Determining the Mechanisms of Loss of CAR T Cell Persistence

Acute Lymphoblastic Leukemia, in Relapse Clinical Trial

— CARPERS  

Official title:

Determining the Mechanisms of Loss of CAR T Cell Persistence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05809284
• Other study ID #: UCL/156503
• Status: Recruiting
• Start date: October 18, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: University College, London
• Contact: CARPERS Trial Manager
• Phone: 442031084189
• Email: ctc.carpers[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A prospective observational study of pediatric and young adult acute lymphoblastic leukaemia (ALL) patients treated with CD19 chimeric antigen receptor T-cells (CAR-T cells). The study will examine changes in CAR-T persistence over time and causal factors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 25 Years

Eligibility

Inclusion Criteria:

1. Children and young adults (age 25 years or younger) with relapsed/refractory ALL who are planned to receive licensed CD19-targeted CAR-T cell treatment (Tisagenlecleucel)

2. Written informed consent

Exclusion Criteria:

1. Patients receiving an alternate CD19-directed CAR T-cell product on a clinical trial

2. Any reason that in the opinion of the investigator, patients won't be able to adhere to the protocol

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia Not Having Achieved Remission
• Acute Lymphoblastic Leukemia With Failed Remission
• Acute Lymphoblastic Leukemia, Adult
• Acute Lymphoblastic Leukemia, in Relapse
• Acute Lymphoblastic Leukemia, Pediatric
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital	London
United Kingdom	University College London Hospital	London
United Kingdom	Royal Manchester Children's Hospital	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to circulating CAR-T cell loss	CAR-T persistence will be measured in the central lab from blood samples.	Through study completion, until the last patient reaches 1 year post-infusion