OncoMatch/Clinical Trials/NCT06066359
Phase I/II Trial of Cord Blood-Derived NK Cells Genetically Engineered With NY-ESO-1 TCR/IL-15 Cell Receptor for Relapsed/Refractory Multiple Myeloma
Is NCT06066359 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Fludarabine phosphate and Cyclophosphamide for myeloma.
Treatment: Fludarabine phosphate · Cyclophosphamide · NY-ESO-1 TCR/IL-15 NK — To find the recommended dose of NY-ESO-1 TCR/IL-15 NK cells that can be given to patients with relapsed or refractory MM. To learn if the dose of NY-ESO-1 TCR/IL-15 NK cells found in Part A can help to control the disease.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Required: CTAG1B expression by immunohistochemistry
expression of NY-ESO-1 by immunohistochemistry in the pre-enrollment tumor sample
Required: HLA-A A*02:01 positive (A*02:01 positive)
Patients are HLA-A*02:01 positive on HLA typing
Prior therapy
Must have received: proteasome inhibitor
including exposure to at least one proteasome inhibitor
Must have received: ImiD
including exposure to at least one ... ImiD
Must have received: anti-CD38 antibody
including exposure to at least one ... anti-cd38 antibody
Must have received: BCMA targeted agent
including exposure to at least one ... bcma targeted agent
Lab requirements
Blood counts
Absolute neutrophil count (ANC) >=1000 /µL; Hemoglobin >=8 g/dL; Platelet count >=50,000 /µL; Adequate bone marrow function without the need for transfusion in the last 7 days unless the pancytopenia is due to marrow replacement by myeloma.
Kidney function
Serum creatinine <= 1.5 mg/dL or estimated Glomerular Filtration Rate (eGFR using the CKI-EPI equation) >= 45 ml/min/1.73 m2.
Liver function
ALT/AST <= 2.5 x ULN or <= 5 x ULN if documented liver metastases, Total bilirubin <= 1.5 mg/dL, except in subjects with Gilbert's Syndrome in whom total bilirubin must be <= 3.0 mg/dL. No history of liver cirrhosis. No ascites.
Cardiac function
Cardiac ejection fraction >= 50%, no clinically significant pericardial effusion as determined by an ECHO or MUGA, and no uncontrolled arrhythmias or symptomatic cardiac disease.
Adequate organ function: Renal: Serum creatinine <= 1.5 mg/dL or eGFR >= 45 ml/min/1.73 m2. Hepatic: ALT/AST <= 2.5 x ULN or <= 5 x ULN if documented liver metastases, Total bilirubin <= 1.5 mg/dL, except in subjects with Gilbert's Syndrome in whom total bilirubin must be <= 3.0 mg/dL. No history of liver cirrhosis. No ascites. Cardiac: Cardiac ejection fraction >= 50%, no clinically significant pericardial effusion as determined by an ECHO or MUGA, and no uncontrolled arrhythmias or symptomatic cardiac disease. Pulmonary: No clinically significant pleural effusion (per PI discretion), baseline oxygen saturation > 92% on room air.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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