NCT07366658: NEUK203-13

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

Not yet recruiting Phase 1 Last updated 26 January 2026

What this trial tests

Phase 1 trial 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 SCLC, Extensive Stage in 9 participants. Not yet recruiting.

Timeline

20 February 2026

Primary endpoint
20 October 2026

20 January 2027

Quick facts

Lead sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase	Phase 1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	20 February 2026
Primary completion	20 October 2026
Estimated completion	20 January 2027
Sites	1 location across China

Drugs / interventions 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

Conditions studied

• SCLC, Extensive Stage — all drugs for SCLC, Extensive Stage →
• Neuroendocrine Tumors — all drugs for Neuroendocrine Tumors →

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Who can join

Adults 18 to 75, any sex, with SCLC, Extensive Stage or Neuroendocrine Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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). The primary goal of the study is to determine the safety and tolerability of this new therapy and to preliminarily observe its anti-tumor effects.

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

1. Lymphodepletion Conditioning: Chemotherapy (Cyclophosphamide + Fludarabine) before cell infusion to clear lymphocytes in the body.
2. Cell Infusion: NEUK203-13 is administered via intravenous infusion, d1，d4 and d7 for three doses.
3. 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.