CART-19 T Cell in CD19 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
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)
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2017
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 18, 2017
CompletedFirst Submitted
Initial submission to the registry
March 25, 2019
CompletedFirst Posted
Study publicly available on registry
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedNovember 29, 2023
November 1, 2023
7.2 years
March 25, 2019
November 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events
Adverse events are evaluated with CTCAE V4.03
12 months
Study Arms (1)
CD19 positive relapsed or refractory acute myeloid leukemia
EXPERIMENTALMICM typing confirmed CD19 positive relapsed and refractory acute myeloid leukemia
Interventions
CART-19 Split intravenous infusion of CART-19 cells of (Dose escalating infusion of 1 - 20 x10\^6 CART-19 cells/kg).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaowen Tang, Ph.D.
The First Affiliated Hospital of Soochow University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2019
First Posted
April 1, 2019
Study Start
October 18, 2017
Primary Completion
December 31, 2024
Study Completion
December 31, 2025
Last Updated
November 29, 2023
Record last verified: 2023-11