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Phase I study of transfer of effector memory T cells (Tem) following allogeneic stem cell transplantation.

Study ID: 41262
Short Title: ToTem
Trust Name: UHS
Recruitment Site: Southampton General Hospital
Disease Area: Haematology
Phase: N/A
Expected End Date: 01/10/2024
Postcode: SO16 6YD
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Patient: - Severe aplastic anaemia or - Primary immune deficiency or - Haematological cancer which can be ONE OF the following: o Non-Hodgkin’s lymphoma (NHL) in CR or PR; o Hodgkin’s lymphoma (HL) in CR or PR; o Chronic (Pro-)lymphocytic leukaemia (CLL or PLL) in CR or PR o Plasma cell myeloma (PCM) in CR, VGPR or PR; o Acute myeloid leukaemia (AML) in CR; o Acute lymphoblastic leukaemia (ALL) in CR; o Myelodysplastic syndrome (MDS) < 10 % blasts in bone marrow; o Chronic myelomonocytic leukaemia (CMML) < 10% blasts in bone marrow - Have undergone disease reassessment within 8 weeks prior to registration - Suitable for HLA-identical sibling transplant using a standard alemtuzumab-based conditioning regimen with calcineurin-inhibitor based immunoprophylaxis - Aged > = 16 years, < 70 years - Written informed consent Donor: - Aged > = 16 years - HLA-identical sibling - Have met transplant centre criteria regarding suitability for cell therapy donation - Negative for HIV 1 and 2, hepatitis B, hepatitis C, HTLV-1 and 2, syphilis serology - Written informed consent

Patient: - Women who are pregnant or breast feeding - Life expectancy of < 8 weeks - Currently taking part in any other interventional clinical research study (involving any IMP, ATIMP or cellular therapy) - Proposed use of any other method of GvVHD prophylaxis other than alemtuzumab and calcineurin inhibitor - Organ dysfunction: o LVEF< 45% o Glomerular filtration rate (corrected) < 50ml/min o Bilirubin > 50µmol/l o AST or ALT > 2.5 x ULN (NB: If both are performed then both must be < = 2.5 x ULN) Trial Treatment Exclusion Criteria (patient eligibility check 2 days prior to CD62L- Tem Infusion) - Prior or active acute pattern GvHD of any grade - Relapse or progression - Primary or secondary graft failure - Has received other cellular therapies Donor: - Pregnant/lactating women

Healthy bone marrow produces blood cells, including infection-fighting immune cells. These blood cells originate from stem cells. In cancer, the bone marrow can no longer function properly. To restore healthy blood cell production and to fight the cancer, some patients are given healthy stem cells from a donor’s bone marrow. Although this can cure many patients, it can have serious side effects, including ‘graft versus host disease’ (GvHD). This happens because the bone marrow contains donor immune cells (the ‘graft’) that see the patient’s healthy cells (the ‘host’) as foreign and attacks them. It mainly affects the tissues of the skin, the liver and the gut and can be life threatening. Drugs that prevent GvHD by suppressing the donor’s immune cells in the patient’s body renders the immune system weak and unable to fight infections. These infections are sometimes very severe and can lead to patients dying. This trial aims to find out if giving patients additional infection fighting immune cells from the donor (Tem cells) will reduce their chance of getting an infection without causing GvHD. Patients will receive additional donor immune cells about one month after the transplant. They will also receive the standard GvHD prevention treatment. Different doses of the donor immune cells will be given to individual patients to work out which dose is best. All patients will be closely monitored for signs of GvHD or infection. They will also have blood tests to determine how well and quickly their immune systems recover. Patients will be followed up for 12 months post treatment. The study will recruit a maximum of 18 patients. The study will be conducted at NHS hospitals and is expected to last 22 months.

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