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Recruiting Phase 1 / Phase 2

Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML

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About this study

This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting CD33 or CD123 or both sequentially in the treatment of Acute Myelocytic Leukemia.

Condition
AML, Acute Myeloid Leukemia, AML, Adult Recurrent, AML, Adult
Tested
CD123/CD33 CART
Sponsor
Essen Biotech

Who can join

Age
6 to 90 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 11

  • Minimum age: 6 years
  • Maximum age: 90 years
  • Study condition: AML, Acute Myeloid Leukemia, AML, Adult Recurrent, AML, Adult
  • Subjects with acute myeloid leukemia who voluntarily signed informed consent and met the following criteria:
  • Age older than 6 months.
  • Confirmed expression of CLL-1, CD123 and/or CD33 in blast AML 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 6

  • Severe 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, hepatitis B virus (HBV) or 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.
  • Patients, in the opinion of investigators, may not be able to comply with the study.

Where

1 site, 1 recruiting

District One Hospital

Beijing, Beijing Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.