Not yet recruiting NCT07621471
IL-15 Enhanced NK Cell Therapy for Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IL-15 enhanced engineered NK cells, IL-15 Enhanced Engineered NK Cells.
- Who it may be relevant to
- Registry conditions: Solid Tumors, Metastatic Cancer. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-Arm Clinical Study of IL-15 Enhanced Engineered NK Cells for Refractory Relapsed/Metastatic Solid Tumors
Overview
A single-arm, Phase 1 study evaluating safety, tolerability, and preliminary efficacy of IL-15 enhanced engineered NK cells in patients with refractory relapsed or metastatic solid tumors.
Interventions
- Drug IL-15 enhanced engineered NK cells
Genetically engineered NK cells expressing IL-15. Administered intravenously. See protocol for dose details. - Biological IL-15 Enhanced Engineered NK Cells
Genetically engineered NK cells expressing IL-15
Primary outcome measures
- Incidence of Dose-Limiting Toxicity (DLT) [Time frame: Within 28 days after first infusion]
Secondary outcome measures (4)
- Objective Response Rate (ORR) [Time frame: Every 4 weeks for the first 6 months, then every 12 weeks through 24 months]
- Duration of Response (DOR) [Time frame: From date of first documented response until date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months]
- Progression-Free Survival (PFS) [Time frame: From date of enrollment until date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months]
- Overall Survival (OS) [Time frame: From date of enrollment until date of death from any cause, assessed up to 24 months]
Eligibility criteria
Inclusion criteria
- Age 18-70 years;
- ECOG 0-1;
- histopathologically confirmed metastatic or recurrent solid tumors (breast, liver, lung, etc.);
- failed prior standard therapy;
- >=1 measurable lesion per RECIST 1.1;
- adequate bone marrow, liver, kidney, and coagulation function;
- recovered from prior treatment toxicities;
- signed informed consent.
Exclusion criteria
- Pregnancy/lactation;
- other malignancy within 5 years (except cured localized tumors);
- active autoimmune disease or immunodeficiency;
- uncontrolled cardiovascular disease or infection;
- active TB;
- positive HBsAg/HBcAb or HCV antibody (unless viral load undetectable);
- positive syphilis antibody;
- major surgery or vaccination within 28 days;
- prior cell therapy;
- severe allergy to study drugs;
- investigator judged unsuitable.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xinqiao Hospital — Chongqing
Identifiers
NCT: NCT07621471 · 2026-08-02