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RecruitingPhase 1NCT05995041

Universal CAR-T Cells Targeting AML

Universal CAR T Cells for the Treatment of Acute Myeloid Leukemia

Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

30 participants

Start Date

Oct 31, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

Summary

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of universal CAR T-cell products targeting CLL-1, CD33, CD38 and CD123 in patients with relapsed and refractory AML. The study also aims to learn more about the function of the universal CAR T cells and their persistency in AML patients.

Eligibility

Min Age: 6 MonthsMax Age: 75 Years

Inclusion Criteria7

  • Age older than 6 months.
  • Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts by immuno-histochemical staining or flow cytometry.
  • Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 months.
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL.
  • Hgb≥80g/L.
  • No cell separation contraindications.
  • Abilities to understand and the willingness to provide written informed consent.

Exclusion Criteria8

  • Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
  • Active bacterial, fungal or viral infection not controlled by adequate treatment.
  • Known HIV or active hepatitis C virus (HCV) infection.
  • Pregnant or nursing women may not participate.
  • Use of glucocorticoid for systemic therapy within one week prior to entering the trial.
  • Previous treatment with any gene therapy products.
  • The bone marrow AML burden (MRD) is above 50%.
  • Patients, in the opinion of investigators, may not be able to comply with the study.

Interventions

BIOLOGICALCLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cells

Infusion of CLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cells

Locations(1)

Shenzhen Geno-Immune Medical Institute

Shenzhen, Guangdong, China

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NCT05995041

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