Actively Recruiting
Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors
Led by Washington University School of Medicine · Updated on 2025-09-12
33
Participants Needed
1
Research Sites
316 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
M
Melanoma Research Alliance
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of advanced or metastatic melanoma confirmed by tissue analysis that has progressed after at least 12 weeks or a minimum of 2 doses of PD1/PDL1 therapy
- Age 18 years or older
- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2 at screening
- For Arm 1: eligibility to undergo apheresis to collect autologous NK cells
- For Arm 2: availability of an allogeneic NK cell donor who meets eligibility criteria
- Adequate organ function including total bilirubin less than 2 mg/dL, liver enzymes less than 3 times the upper limit of normal, normal kidney function or creatinine clearance above 40 mL/min/1.73 m², oxygen saturation at or above 90% on room air, and ejection fraction at or above 45%
- If previously had symptomatic central nervous system metastases, must be neurologically stable for at least 4 weeks and off anti-seizure and steroid medications for 7 days before lymphodepletion chemotherapy
- Ability to stop corticosteroids and other immune-suppressive drugs for at least 14 days before apheresis or lymphodepletion and continue until 30 days after ML NK cell infusion, with low-dose corticosteroids allowed if medically necessary
- Negative pregnancy test within 28 days before registration for women of childbearing potential
- Agreement to use two forms of contraception, including one barrier method, during the study and for 5 months after last dose of relatlimab
- Life expectancy longer than 12 weeks
- Ability and willingness to provide informed consent
You will not qualify if you...
- Active autoimmune disorders requiring immunosuppression beyond low-dose steroids
- History of severe immune-related side effects from prior cancer immunotherapy leading to permanent treatment stop
- Unresolved immune-related side effects greater than mild severity from previous immunotherapy
- Leptomeningeal disease, carcinomatous meningitis, or symptomatic central nervous system metastases
- Known allergy to any study treatment agents
- Health conditions that put the participant at unacceptable risk or prevent consent or participation
- Uncontrolled active infections including HIV, Hepatitis B or C
- Uncontrolled heart conditions or abnormal heart rhythms
- New or worsening lung infections not improved after appropriate treatment
- Recent use of investigational, off-label, or cytotoxic chemotherapy drugs within 14 days or five half-lives before apheresis
- Pregnant or breastfeeding
- Prior treatment with tumor infiltrating lymphocytes or organ transplant
- Additional active cancers requiring treatment within past 2 years except certain skin or in situ cancers
- Receipt of live or attenuated vaccine within 28 days before lymphodepletion
- For donors (Arm 2 only): under 18 years old, unable to tolerate leukapheresis, positive viral infections, pregnant or breastfeeding, or not meeting institutional donor guidelines
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
A
Alice Y Zhou, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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