OncoMatch/Clinical Trials/NCT05945849

CD33KO-HSPC Infusion Followed by CART-33 Infusion(s) for Refractory/Relapsed AML

Is NCT05945849 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CD33KO-HSPC; CART33 for leukemia, myeloid, acute.

Phase 1RecruitingUniversity of PennsylvaniaNCT05945849Data as of May 2026

Treatment: CD33KO-HSPC; CART33 — The purpose of this study is to provide a new type of treatment for AML. This treatment combines a new type of stem cell transplant along with treatment using chimeric antigen receptor (CAR) T cells that have been engineered to recognize and attack your AML cells. The first treatment is a modified stem cell transplant, using blood-forming stem cells donated from a healthy donor. From the same donor, we will also make CAR T-cells, which are leukemia fighting cells, which will be given to the patient via an infusion into the vein after the transplanted stem cells have started to grow healthy blood cells. The modification of the stem cell transplant means that the healthy bone marrow cells will be "invisible" to the CAR T-cells that are trying to kill the leukemia cells.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Performance status

ECOG 0–1(Restricted strenuous activity)

Lab requirements

Kidney function

Creatinine clearance > 40 ml/min

Liver function

ALT/AST must be ≤ 5x upper limit of normal unless related to disease and < 20 x upper limit of normal if related to disease; Direct bilirubin < 2.0 mg/dl, unless subject has Gilbert's syndrome (≤ 3.0 mg/dL)

Cardiac function

Left ventricular ejection fraction ≥ 40% as confirmed by echocardiogram or MUGA

Satisfactory organ function: Creatinine clearance > 40 ml/min; ALT/AST must be ≤ 5x upper limit of normal unless related to disease and < 20 x upper limit of normal if related to disease; Direct bilirubin < 2.0 mg/dl, unless subject has Gilbert's syndrome (≤ 3.0 mg/dL); Left ventricular ejection fraction ≥ 40% as confirmed by echocardiogram or MUGA; DLCO > 45% predicted

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

US trial sites

University of Pennsylvania · Philadelphia, Pennsylvania

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