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NCT05809284 Clinical Trial

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: Not yet recruiting

Administrative data
NCT number NCT05809284
Other study ID # UCL/156503
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 31, 2023
Est. completion date December 1, 2025

Study information
Verified date March 2023
Source University College, London
Contact CARPERS Trial Manager
Phone 442031084189
Email ctc.carpers@ucl.ac.uk
Is FDA regulated No
Health authority
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 Not yet 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

Study Design

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
n/a

Sponsors (1)
Lead Sponsor Collaborator
University College, London

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
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