Anti-CCR9 CAR T Cells for T Cell Leukaemia/Lymphoma | NCT07300683

Studies
Anti-CCR9 CAR T Cells for T Cell Leukaemia/Lymphoma

NCT07300683

Sponsor

University College, London

Status

Recruiting

Last Update Posted

Dec 24, 2025Actual

Enrollment

24Estimated

Phase

Phase 1

Conditions

T Cell Acute Lymphoblastic Leukemia
T Cell Lymphoblastic Lymphoma

Interventions

CARCCR9 T cells

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2022-003497-23	EudraCT Number
ISRCTN15341827	Other Identifier	ISRCTN

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 11, 2025Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2042Estimated

First Submitted Date

Sep 15, 2025

First Submission Date that Met QC Criteria

Dec 17, 2025

First Posted Date

Dec 24, 2025Actual

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

Dec 17, 2025

Last Update Posted Date

Dec 24, 2025Actual

Name	Class
Great Ormond Street Hospital Charity	UNKNOWN
Medical Research Council	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The goal of this clinical trial is to learn if anti-CCR9 CAR T cells (which will be made using the patient's own blood cells) are safe and which dose should be used in children and adults with T cell leukaemia and lymphoma.

Participants will:

have T cells collected from their blood and these T cells will be used to make the CAR-T cells in a specialized laboratory.
be admitted at the hospital a week before the CAR T cells infusion to receive a short course of chemotherapy drugs which prepare the body to receive the CAR T cells.
be given the CAR T cells into their vein.
stay in the hospital for a minimum of 2 weeks to be closely monitored
following discharge, participants will come to the clinic for check-ups (approximately 12 visits in the first two years)
during screening, treatment and follow up visits, participants will have physical examination, collection of blood samples and bone marrow biopsies and/or imaging tests (CT/PET-CT scans) depending on their type of T-cell cancer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Autologous anti-CCR9 CAR T cells	Experimental	Patients will receive autologous anti-CCR9 CAR T cells intravenously.	Biological: CARCCR9 T cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CARCCR9 T cells	Biological	Anti-CCR9 CAR T cells	Autologous anti-CCR9 CAR T cells

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of generation of CARCCR9 T cells as evaluated by the number of therapeutic products generated.	To determine the feasibility of semi-automated autologous CARCCR9 T cells manufacture in patients with r/r T-ALL/T-LBL, in the setting of a Phase I trial.	2 years
Incidence of treatment-related adverse events (safety and tolerability)	Incidence of grade 3-5 toxicity causally related to the ATIMP.	From CAR T cells infusion until 28 days post infusion

Secondary Outcomes

Measure	Description	Time Frame
Persistence of CARCCR9 T cells	Persistence of circulating CARCCR9 T cells in peripheral blood	From CAR T cells infusion until 2 years post infusion
Expansion of CARCCR9 T cells	Frequency of circulating CARCCR9 T cells in peripheral blood

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Relapsed or refractory T-ALL/T-LBL following at least one (≥18 years old) or two (<18 years old) standard prior lines of combination cytotoxic therapy
CCR9-positive disease as assessed by flow cytometry
T-LBL patients only: Patients must have measurable disease
Agreement to have a pregnancy test, use adequate contraception (if applicable)
Written informed consent

Key Exclusion Criteria:

ECOG performance score >2 (patients aged ≥10 years old) OR Lanksy score ≤50% (patients aged <10 years old)
Stem Cell Transplant patients only: active significant acute GvHD or moderate/severe chronic GvHD requiring immunosuppressive therapy and/or systemic steroids
Active CNS involvement of disease
Active hepatitis B, C or HIV infection
Oxygen saturation ≤90% on air
Bilirubin >3 x upper limit of normal
GFR <30 ml/min
Cardiac dysfunction
Patients receiving corticosteroids at a supraphysiological dose that cannot be discontinued
Known allergy to any component of the ATIMP
Any contraindications to lymphodepletion or to the use of cyclophosphamide or fludarabine as per local SmPC
Women who are pregnant or breastfeeding
Life expectancy <3 months
Fulminant or rapidly progressive disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
FRACTALL Trial Manager	Contact	+44 (0)20 76705748		ctc.fractall@ucl.ac.uk

Facility	Status	City	State	ZIP	Country	Contacts
University College London Hospitals	Recruiting	London			United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D054218	Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

This is a multi-centre, non-randomised, open-label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) for patients with high-risk, relapsed/refractory (r/r) T-ALL/T-LBL.

The trial will have 2 cohorts: Adult (≥18 years old) and Paediatric (<18 years old).