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CART-19 T Cell in CD19 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03896854
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Brief Summary:
This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD19 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19 positive relapsed or refractory acute myeloid leukemia.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Biological: CART-19 Phase 1 Phase 2

Detailed Description:
The patients will receive infusion of CART cells targeting CD19 to confirm the safety and efficacy of CD19 CART Cells in relapsed or refractory acute myeloid leukemia.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the Efficacy and Safety of CD19 Targeted Chimeric Antigen Receptor Engineered T Cell in the Treatment of Relapsed or Refractory CD19 Positive Acute Myeloid Leukemia (AML)
Actual Study Start Date : October 18, 2017
Estimated Primary Completion Date : January 18, 2020
Estimated Study Completion Date : January 28, 2022


Arm Intervention/treatment
Experimental: CD19 positive relapsed or refractory acute myeloid leukemia
MICM typing confirmed CD19 positive relapsed and refractory acute myeloid leukemia
Biological: CART-19
CART-19 Split intravenous infusion of CART-19 cells of (Dose escalating infusion of 1 - 20 x10^6 CART-19 cells/kg).




Primary Outcome Measures :
  1. Adverse events [ Time Frame: 12 months ]
    Adverse events are evaluated with CTCAE V4.03



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients with CD19+ relapsed/refractory acute myeloid leukemia
  • Age 6-65 years.
  • Left ventricular ejection fractions≥ 0.5 by echocardiography.
  • Creatinine < 1.6 mg/dL.
  • Aspartate aminotransferase/aspartate aminotransferase < 3x upper limit of normal.
  • Bilirubin <2.0 mg/dL.
  • Karnofsky performance status ≥ 60
  • Expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion Criteria:

  • Pregnant or lactating women.
  • Uncontrolled active infection.
  • Active hepatitis B or hepatitis C infection.
  • Class III/IV cardiovascular disability according to the New York Heart Association Classification.
  • HIV infection.
  • Patients with history of seizure
  • Active central nervous system leukemia

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 ClinicalTrials.gov identifier (NCT number): NCT03896854


Contacts
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Contact: Xiaowen Tang, Ph.D. (0086)51267781856 tangxiaowen@suda.edu.cn
Contact: Lei Yu, Ph.D. (0086)13818629089 ylyh188@163.com

Locations
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China, Jiangsu
The First Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215000
Contact: Xiaowen Tang, Ph.D.         
Sponsors and Collaborators
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Investigators
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Principal Investigator: Xiaowen Tang, Ph.D. The First Affiliated Hospital of Soochow University

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Responsible Party: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
ClinicalTrials.gov Identifier: NCT03896854    
Other Study ID Numbers: UnicarTherapy20190308
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms