Status:
UNKNOWN
Safety and Efficacy of Anti-CD123 CAR-T Therapy in Patients With Refractory/ Relapsed CD123+ Acute Myeloid Leukemia.
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
Wuhan Bio-Raid Biotechnology Co., Ltd.
Conditions:
CD123+ Acute Myeloid Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of anti-CD123 CAR-T cells in patients with refractory/relapsed CD123+ Acute Myeloid Leukemia.
Detailed Description
CD123 is a transmembrane subunit of the IL-3 receptor expressed on AML blasts. The investigators have conducted a third generationCD123-targeted CAR containing CD137 and CD28 costimulatory domains.Thi...
Eligibility Criteria
Inclusion
- Pathological and histological examination confirmed CD123+ refractory or relapsed Acute Myeloid Leukemia.
- A. Diagnostic criteria for recurrent AML: After complete remission (CR), leukemia cells or bone marrow primordial cells \> 0.050 (except for bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia cell infiltration appears again in peripheral blood.
- B．Diagnostic criteria for refractory AML(Meeting one of the following)
- i. ineffectiveness after the first standard regimen treatment of 2 courses.
- ii. patients relapse within 12 months after consolidation and intensive treatment after CR.
- iii. Patients relapse 12 months later and fail to respond to conventional chemotherapy.
- iv. Patients with two or more recurrences.
- v. Patients with persistent extramedullary leukemia.
- vi. Patients with recurrence after CR and unsuitable for HSCT (auto/allo-HSCT).
- Aged 18 to 70 years (including 18 and 70 years old).
- At least one measurable or evaluable lesion：AML patients with positive or relapsed positive bone marrow MRD.
- ECOG≤ 2 and expected lifetime ≥3 months.
- Adequate organ function:
- A. Liver function: ALT/AST≤3 ULN. Total bilirubin≤2 ULN.
- B. Renal function: eGFR\> 60 mL/min/1.73 m2, or creatinine clearance ≥45mL/min.
- C. Lung function: Carbon Monoxide (DLCO) or Forced Expiratory Volume in the first second (FEV1) \> 45% predicted.
- D. Cardiac function: LVEF ≥ 50%.
- The patients did not receive any anticancer treatments such as chemotherapy, radiotherapy and immunotherapy (such as immunosuppressive drugs) within 4 weeks before admission, and the toxicity related to previous treatments had returned to \< 1 level at admission (except for low toxicity such as alopecia).
- Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.
- Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent.
Exclusion
- Women who are pregnant (urine/blood pregnancy test positive) or lactating.
- Male or female with a conception plan in the past 1 years.
- Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment.
- Uncontrolled infectious disease within 4 weeks prior to enrollment.
- Active hepatitis B/C virus.
- HIV infected patients.
- Suffering from a serious autoimmune disease or immunodeficiency disease.
- The patient is allergic and is allergic to macromolecular biopharmaceuticals such as antibodies or cytokines.
- The patient participated in other clinical trials within 6 weeks prior to enrollment.
- Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids).
- Suffering from mental illness.
- Patient has drug abuse/addiction.
- Central nervous system involvement.
- According to the investigator's judgment, the patient has other unsuitable grouping conditions.
Key Trial Info
Start Date :
July 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04014881
Start Date
July 6 2019
End Date
July 1 2022
Last Update
August 7 2019
Active Locations (1)
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1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022