Health TrialsbyHealthPanel

IL-15 Enhanced NK Cell Therapy for Solid Tumors

ConditionsSolid TumorsMetastatic Cancer
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGenovn Therapeutics (Suzhou) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-70 years;

ECOG 0-1;

histopathologically confirmed metastatic or recurrent solid tumors (breast, liver, lung, etc.);

failed prior standard therapy;

Disqualifiers

Pregnancy/lactation;

other malignancy within 5 years (except cured localized tumors);

active autoimmune disease or immunodeficiency;

uncontrolled cardiovascular disease or infection;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

    Biological/Vaccine

    Genetically engineered NK cells expressing IL-15

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: IL-15 Enhanced Engineered NK CellsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of Dose-Limiting Toxicity (DLT)

Time frame
Within 28 days after first infusion

Secondary outcomes

1

Objective Response Rate (ORR)

Time frame
Every 4 weeks for the first 6 months, then every 12 weeks through 24 months
2

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
3

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
4

Overall Survival (OS)

Time frame
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

Time frame
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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genovn Therapeutics (Suzhou) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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