Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03836690
• Date of registration: 10/01/2019
• Prospective Registration: Yes
• Primary sponsor: University College, London
• Public title: Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation ToTem
• Scientific title: Phase I Study of Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation
• Date of first enrolment: October 21, 2019
• Target sample size: 18
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03836690
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Ron Chakraverty, Prof

• Name: Toyin Adedayo

Key inclusion & exclusion criteria

Patient Registration Inclusion Criteria:

- Severe aplastic anaemia or

- Primary immune deficiency or

- Haematological cancer which can be ONE OF the following:

- Non-Hodgkin's lymphoma (NHL) in CR or PR;

- Hodgkin's lymphoma (HL) in CR or PR;

- Chronic (Pro-)lymphocytic leukaemia (CLL or PLL) in CR or PR

- Plasma cell myeloma (PCM) in CR, VGPR or PR;

- Acute myeloid leukaemia (AML) in CR;

- Acute lymphoblastic leukaemia (ALL) in CR;

- Myelodysplastic syndrome (MDS) < 10 % blasts in bone marrow;

- Chronic myelomonocytic leukaemia (CMML) < 10% blasts in bone marrow

- 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

Patient Registration Exclusion Criteria:

- 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, ATMP or cellular therapy)

- Proposed use of any other method of GVHD prophylaxis other than alemtuzumab and
calcineurin inhibitor

- Organ dysfunction:

- LVEF<45%

- Creatinine >200 µmol/lglomerular filtration rate (corrected) <50ml/min

- Bilirubin > 50 µmol/l

- AST or ALT >3x 2.5 x ULN (NB: If both are performed then both must be =3 2.5 x
ULN)

Patient Trial Treatment Exclusion criteria:

- Prior or active acute pattern GvHD of any grade

- Relapse or progression

- Primary or secondary graft failure

- Has received other cellular therapies

Donor inclusion criteria:

- 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
(to be confirmed before both registration and before trial treatmentat time of or up
to 7 days following donation)

- Written informed consent

Donor exclusion criteria:

- Pregnant/lactating women



Age minimum: 16 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Leukemia

Graft Vs Host Disease

Myelodysplastic Syndromes

Primary Immune Deficiency

Severe Aplastic Anemia

Lymphoma

Myeloma

Intervention(s)

Biological: CD62L- Tem

Primary Outcome(s)

Occurrence of dose limiting toxicity (DLT) [Time Frame: up to 72 days after Tem infusion]

Secondary Outcome(s)

Non-relapse mortality [Time Frame: From date of patient registration up to 1 year post stem cell transplant]

Total Number of inpatient days [Time Frame: From date of infusion of Tem up to 1 year post stem cell transplant]

Incidence and severity of acute GvHD [Time Frame: From date of infusion of Tem until 100 days post stem cell transplant]

Overall survival [Time Frame: From date of patient registration up to 1 year post stem cell transplant]

Progression-free survival [Time Frame: From date of patient registration up to 1 year post stem cell transplant]

Incidence and severity of chronic GvHD [Time Frame: From date of infusion of Tem up to 1 year post stem cell transplant]

Incidence/type of infection requiring inpatient admission [Time Frame: From date of infusion of Tem up to 1 year post stem cell transplant]

Secondary ID(s)

MR/R025436/1

UCL/13/0372

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medical Research Council