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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 (Jun 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 Jun 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

Treatments studied

Chemotherapy

Fludarabine PhosphateCyclophosphamide

Other

CAR.5/IL15-transduced CB-NK cells

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

Demographics

Ages ≤ 80

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 →

Frequently asked questions

Is NCT05110742 currently recruiting?

Yes, this trial is currently recruiting patients.

Does this trial require CD5?

Yes, CD5 expression ≥ 30% 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.

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