This study investigates the potential curative properties of gamma delta T-cells obtained from a blood-related donor of an AML patient.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
infusion of OmnImmune® (expanded gamma delta T lymphocytes)
UHKT (Ustav hematologie a krevni transfuze)
Prague, Czechia
Incidence of Treatment-Emergent Adverse Events (AEs) [Safety]
Safety of OmnImmune® assessed by incidence of treatment-emergent adverse events (AEs) per patient graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Day 28 after completion of treatment
Incidence of Dose-Limiting Toxicities (DLTs) [Tolerability]
Tolerability of OmnImmune® assessed by incidence of dose-limiting toxicities (DLTs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Day 28 after completion of treatment
Number of patients reaching Complete Remission (CR) [Efficacy]
Efficacy of OmnImmune® assessed by number of patients reaching Complete Remission (CR)
Time frame: 24 months post-treatment
Overall Survival (OS) [Efficacy]
Efficacy of OmnImmune® assessed by overall survival (OS) measured in months
Time frame: 24 months post-treatment
Quality of Life (QoL)
Quality of life determined by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 'C30' which comprises 30 items (i.e. single questions), 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time frame: 24 months post-treatment
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