) to the first confirmed occurrence of disease progression (per RECIST v1.1) or death from any cause, whichever occurs first. For patients who maintain a response until the end of the study, DoR will be censored at the date of the last tumor assessment.
Measured: 12 months
Disease Control Rate (DCR)
The percentage of evaluable patients whose disease is controlled, encompassing those with CR, PR, and stable disease (SD). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, with the sum of target lesion diameters changing by <30% (increase) and <20% (decrease) from baseline. DCR will be calculated as the proportion of patients with CR, PR, or SD relative to the total evaluable cohort, with SD required to last for a minimum of the predefined assessment cycle to be included.
Measured: 12 months

Timeline

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

20 Feb 202620 Jan 2027

First posted26 Jan 2026
Study start20 Feb 2026
Primary completion20 Oct 2026 (estimated)
Study completion20 Jan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SCLC, Extensive StageStudies of the same condition, open and under way.
More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Model description: Two dose groups are preset. For the first subject in the initial dose group, NEUK203-13 Injection is administered intravenously at a dose of 2×10⁹ cells, once every 3 days (Q3D) for a total of 3 consecutive doses. The Safety Monitoring Committee (SMC) may decide to proceed to the second dose group based on the available safety/tolerability data and pharmacokinetic/biomarker data. For subjects in the second dose group, NEUK203-13 Injection is administered intravenously at a dose of 4×10⁹ cells, once every 3 days (Q3D) for a total of 3 consecutive doses.
Masking: None (open label)
Enrolment: 9 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07366658
Sponsor's protocol ID: NEUK203-13-IIT-01
Acronym: NEUK203-13
Status last verified: Jan 2026
First submitted: 4 Jan 2026
Last updated: 25 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Ning Li, MD

86-010-87788713

lining@cicams.ac.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingPhase 3
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
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Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
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Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage

All SCLC, Extensive Stage trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Explore the Safety, Tolerability, and Preliminary Efficacy of NEUK203-13 Injection in Patients With Neuroendocrine Tumors Who Have Failed Systemic Therapy
ClinicalTrials.gov ID: NCT07366658
Acronym / sponsor ID: NEUK203-13 / NEUK203-13-IIT-01
Conditions: SCLC, Extensive Stage, Neuroendocrine Tumors
Keywords: Car-NK cells, iPSC
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 9 participants (estimated)
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
Collaborators: Neukio Biotherapeutics (Shanghai) Co., Ltd.
Study start: 20 Feb 2026 (actual)
Primary completion: 20 Oct 2026 (estimated)
Study completion: 20 Jan 2027 (estimated)
First posted: 26 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary Objective Primary Endpoint aims to evaluate safety and tolerability Secondary Endpoints aim to preliminarily observe efficacy and investigate the pharmacokinetics of the drug in the body.

Two pre-set dose levels are planned, with an enrollment of 7-9 patients. Treatment Regimen

Lymphodepletion Conditioning: Chemotherapy (Cyclophosphamide + Fludarabine) before cell infusion to clear lymphocytes in the body.
Cell Infusion: NEUK203-13 is administered via intravenous infusion, d1，d4 and d7 for three doses.
Supportive Medication: Concurrent use of IL-2 (Interleukin-2) d1, d4, d7 and d10 to support NK cell persistence.

Key Monitoring Focus Close monitoring of risks specific to cell therapy, such as Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).

Detailed description

Using clinical-scale production batches and processes, in vitro pharmacodynamic studies and evaluations of NEUK203-13 Injection were conducted across multiple dimensions, including:

Nonspecific cytotoxicity against target cells (human chronic myelogenous leukemia cell line K562) at different process stages and in fresh bulk cells;
Specific cytotoxicity against tumor cells (small cell lung cancer cell lines SHP-77 and H82 with high DLL3 expression, and the human B-lymphoblastic leukemia cell line NALM6-DLL3 with stable exogenous DLL3 expression as target cells);
Cell viability post cryopreservation and thawing;
Cytotoxic activity (both nonspecific and specific) post cryopreservation and thawing.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: Two dose groups are preset. For the first subject in the initial dose group, NEUK203-13 Injection is administered intravenously at a dose of 2×10⁹ cells, once every 3 days (Q3D) for a total of 3 consecutive doses. The Safety Monitoring Committee (SMC) may decide to proceed to the second dose group based on the available safety/tolerability data and pharmacokinetic/biomarker data. For subjects in the second dose group, NEUK203-13 Injection is administered intravenously at a dose of 4×10⁹ cells, once every 3 days (Q3D) for a total of 3 consecutive doses.

