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NEUK203-13NEUK203-13 Injection Safety, Tolerability, and Efficacy in Patients with 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

Biological

Who is being recruted

Neoplasms+3

+ Neoplasms by Histologic Type

+ Neoplasms, Germ Cell and Embryonal

From 18 to 75 Years

+31 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: February 2026

See protocol details

Summary

Principal SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

Study ContactNing Li, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 20, 2026

Actual date on which the first participant was enrolled.

This study explores the safety and effectiveness of NEUK203-13 Injection in patients with Neuroendocrine Tumors who have not responded to standard systemic therapy. NEUK203-13 Injection is a type of cell therapy that targets a specific protein, Delta-like Protein 3 (DLL3), found on cancer cells. It is designed to recognize and eliminate these cells. The study is important as it aims to provide a new treatment option for patients who have not benefited from existing therapies, potentially improving their care and addressing unmet needs in the treatment of Neuroendocrine Tumors. During the study, participants will receive the NEUK203-13 Injection. The study measures the results by monitoring and recording any side effects or adverse events. The primary goal is to evaluate the safety of the treatment. This includes assessing the severity, duration, and relationship of any adverse events to the treatment. The study also aims to get a preliminary understanding of how well the treatment works in these patients.

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

NCT07366658

Principal SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

Study ContactNing Li, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

9 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNeuroectodermal TumorsNeuroendocrine Tumors

Criteria

13 inclusion criteria required to participate

Aged ≥ 18 years and < 75 years at the time of signing the ICF, regardless of gender

Pathologically confirmed neuroendocrine tumors, including small cell lung cancer (SCLC), etc.

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

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)

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18 exclusion criteria prevent from participating

Mixed carcinoma with non-neuroendocrine tumor components

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

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)

Any systemic antineoplastic therapy within 4 weeks or 5 half-lives prior to the first administration of NEUK203-13 Injection, whichever is shorter

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Intravenous infusion of NEUKIO203-13 was administered following lymphodepletion with cyclophosphamide combined with fludarabine.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Cancer Hospital of CICAMS

Beijing, ChinaOpen Cancer Hospital of CICAMS in Google Maps

Recruiting soonOne Study Center