Determining the Mechanisms of Loss of CAR T Cell Persistence | NCT05809284

Studies
Determining the Mechanisms of Loss of CAR T Cell Persistence

NCT05809284

Sponsor

University College, London

Status

Unknown status

Last Update Posted

May 23, 2024Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Acute Lymphoblastic Leukemia With Failed Remission
Acute Lymphoblastic Leukemia Not Having Achieved Remission
Acute Lymphoblastic Leukemia, Pediatric
Acute Lymphoblastic Leukemia, Adult
Acute Lymphoblastic Leukemia, in Relapse

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 18, 2023Actual

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Mar 3, 2023

First Submission Date that Met QC Criteria

Mar 29, 2023

First Posted Date

Apr 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2024

Last Update Posted Date

May 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Conditions Module

Conditions

Acute Lymphoblastic Leukemia With Failed Remission
Acute Lymphoblastic Leukemia Not Having Achieved Remission
Acute Lymphoblastic Leukemia, Pediatric
Acute Lymphoblastic Leukemia, Adult
Acute Lymphoblastic Leukemia, in Relapse

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)
Written informed consent

Exclusion Criteria:

Patients receiving an alternate CD19-directed CAR T-cell product on a clinical trial
Any reason that in the opinion of the investigator, patients won't be able to adhere to the protocol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

The study population is paediatric and young adult patients aged 25 or younger who have relapsed/refractory B-cell acute lymphoblastic leukaemia.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
CARPERS Trial Manager	Contact	442031084189		ctc.carpers@ucl.ac.uk

Overall Officials

Name	Affiliation	Role
Persis Amrolia, BSc,MBBS,PhD	UCL Institute of Child Health	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Great Ormond Street Hospital	Recruiting	London			United Kingdom

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases