IL-15 Enhanced NK Cell Therapy for Solid Tumors

NCT07621471 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2026-08-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumors; Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Dose-Limiting Toxicity (DLT)

  Within 28 days after first infusion

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Every 4 weeks for the first 6 months, then every 12 weeks through 24 months

• Duration of Response (DOR)

  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)

  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)

  From date of enrollment until date of death from any cause, assessed up to 24 months

Other Outcomes (1)

• Expansion and persistence of IL-15 enhanced engineered NK cells and cytokine levels

  Baseline (Day 0), Day 1, Day 3, Day 7, Day 14, Day 28, then every 4 weeks through 6 months, then every 12 weeks through 12 months

Study Arms (1)

IL-15 Enhanced Engineered NK Cells

EXPERIMENTAL

Single arm. Patients receive IL-15 enhanced engineered NK cells after lymphodepletion chemotherapy.

Drug: IL-15 enhanced engineered NK cells; Biological: IL-15 Enhanced Engineered NK Cells

Interventions

IL-15 Enhanced Engineered NK Cells DRUG

Genetically engineered NK cells expressing IL-15. Administered intravenously. See protocol for dose details.

IL-15 Enhanced Engineered NK Cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genovn Therapeutics (Suzhou) Co., Ltd.: lead

Study Sites (1)

Xinqiao Hospital

Chongqing, China

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: IL-15 enhanced engineered NK cells in patients with refractory relapsed or metastatic solid tumors.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)