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
Qualifiers
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
Treatments tested in this trial
- CARCCR9 T cells
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
University College, London
Lead sponsor
Great Ormond Street Hospital Charity
Collaborator
Medical Research Council
Collaborator
Source ClinicalTrials.gov