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Study Evaluating Safety and Efficacy of CAR-T Cells Targeting CD123 in Patients With Acute Myelocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03796390
Recruitment Status : Unknown
Verified January 2019 by Hebei Senlang Biotechnology Inc., Ltd..
Recruitment status was:  Recruiting
First Posted : January 8, 2019
Last Update Posted : January 11, 2019
Hebei Yanda Ludaopei Hospital
Information provided by (Responsible Party):
Hebei Senlang Biotechnology Inc., Ltd.

Brief Summary:
This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting CD123 in the treatment of Acute Myelocytic Leukemia. A total of 15 patients are planned to be enrolled following up one year.

Condition or disease Intervention/treatment Phase
Acute Myelocytic Leukemia Biological: CD123 CAR-T cells Phase 1

Detailed Description:
Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc. may be potential in developing the corresponding CAR-T cells to treat patients whose tumors expressing those markers. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting CD123 in patients with Acute Myelocytic Leukemia. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Evaluating Safety and Efficacy of CAR-T Cells Targeting CD123 in Patients With Acute Myelocytic Leukemia
Actual Study Start Date : December 26, 2018
Estimated Primary Completion Date : November 6, 2020
Estimated Study Completion Date : June 6, 2021

Arm Intervention/treatment
Experimental: CD123 CAR-T cells
Patients will be be treated with CD123 CAR-T cells
Biological: CD123 CAR-T cells
Patients will be drawn 50-100 ml blood to obtain enough peripheral blood mononuclear cells (PBMC) for CAR-T manufacturing. The T cells will be purified from the PBMC, transduced with CAR lentiviral vector, expanded in vitro and then frozen for future administration. Chemotherapy will then be given. Following tumor burden reassessment, CD123 CAR-T cells will be infused.

Primary Outcome Measures :
  1. Tumor load [ Time Frame: Up to 12 months ]
    Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

Secondary Outcome Measures :
  1. CAR-T cell persistence [ Time Frame: Up to 12 months ]
    CAR-T cell persistence will be quantified with flow cytometry and qPCR; Percentage of CART cells in BM and copies of car per ug DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with acute myeloid leukemia who voluntarily signed informed consent and met the following criteria:

    1. Diagnosed as recurrent or refractory acute myeloid leukemia
    2. Tumor cells confirmed CD123 positive by Flow cytometry (FCM) or immunohistochemical detection, and CD123 positive rate >80%
    3. Age ≥ 2 years old, and <65 years old
    4. Estimated survival time is longer than 3 months from the date of signing the informed consent form
    5. KPS ≥ 80 points
    6. Important organs function need to meet the following conditions:

    1) EF>50%, and there is no obvious abnormality in ECG; 2) SpO2≥90%; 3)Cr≤2.5ULN; 4)ALT and AST≤4ULN, TBil≤50μmol/L 7. Subjects with a pregnancy plan must agree to take contraception before the enrollment study and after the study lasts for six months; if the subject is pregnant or suspects of pregnancy, the investigator should be notified immediately 8. Need to stop chemotherapy for at least 2 weeks before collecting the blood to manufacture CAR-T cells.

    9. For allogeneic hematopoietic stem cell transplantation subjects, it is necessary to stop the immunosuppressant against GVHD for at least 2 weeks before collecting autologous blood preparation, and if the donor is preparing blood, it is of no influence; 10. If the subject has a history of central nervous system (CNS) leukemia, the tumor cells in the cerebrospinal fluid need to be cleared and the white blood cell count <5 * 10^6 / L ,then can proceed lymphodepletion 11. Subjects who participate in other studies must withdraw other studies for 2 weeks before they can be enrolled.

Exclusion Criteria:

  1. Combine other diseases not effectively controlled, including but not limited to persistent or poorly controlled infections, symptomatic congestive heart failure, unstable angina, arrhythmia, poorly controlled lung disease or mental illness
  2. There are other active malignant tumors
  3. Combined serious infection and can not be effectively controlled
  4. Active hepatitis (HBV DNA or hepatitis C virus ribonucleic acid [HCVRNA] detection positive)
  5. Human immunodeficiency virus (HIV) infection or syphilis infection
  6. Have a history of severe allergies in biological products (including antibiotics)
  7. One month after discontinuation of immunosuppressants, allogeneic hematopoietic stem cell transplantation patients still have acute graft versus host response (GvHD)
  8. Female subjects are pregnant or lactating
  9. Systemic administration of glucocorticoids within one week prior to CAR-T treatment
  10. In the past, there was a prolonged QT interval or severe heart disease.
  11. Active autoimmune diseases requiring systemic immunosuppressive therapy
  12. The investigator believes that it may increase the risk of the subject or interfere with the study results.

Exit criteria:

  1. The subjects request to withdraw from the study before CAR-T infusion
  2. The subjects seriously violate the protocol
  3. Before CAR-T infusion, the following indicators are still abnormal after treatment:

1) EF>50%, and there is no obvious abnormality in ECG 2) SpO2≥90% 3)Cr≤2.5ULN(the upper limit of normal ) 4) ALT and AST ≤ 4ULN, TBil ≤ 50μmol / L 4.Not enough T cells for manufacture standard CAR-T cells 5. Other serious adverse events occurred

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03796390

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Contact: Peihua Lu, PhD&MD 008618611636172
Contact: Jianqiang Li, PhD&MD 008615511369555

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China, Hebei
Hebei Yanda Ludaopei Hospital Recruiting
Langfang, Hebei, China, 065000
Contact: Peihua Lu, PhD&MD    008618611636172   
Principal Investigator: Peihua Lu, PhD&MD         
Sub-Investigator: Jianqiang Li, PhD&MD         
Sponsors and Collaborators
Hebei Senlang Biotechnology Inc., Ltd.
Hebei Yanda Ludaopei Hospital
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Study Chair: Peihua Lu, PhD&MD Hebei Yanda Ludaopei Hospital
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Responsible Party: Hebei Senlang Biotechnology Inc., Ltd. Identifier: NCT03796390    
Other Study ID Numbers: Daopei CD123CAR-T
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hebei Senlang Biotechnology Inc., Ltd.:
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type