Engineered T cells for the treatment of B-cell leukemia

Phase 1

• Conditions: B-cell leukemia; CAR-CD19 T cell

• Registration Number: TCTR20160921001
• Lead Sponsor: TCELS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-21
• Last Update Posted: 19 August 2024
• Study Completion: 2024-08-25

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Age less than 25 years
2. Treated at Ramathibodi Hospital
3. Diagnosed with relapsed/refractory B-cell leukemia with expressing CD19
4. Bilirubin less than 4.5mg/dL
5. AST less than 150 U/dL
6. Glomerular filtration rate 50 or more than 50ml/1.73m2/min
7. Available stem cell donor in family members
8. No pregnancy
9. Signed informed consent

Exclusion Criteria

Denied to be enrolled in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantity of CAR-CD19 T cell 12 months cell/kg

Secondary Outcome Measures

Name	Time	Method
event free rate 1 year cases