AUTO4-TL1

 Non-Hodgkin lymphoma / Posted 12 months ago

AUTO4-TL1: A trial of CAR T-cell for people with T cell lymphoma

Researchers are looking at new ways to help people with relapsed or refractory T cell lymphoma. In this trial, they are looking at a new treatment called CAR T-cell.
CAR T-cell treatment uses the T cells from your immune system. These cells are good at helping us fight infections, but they aren’t so good at recognising lymphoma cells.
With this treatment, doctors collect your T cells and change them in the laboratory so that they recognise and attack the lymphoma cells that have the TRBC1 protein. These altered T cells are called AUTO4.
This trial is in 2 parts. In part 1 doctors are looking for the best dose of AUTO4. This part is called dose escalation. In part 2, they will collect information about how well the treatment works. This is the dose expansion part.
  • Inclusion Criteria :
    • you have T cell non Hodgkin lymphoma (peripheral T cell lymphoma,
    • anaplastic large cell lymphoma or angioimmunoblastic T cell lymphoma)
    • your T cell lymphoma has TRBC1 proteins on its surface (TRBC1 positive)
    • your lymphoma has come back or treatment has stopped working (relapsed or refractory)
    • you have had at least one treatment for T cell lymphoma
    • you have at least 1 area of lymphoma that doctors can see and measure on a scan
    • you are able to have your T cells collected
    • you have satisfactory blood tests results
    • your kidneys, liver, heart and lungs are working well
    • you are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
    • you are at least 18 years old
    • you are willing to use reliable contraception during treatment and for up to a year afterwards if there is any possibility that you or your partner could become pregnant
  • Exclusion Criteria :
    • have T cell leukaemia
    • have lymphoma spread in your brain or the spinal cord
    • have had gene therapy
    • have had a stem cell transplant from a donor (allogeneic stem cell transplant )
    • have had treatment with drugs that target the programmed cell death 1 protein (PD1), the PDL1 or the CTLA-4 protein (your doctor can tell you more about this)
    • have had chemotherapy in the past 2 weeks
    • have had rituximab or any other similar drug in the last 3 months
    • are having radiotherapy or a targeted cancer drug (biological therapy)
    • have had another cancer in the last 2 years apart from non melanoma skin cancer or carcinoma in situ of the breast or prostate that has been successfully treated
    • are having an investigational treatment
    • have problems with your brain, spinal cord and nerves such as epilepsy
    • have had a stroke in the past 3 months
    • have heart problems such as angina that isn’t stable, an abnormal heart rhythm, high blood pressure that isn’t controlled or you have had a heart attack in the last year
    • have had problems with blood clots in your legs in the past 3 months and you are having treatment for this
    • have a bleed in your tummy (abdomen)
    • have had major surgery in the last 3 months
    • have an infection that needs treatment
    • have taken steroids within 3 days of having CAR T-cell treatment
    • have HIV
    • have hepatitis B or hepatitis C
    • have an autoimmune disease and you need to take drugs that damp down
    • your immune system (immunosuppressants)
    • have any other serious medical condition or mental health problem that the
    • trial team think could affect you taking part
    • have had a live vaccine in the last month
    • are pregnant or breastfeeding
  • Study start date : 31/08/2018
  • Study end date : 31/07/2021
  • Wales-Based Study Contact : please speak to your clinician
  • Principal Investigator : Dr Kate Cwynarski

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