Status:
COMPLETED
Ex-vivo Expanded γδ T-lymphocytes (OmnImmune®) in Patients With Acute Myeloid Leukaemia (AML)
Lead Sponsor:
TC Biopharm
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This study investigates the potential curative properties of gamma delta T-cells obtained from a blood-related donor of an AML patient.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03790072
Start Date
November 27 2018
End Date
March 26 2021
Last Update
March 30 2021
Active Locations (1)
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1
UHKT (Ustav hematologie a krevni transfuze)
Prague, Czechia, 128 20