Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05629546
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cytokine-induced memory-like natural killer cells — BIOLOGICAL
    Cell product processing is performed at the Siteman Cancer Center Biological Therapy Core Facility (BTCF).
  • Relatilmab — BIOLOGICAL
    Standard of care
  • Nivolumab — BIOLOGICAL
    Standard of care

Study Details

This is a Phase 1 open-label, study designed to characterize the safety, tolerability, and preliminary anti-tumor activity of memory-like natural killer cells (ML NK) in combination with nivolumab and relatlimab in subjects with advanced and/or metastatic melanoma. There will be two arms to test the variables of ML NK cell source. ML NK cells from an autologous source will be used for Arm 1, and ML NK cells from an allogeneic source will be used for Arm 2. The investigators hypothesize that ML NK cells from either an autologous source or allogeneic source are safe and tolerable in subjects with advanced and/or metastatic melanoma.

Key Dates

Start date
Nov 6, 2024
Status verified
Sep 2025
Primary completion
Feb 28, 2029
Completion
Nov 30, 2030

Study Design

Enrollment
33 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Autologous: Memory-like natural killer cells + nivolumab + relatilimab
    * Subjects enrolled into arm 1 will receive autologous ML NK cells on Day 0. * Relatlimab and nivolumab will be initiated at day 29 and continue every 28 days for 11 cycles, or until unacceptable toxicity, or progression, whichever is earlier.
  • Experimental: Arm 2: Allogeneic: Memory-like natural killer cells + nivolumab + relatilimab
    * Subjects with a haploidentical donor will enroll into Arm 2 * Subjects will receive the IV infusion of ML NK cells on Day 0. * Relatlimab and nivolumab will be initiated at day 29 and continue every 28 days for 11 cycles, or until unacceptable toxicity, or progression, whichever is earlier.
  • No Intervention: Allogeneic Donors

Primary Outcome Measure

For treatment with cells from an autologous source: Incidence and severity of adverse events [ Time Frame: From start of treatment through end of safety follow-up (estimated to be 15 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Alice Y Zhou, M.D., Ph.D.
[email protected]
314-362-5677
Alice Y Zhou, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Todd A Fehniger, M.D., Ph.D. (SUB_INVESTIGATOR)
Tanner M Johanns, M.D., Ph.D. (SUB_INVESTIGATOR)
George Ansstas, M.D. (SUB_INVESTIGATOR)
Charles Kaufman, M.D., Ph.D. (SUB_INVESTIGATOR)
Ryan Fields, M.D. (SUB_INVESTIGATOR)
Armin Ghobadi, M.D. (SUB_INVESTIGATOR)
Amanda Cashen, M.D. (SUB_INVESTIGATOR)
Feng Gao, M.D., Ph.D., MPH, MS (SUB_INVESTIGATOR)
Jesse Keller, M.D. (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Washington University School of Medicine· St Louis, MO

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