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Memory-like Natural Killer (NK) Cell Therapy in Patients With Renal Cell Carcinoma or Urothelial Carcinoma | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

Memory-like Natural Killer (NK) Cell Therapy in Patients With Renal Cell Carcinoma or Urothelial Carcinoma

A Phase 0 Pilot Study of Memory-like Natural Killer (NK) Cell Immune Therapy in Patients With Renal Cell Carcinoma or Urothelial Carcinoma

NCT06318871•Dana-Farber Cancer Institute

View on ClinicalTrials.gov

Summary

The goal of this research study is to establish the safety and then to explore the effectiveness of infusing the combination of cytokine-induced memory-like (CIML) natural killer (NK) cells, a type of immune cell in the blood that is collected and bathed in special proteins to help identify and treat curtained advanced cancers, combined with low dose IL-2, which is a cytokine that activates immune cells, in advanced clear cell renal cell carcinoma and urothelial carcinoma. Names of the study therapies involved in this study are/is: * CIML NK cell therapy (a NK cell therapy) * IL-2 (a type of cytokine)

Detailed Description

The purpose of this research study is to obtain information on the feasibility of CIML NK cell therapy with IL-2 to treat advanced clear cell renal cell carcinoma and urothelial carcinoma. This is the first time that the specific combination of CIML NK cells and IL-2 will be given to humans. The U.S. Food and Drug Administration (FDA) has not approved CIML NK cells post Maintenance Culture as a treatment for renal cell carcinoma or urothelial carcinoma. The FDA has approved IL-2 as a treatment for renal cell carcinoma but the dose used will be lower than the approved dose, as IL-2 is intended to support the CIML NK cells. This research study involves screening for eligibility, collection of natural killer (NK) cells in a process called leukapheresis, treatment visits, X-rays, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, Positron Emission Tomography (PET) scans, blood tests, urine tests, echocardiograms, electrocardiograms (ECGs), and tumor biopsies. Participants will be in this research study for up to 5 years from the CIML NK cell infusion. It is expected that about 10 people will take part in this research study. This research is supported by a grant from the Kidney Cancer Association.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed, advanced or metastatic clear cell renal cell carcinoma, translocation renal cell carcinoma, chromophobe renal cell carcinoma, or urothelial carcinoma. The presence of rhabdoid or sarcomatoid differentiation is permitted if a clear cell or urothelial carcinoma component is also present.
•Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for nonnodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 11 (Measurement of Effect) for the evaluation of measurable disease.
•Age ≥18 years. Because no dosing or adverse event data are currently available on the use of CIML NK cells in participants \<18 years of age, children are excluded from this study, but would be eligible for future pediatric trials.
•Participants with clear cell RCC or UC must have progression after prior treatment failure with at least one PD-1/PD-L1 immune checkpoint inhibitor that is FDA approved for treatment of UC or RCC as of the date of informed consent.
•Patients with renal cell carcinoma should also have prior treatment failure with at least one prior VEGFR TKI, or contraindication to VEGFR TKIs as determined by the treating clinician. Patients with urothelial carcinoma should have either prior treatment failure with ≥1 prior cytotoxic chemotherapy or antibody-drug conjugate. There is no limit on the number of prior lines of therapy received.
•ECOG performance status ≤1 (Karnofsky ≥80%, see Appendix A).
•Participants must meet the following organ and marrow function as defined below:
•* absolute neutrophil count ≥1,000/mcL
•* hemoglobin ≥8g/dL (prior transfusion permitted)
•* platelets ≥75,000/mcL
+23 more criteria

Exclusion Criteria

•Participants who have had anti-tumor chemotherapy or other investigational agents within 2 weeks prior to enrollment(4 weeks for nitrosoureas or mitomycin C), or immunotherapy within 4 weeks prior.
•Persisting toxicity related to prior therapy (NCI CTCAE Grade \> 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
•Prior recipients of solid organ transplantation.
•Participants who are receiving any other investigational agents.

Locations (2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

August 28, 2024

Primary Completion Date

February 28, 2027

Completion Date

July 28, 2031

Last Updated

January 29, 2026

Enrollment

ESTIMATED participants

Conditions

Renal CarcinomaRenal Cell CarcinomaUrothelial CarcinomaChromophobe Renal Cell CarcinomaTranslocation Renal Cell Carcinoma

Interventions

Cytokine Induced Memory-like Natural Killer (CIML NK) Cells

BIOLOGICAL

Interleukin-2 (IL-2)

DRUG

Contacts

Wenxin Xu, MD

CONTACT

(617) 632-6534 wenxin_xu1@dfci.harvard.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Memory-like Natural Killer (NK) Cell Therapy in Patients With Renal Cell Carcinoma or Urothelial Carcinoma

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

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