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

Acute Myeloid Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03896854
• Other study ID #: UnicarTherapy20190308
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 18, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
• Contact: Xiaowen Tang, Ph.D.
• Phone: (0086)51267781856
• Email: tangxiaowen[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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).

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Adverse events are evaluated with CTCAE V4.03	12 months