Anti-CCR9 CAR T Cells for T Cell Leukaemia/Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity College, London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
CARCCR9 T cells
Biological/VaccineAnti-CCR9 CAR T cells
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Autologous anti-CCR9 CAR T cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
2 years2
Incidence of treatment-related adverse events (safety and tolerability)
Incidence of grade 3-5 toxicity causally related to the ATIMP.
Time frame
From CAR T cells infusion until 28 days post infusionSecondary outcomes
1
Persistence of CARCCR9 T cells
Persistence of circulating CARCCR9 T cells in peripheral blood
Time frame
From CAR T cells infusion until 2 years post infusion2
Expansion of CARCCR9 T cells
Frequency of circulating CARCCR9 T cells in peripheral blood
Time frame
From CAR T cells infusion until 2 years post infusion3
Potential efficacy of CARCCR9 T cells
Proportion of responders
Time frame
At 1 and 2 years post CAR T cells infusion4
Potential efficacy of CARCCR9 T cells
Depth of response
Time frame
At 1 and 2 years post CAR T cells infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University College, London
Lead sponsor
Great Ormond Street Hospital Charity
Collaborator
Medical Research Council
Collaborator
Source ClinicalTrials.gov