Anti-CCR9 CAR T Cells for T Cell Leukaemia/Lymphoma (FRACTALL)

University College London (UCL)

Status and phase: Enrolling; Phase 1

Conditions: T Cell Acute Lymphoblastic Leukemia; T Cell Lymphoblastic Lymphoma

Treatments: Biological: CARCCR9 T cells

Study type: Interventional

Funder types: Other

Identifiers

NCT07300683

2022-003497-23 (EudraCT Number)

ISRCTN15341827 (Other Identifier)

UCL/150854

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Autologous anti-CCR9 CAR T cells

Experimental group

Description:

Patients will receive autologous anti-CCR9 CAR T cells intravenously.

Treatment:

Biological: CARCCR9 T cells