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OncoMatch/Clinical Trials/NCT05110742

Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances

Is NCT05110742 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Fludarabine Phosphate and Cyclophosphamide for hematological malignancy.

Phase 1/2RecruitingM.D. Anderson Cancer CenterNCT05110742Data as of May 2026

Treatment: Fludarabine Phosphate · Cyclophosphamide · CAR.5/IL15-transduced CB-NK cellsTo determine the safety, efficacy and optimal cell dose of CAR 5/IL15-transduced CB-NK cells in patients with relapsed/refractory T-cell malignances, mantle cell lymphoma, and chronic lymphocytic leukemia. The efficacy and optimal dose will be identified for individual diseases.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Non-Hodgkin Lymphoma

Multiple Myeloma

Myelodysplastic Syndrome

Chronic Lymphocytic Leukemia

Biomarker criteria

Required: CD5 expression ≥ 30% (≥ 30%)

expression of CD5 in the pre-enrollment tumor sample ≥ 30% measured by immunohistochemistry or flow cytometry

Prior therapy

Min 2 prior lines

Lab requirements

Kidney function

Serum creatinine ≤ 2.0ULN or eGFR ≥ 30 ml/min/1.73 m2

Liver function

ALT/AST ≤ 3.0 x ULN or ≤ 5 x ULN if documented liver involvement with disease, Total bilirubin ≤ 2.0ULN, except in subjects with Gilbert's Syndrome in whom total bilirubin must be ≤ 3.0 mg/dL. No history of liver cirrhosis.

Cardiac function

Cardiac ejection fraction ≥ 40%, 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 ≤ 2.0ULN or eGFR ≥ 30 ml/min/1.73 m2. Hepatic: ALT/AST ≤ 3.0 x ULN or ≤ 5 x ULN if documented liver involvement with disease, Total bilirubin ≤ 2.0ULN, except in subjects with Gilbert's Syndrome in whom total bilirubin must be ≤ 3.0 mg/dL. No history of liver cirrhosis. Cardiac: Cardiac ejection fraction ≥ 40%, no clinically significant pericardial effusion as determined by an ECHO or MUGA, and no uncontrolled arrhythmias or symptomatic cardiac disease. Pulmonary: No clinically significant lung involvement, per PI discretion, pleural effusion, 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 →

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