Ex-vivo Expanded γδ T-lymphocytes (OmnImmune®) in Patients With Acute Myeloid Leukaemia (AML)

This is an open-label, safety and efficacy, escalating dose, single arm study on 9 adult subjects (3 cohorts) and 3+3 design will be used. HLA typed patients and potential blood-related donors will be screened for comorbidities. Suitably matched or haploidentical family donors will be selected according to protocol specified criteria and institutional guidelines of participating site.

Inclusion criteria

• History of acute myeloid leukaemia (initially diagnosed by presence of 20% or more blast cells with myeloid or monocytic differentiation confirmed by flow cytometry in peripheral blood or bone marrow)
• Relapsed or refractory AML

• AML relapse after intensive chemotherapy OR
• AML relapse after allogeneic HCT OR
• AML progression on low intensity therapy (low dose cytarabine, 5-azacytidine or decitabine) OR
• No response to at least 4 cycles of low intensity therapy
• AML refractory to 2 cycles of induction chemotherapy
• Presence of > 5% of blasts in bone marrow or peripheral blood smear
• Patient not eligible for or does not consent to high dose salvage chemotherapy and/or allogeneic Haematopoietic Cell Transplantation (HCT)
• Considered suitable for lymphodepleting chemotherapy
• Age 18 years up to the age of 70 (≤ 70)
• Life expectancy of at least 3 months
• Karnofsky performance status ≥ 50%
• Available related HLA-haploidentical or HLA-matched donor
• Ability to be off systemic prednisone and other immunosuppressive drugs for at least 3 days prior to γδ T cells product infusion. Maintenance replacement steroid is allowed.
• Patient able to understand and sign written informed consent

Exclusion criteria

• Uncontrolled infections
• Renal insufficiency: creatinine > 180 μmol/L or on dialysis
• Heart failure: EF < 40%
• Respiratory insufficiency: oxygen therapy required at inclusion in the study
• Significant liver impairment: bilirubin > 50 μmol/L, AST or ALT > 4 times normal upper limit
• Treatment with bisphosphonates (2 months before start)
• Active autoimmune disease or GvHD
• Pregnant or breastfeeding
• Patient of fertile age not using two-barrier method of birth control.