CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia

B-cell Acute Lymphocytic Leukemia Clinical Trial

Official title:

CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03064269
• Other study ID #: UnicarTherapy
• Status: Recruiting
• Phase: Phase 1
• Start date: March 1, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
• Contact: Sheng-Li Xue, MD
• Phone: 86-13328008851
• Email: slxue[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.

Description:

CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia

2. ALT/ AST « 3x normal

3. Creatinine « 3x normal

4. Age:10-60.

5. Signed informed consent

Exclusion Criteria:

1. Active hepatitis B , hepatitis C or HIV infection

2. Uncontrolled active infection

3. Pregnancy or breast-feeding women

4. Survival less than four weeks

Related Conditions & MeSH terms

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

Intervention

Biological:
• CD19 CAR-T cells
CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells

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	The complete remission (CR) rate	The safety of the humanized CD19 CAR-T cells treatment will be evalated and the maximum tolerated dose will be determined	Participants will be followed for the duration of the treatment, an expected average of 12 months