CD19/CD22-targeted Chimeric Antigen Receptor Engineered T Cell (CART) in B-Cell Acute Lymphoblastic Leukemia.

Leukemia, B-cell Clinical Trial

Official title:

Pilot Study of the Efficacy and Safety of Cluster of Differentiation Antigen 19 (CD19) /Cluster of Differentiation Antigen 22 (CD22) CART in the Treatment of Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03614858
• Other study ID #: UnicarTherapy201807
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 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/CD22 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19/CD22 positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Description:

The patients will receive infusion of CART cells targeting CD19 and CD22 to confirm the safety and efficacy of CD19/CD22 CART Cells in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• 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+/CD22+ relapsed/refractory B-cell acute lymphoblastic leukemia who have a dismal prognosis (estimated survival from several months to <2 year). The study will enroll 20 evaluable patients as follows:

• 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

• Leukemia
• Leukemia, B-cell
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• CART-19/22
Split intravenous infusion of CART-19/22 cells of (Dose escalating infusion of 1 - 20 x10^6 CART-19/22 cells/kg).

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd	The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

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