Ex-vivo Expanded γδ T-lymphocytes (OmnImmune®) in Patients With Acute Myeloid Leukaemia (AML)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03790072|
Recruitment Status : Suspended (Suspended due to COVID-19 situation)
First Posted : December 31, 2018
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Biological: OmnImmune®||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Dose escalation, 3 cohorts, x10 dose increments between cohorts (10^6, 10^7, 10^8 of cells per kg of body weight).|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Ex-vivo Expanded Allogeneic γδ T-lymphocytes (OmnImmune®) in Patients With Active Relapsed or Refractory Acute Myeloid Leukaemia (AML) Who Are Not Eligible for or do Not Consent to High Dose Salvage Chemotherapy and/or Allogeneic Haematopoietic Cell Transplantation (HCT). A Dose Escalation, Open-label, Phase I Study|
|Actual Study Start Date :||November 27, 2018|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Treatment Arm
After inclusion, patients will receive conditioning chemotherapy consisting of non-investigational medicinal products (non-IMPs): fludarabine 25 mg/m2 from day -6 until day -2 (inclusive) and cyclophosphamide 500 mg/m2 on days -6 and -5.
Subsequently, patients in will be dosed with investigational medicinal product (IMP) OmnImmune® on day 0.
infusion of OmnImmune® (expanded gamma delta T lymphocytes)
- Incidence of Treatment-Emergent Adverse Events (AEs) [Safety] [ Time Frame: Day 28 after completion of treatment ]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
- Incidence of Dose-Limiting Toxicities (DLTs) [Tolerability] [ Time Frame: Day 28 after completion of treatment ]Tolerability of OmnImmune® assessed by incidence of dose-limiting toxicities (DLTs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
- Number of patients reaching Complete Remission (CR) [Efficacy] [ Time Frame: 24 months post-treatment ]Efficacy of OmnImmune® assessed by number of patients reaching Complete Remission (CR)
- Overall Survival (OS) [Efficacy] [ Time Frame: 24 months post-treatment ]Efficacy of OmnImmune® assessed by overall survival (OS) measured in months
- Quality of Life (QoL) [ Time Frame: 24 months post-treatment ]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.
- Persistence of γδ T cells [ Time Frame: Before treatment and up to 24 months after treatment ]Persistence of γδ T cells assessed by number and phenotype of γδ T cells using flow cytometry assay in peripheral blood and bone marrow from dosed patients
- Phenotype of γδ T cells [ Time Frame: Before treatment and up to 24 months after treatment ]Phenotype of γδ T cells assessed by flow cytometry assay in peripheral blood and bone marrow from dosed patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790072
|UHKT (Ustav hematologie a krevni transfuze)|
|Praha, Czechia, 128 20|