Arm	Type	Receives
Intravenous infusion of NEUKIO203-13 was administered following lymphodepletion	Experimental	Biological: Biological/Vaccine: NK Cell Therapy Product Derived from Induced Pluripotent Stem Cells (iPSCs) Engineered with Anti-DLL3 CAR Construct, Followed by Differentiation and ExpansionIntravenous infusion of NEUKIO203-13 was administered following lymphodepletion with cyclophosphamide combined with fludarabine.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

1. Understand and voluntarily sign the Informed Consent Form (ICF);
2. Aged ≥ 18 years and < 75 years at the time of signing the ICF, regardless of gender;
3. Pathologically confirmed neuroendocrine tumors, including small cell lung cancer (SCLC), etc.;
4. Previous failure or intolerance to systemic therapy, or recurrence after remission: among them, patients with small cell lung cancer must have received at least platinum-based chemotherapy with or without PD-1/PD-L1 inhibitors in previous treatments, with imaging evidence of disease progression after treatment;
5. Must provide tissue samples for biomarker analysis, preferably newly obtained tissues. For patients unable to provide newly obtained tissues, 4 unstained sections of archived formalin-fixed, paraffin-embedded (FFPE) tissues can be provided (at least 1 patient with high DLL3 expression shall be enrolled in each dose group: high expression is defined as positive staining in ≥ 50% of tumor cells; preference is given to enrolling DLL3-positive patients);

Key exclusion criteria (19 listed)

1. Mixed carcinoma with non-neuroendocrine tumor components;
2. Active brain metastases (patients with stable disease for 3 months after treatment without the need for continued glucocorticoid therapy are eligible for enrollment); known leptomeningeal metastases; isolated central nervous system (CNS) disease progression without evidence of progression outside the CNS;
3. A history of hypersensitivity to interleukin-2 (IL-2), fludarabine, cyclophosphamide, tocilizumab, or any component of the infusion product formulation; or patients with a history of specific allergic disorders (asthma, rubella, eczematous dermatitis);
4. Prior receipt of any of the following treatments:
5. Any systemic antineoplastic therapy within 4 weeks or 5 half-lives prior to the first administration of NEUK203-13 Injection, whichever is shorter;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Biological/Vaccine: NK Cell Therapy Product Derived from Induced Pluripotent Stem Cells (iPSCs) Engineered with Anti-DLL3 CAR Construct, Followed by Differentiation and ExpansionIntravenous infusion of NEUKIO203-13 d1,d4,d7 and IL-2 6 mIU d1,d4,d7 and d10 was administered following lymphodepletion with cyclophosphamide combined with fludarabine.	Biological	Intravenous infusion of NEUKIO203-13 was administered following lymphodepletion

Primary outcome

The incidence and severity of Adverse Events (AEs) / Serious Adverse Events (SAEs) / Adverse Events of Special Interest (AESIs).
Time frame: 12 months
This endpoint aims to systematically monitor, record, and evaluate the safety profile of the study treatment by assessing the incidence, severity, duration, and causal relationship of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) throughout the study period.

5 secondary outcomes

Detect the number of NEUK203-13 cells in peripheral blood and calculate the PK parameters.
Time frame: 12 months
Ratio of DLL3 expression in tumor tissues versus response rate
Time frame: 12 months
Objective Response Rate (ORR)
Time frame: 12 months
Duration of Response (DoR)
Time frame: 12 months
Disease Control Rate (DCR)
Time frame: 12 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
Individual participant dataSharing planned: No

Related trials for SCLC, Extensive Stage

Active, not recruitingPhase 3
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
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A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
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Not yet recruitingPhase 2
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Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Ning Li, MD contact

86-010-87788713

lining@cicams.ac.cn

Shuhang Wang, PhD contact

13581809307

wangshuhang@cicams.ac.cn

Shuhang Wang, PhD study director

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Ning Li, MD (86-010-87788713, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence and severity of Adverse Events (AEs) / Serious Adverse Events (SAEs) / Adverse Events of Special Interest (AESIs). (time frame: 12 months). 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 NCT07366658.

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 25 Jun 2026.