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

Phase 1

Recruiting

• Conditions: B-cell Acute Lymphocytic Leukemia

• Registration Number: NCT03064269
• Lead Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2017-02-18
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-27
• Study Start: 2017-03-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, China