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Recruiting NCT07300683

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

Phase I Interventional T Cell Acute Lymphoblastic Leukemia T Cell Lymphoblastic Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CARCCR9 T cells.
Who it may be relevant to
Registry conditions: T Cell Acute Lymphoblastic Leukemia, T Cell Lymphoblastic Lymphoma. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Fratricide-Resistant Autologous Chimeric Antigen Receptor T Cells Targeting CCR9 for the Treatment of T Cell Acute Lymphoblastic Leukaemia/ Lymphoma

Overview

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.

Interventions

  • Biological CARCCR9 T cells
    Anti-CCR9 CAR T cells

Primary outcome measures

  • Feasibility of generation of CARCCR9 T cells as evaluated by the number of therapeutic products generated. [Time frame: 2 years]
  • Incidence of treatment-related adverse events (safety and tolerability) [Time frame: From CAR T cells infusion until 28 days post infusion]
Secondary outcome measures (7)
  • Persistence of CARCCR9 T cells [Time frame: From CAR T cells infusion until 2 years post infusion]
  • Expansion of CARCCR9 T cells [Time frame: From CAR T cells infusion until 2 years post infusion]
  • Potential efficacy of CARCCR9 T cells [Time frame: At 1 and 2 years post CAR T cells infusion]
  • Potential efficacy of CARCCR9 T cells [Time frame: At 1 and 2 years post CAR T cells infusion]
  • Time to disease progression [Time frame: From CAR T cells infusion (Day 0) until the date of first documented progression, assessed up to 15 years post CAR T cells infusion.]
  • Event free survival [Time frame: From CAR T cells infusion (Day 0) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 years post CAR T cells infusion.]
  • Overall survival [Time frame: From CAR T cells infusion (Day 0) until the date of death from any cause, assessed up to 15 years post CAR T cells infusion.]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • University College London Hospitals — London

Identifiers

NCT: NCT07300683 · UCL/150854 · 2022-003497-23 · ISRCTN15341827

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