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 (Jun 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
Treatments studied
Chemotherapy
Other
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
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06066359 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received proteasome inhibitor and ImiD.
Does this trial require CTAG1B?
Yes, CTAG1B expression by immunohistochemistry is a required biomarker for enrollment.
Does this trial require HLA-A?
Yes, HLA-A A*02:01 positive is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages