Memory-Like Natural Killer Cells with Nivolumab and Relatlimab for Advanced Melanoma
This study is for people with advanced or metastatic melanoma that has progressed after prior checkpoint inhibitor treatment. It is testing a combination of treatments: memory-like natural killer cells (a type of immune cell), nivolumab, and relatlimab. Researchers want to see if this combination is safe and tolerable. There are two groups in the study, one receiving memory-like natural killer cells from your own body (autologous) and another receiving them from a donor (allogeneic). The study aims to enroll 33 participants aged 18 and older. The main goal is to track any side effects and how severe they are.
- Study design
- This is a Phase 1, open-label study with two arms, designed to enroll 33 participants. It is testing two different sources for the memory-like natural killer cells.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for safety from the start of treatment through the end of safety follow-up, estimated to be 15 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05629546
Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors
Recruiting
PHASE1Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~33 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Cytokine-induced memory-like natural killer cellsRelatilmabNivolumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
For treatment with cells from an autologous source: Incidence and severity of adverse events
Measured over From start of treatment through end of safety follow-up (estimated to be 15 months)
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMissouri1
Study leadership
- Alice Y Zhou, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Diagnosis of histologically confirmed advanced or metastatic melanoma that has progressed after at least 12 weeks or a minimum of 2 doses of treatment with a standard of care PD1/PDL1 containing therapy (nivolumab, pembrolizumab, atezolizumab, or durvalumab).
Age: ≥18 years of age
Have an Eastern Cooperative Oncology Group Performance Status (ECOG) ≤ 2 at screening Form Arm 1 only: Patients must meet the eligibility criteria to undergo apheresis to obtain autlogous NK cells.
For Arm 2 only: Patient must have an available allogeneic NK cell donor who meets the eligibility criteria.
Adequate organ function as defined below:
Total bilirubin \< 2 mg/dL
AST(SGOT)/ALT(SGPT) \< 3.0 x ULN
Creatinine within normal institutional limits OR creatinine clearance \> 40 mL/min/1.73 m\^2 by Cockcroft-Gault Formula
Oxygen saturation ≥ 90% on room air
Ejection fraction ≥ 45%
Patients with a prior history of symptomatic CNS metastases must have received treatment and be neurologically stable for at least for 4 weeks and off anti-seizure medication and steroids for 7 days prior to initiation of LDC.
Able to be off corticosteroids and any other immune suppressive medications for at least 14 days prior to apheresis or lymphodepletion and continuing until 30 days after the infusion of the ML NK cells. However, use of physiological dosing of corticosteroids (defined as ≤15mg prednisone or equivalent) is permitted if deemed medically necessary.
Women of childbearing potential must have a negative pregnancy test within 28 days prior to study registration. Female and male patients (along with their female partners) must agree to use two forms of acceptable contraception, including one barrier method, throughout participation in the study and for at least 5 months after the last dose of relatlimab.
Life expectancy \>12 weeks
Ability to understand and willingness to sign an IRB approved written informed consent document
Exclusion
Active autoimmune disorder requiring immunosuppression (physiologic steroids defined as ≤15mg prednisone or equivalent are acceptable).
Prior history of an immune-related Grade 3 or 4 AE attributed to prior cancer immunotherapy (other than endocrinopathy managed with either replacement therapy or asymptomatic elevation of serum amylase or lipase) that resulted in permanent discontinuation of the prior immunotherapeutic agent.
Patients with Grade ≤2 irAE who have not completely recovered from irAE (i.e. have residual toxicities \>Grade 1) related to prior cancer immunotherapy (other than endocrinopathy management with replacement therapy or stable vitiligo). Patients treated with corticosteroids for irAE must demonstrate absence of related signs or symptoms for ≥7 days following discontinuation of corticosteroids.
Leptomeningeal disease, carcinomatous meningitis, or symptomatic CNS metastases. Patients with asymptomatic brain metastasis with no pending intervention needed, or patients with treated CNS disease and stable for at least 4 weeks and off anti-seizure medication and steroids for 7 days prior to initiation of LDC are eligible.
Known hypersensitivity to one or more of the study agents.
Comorbidities and any conditions, that in the opinion of the investigator, that put the subject at unacceptable risk for study therapy or prevent the participant from consenting or participating in the study.
Uncontrolled and active systemic infections, including but not limited to HIV, Hepatitis B or C infection.
Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or EKG suggestive of acute ischemia or active conduction system abnormalities.
New progressive pulmonary infiltrates concerning for new or uncontrolled infectious process. Infiltrates attributed to infection must be stable/ improving after 1 week of appropriate therapy (4 weeks for presumed or proven fungal infections).
Received any investigational or off-label drugs, or cytotoxic chemotherapy within the 14 days or five half-lives (whichever is greater) prior to apheresis.
Pregnant or breastfeeding.
Subjects are not acceptable candidates if they received prior tumor infiltrating lymphocytes (TIL) therapy (either in the setting of clinical trial or standard of care if TIL therapy is FDA approved in the future), or an organ allograft.
Has a known additional malignancy that is progressing or required active treatment within the past 2 years. Note: participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg. Breast carcinoma, cervical cancer in situ) that has undergone potentially curative therapy are not excluded.
Received a live or attenuated vaccine within 28 days prior to the beginning of the lymphodepletion therapy.
Donor must be at least 18 years of age.
Donor must be willing, in general good health, and medically able to tolerate leukapheresis required for harvesting the NK cells for this study.
Donor must be negative for hepatitis, HTLV, and HIV on donor viral screen.
Donor may not be pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 30 days prior to apheresis.
Donor must be able to understand and willing to sign an IRB-approved written informed consent document.
Only haploidentical donors will be included.
Donor must meet the requirements of institutional donor guidelines, including the requirements of Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT) criteria.
Patient must be willing and medically able to tolerate leukapheresis required for harvesting the NK cells for this study.
Patient must be negative for hepatitis, HTLV, and HIV on the viral screen.
Patient may not be treated with any cytotoxic treatment within 2 weeks prior to leukapheresis.
What this trial measures
- For treatment with cells from an autologous source: Incidence and severity of adverse eventsFrom start of treatment through end of safety follow-up (estimated to be 15 months)
-As determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
- For treatment with cells from an allogeneic source: Incidence and severity of adverse eventsFrom start of treatment through end of safety follow-up (estimated to be 15 months)
-As determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)