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OncoMatch/Clinical Trials/NCT06318871

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

Is NCT06318871 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Cytokine Induced Memory-like Natural Killer (CIML NK) Cells and Interleukin-2 (IL-2) for renal carcinoma.

Early Phase 1RecruitingDana-Farber Cancer InstituteNCT06318871Data as of May 2026

Treatment: Cytokine Induced Memory-like Natural Killer (CIML NK) Cells · Interleukin-2 (IL-2)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)

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Extracted eligibility criteria

Cancer type

Renal Cell Carcinoma

Urothelial Carcinoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: anti-PD-1 therapy — clear cell RCC or UC

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

Must have received: VEGFR inhibitor — renal cell carcinoma

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

Must have received: cytotoxic chemotherapy — urothelial carcinoma

Patients with urothelial carcinoma should have either prior treatment failure with ≥1 prior cytotoxic chemotherapy or antibody-drug conjugate

Cannot have received: anti-tumor chemotherapy

Exception: within 2 weeks prior to enrollment (4 weeks for nitrosoureas or mitomycin C)

Participants who have had anti-tumor chemotherapy or other investigational agents within 2 weeks prior to enrollment(4 weeks for nitrosoureas or mitomycin C)

Cannot have received: immunotherapy

Exception: within 4 weeks prior

immunotherapy within 4 weeks prior

Cannot have received: investigational agent

Participants who are receiving any other investigational agents

Lab requirements

Blood counts

absolute neutrophil count ≥1,000/mcL; hemoglobin ≥8g/dL (prior transfusion permitted); platelets ≥75,000/mcL; no laboratory evidence of ongoing hemolysis in opinion of investigator

Kidney function

creatinine ≤ 2.0 OR GFR ≥40 mL/min/1.73 m2 for participants with creatinine levels above institutional ULN

Liver function

total bilirubin ≤ 1.5 × institutional ULN (except if secondary to Gilbert's, then < 3 x ULN); AST(SGOT)/ALT(SGPT) ≤3.0 × institutional ULN

Cardiac function

oxygen saturation ≥ 90% on room air; left ventricular ejection fraction > 40%; NYHA class 2B or better

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; total bilirubin ≤ 1.5 × institutional ULN (except if secondary to Gilbert's, then < 3 x ULN); AST(SGOT)/ALT(SGPT) ≤3.0 × institutional ULN; creatinine ≤ 2.0 OR GFR ≥40 mL/min/1.73 m2 for participants with creatinine levels above institutional ULN; oxygen saturation ≥ 90% on room air; left ventricular ejection fraction > 40%; No laboratory evidence of ongoing hemolysis in opinion of investigator

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Brigham and Women&#39;s Hospital · Boston, Massachusetts
  • Dana-Farber Cancer Institute · Boston, Massachusetts

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