CART-19 T Cell in CD19 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Primary Purpose
Acute Myeloid Leukemia
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CART-19
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia
Eligibility 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
Sites / Locations
- The First Affiliated Hospital of Soochow UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CD19 positive relapsed or refractory acute myeloid leukemia
Arm Description
MICM typing confirmed CD19 positive relapsed and refractory acute myeloid leukemia
Outcomes
Primary Outcome Measures
Adverse events
Adverse events are evaluated with CTCAE V4.03
Secondary Outcome Measures
Full Information
NCT ID
NCT03896854
First Posted
March 25, 2019
Last Updated
May 18, 2022
Sponsor
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03896854
Brief Title
CART-19 T Cell in CD19 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2017 (Actual)
Primary Completion Date
January 18, 2023 (Anticipated)
Study Completion Date
January 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CD19 positive relapsed or refractory acute myeloid leukemia
Arm Type
Experimental
Arm Description
MICM typing confirmed CD19 positive relapsed and refractory acute myeloid leukemia
Intervention Type
Biological
Intervention Name(s)
CART-19
Intervention Description
CART-19 Split intravenous infusion of CART-19 cells of (Dose escalating infusion of 1 - 20 x10^6 CART-19 cells/kg).
Primary Outcome Measure Information:
Title
Adverse events
Description
Adverse events are evaluated with CTCAE V4.03
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaowen Tang, Ph.D.
Phone
(0086)51267781856
Email
tangxiaowen@suda.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Yu, Ph.D.
Phone
(0086)13818629089
Email
ylyh188@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaowen Tang, Ph.D.
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaowen Tang, Ph.D.
12. IPD Sharing Statement
Learn more about this trial
CART-19 T Cell in CD19 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
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