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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000409-22 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OmnImmune® | Biological | infusion of OmnImmune® (expanded gamma delta T lymphocytes) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Day 28 after completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients reaching Complete Remission (CR) [Efficacy] | Efficacy of OmnImmune® assessed by number of patients reaching Complete Remission (CR) | 24 months post-treatment |
| Overall Survival (OS) [Efficacy] |
| Measure | Description | Time Frame |
|---|---|---|
| Persistence of γδ T cells | 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 | Before treatment and up to 24 months after treatment |
| Phenotype of γδ T cells |
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
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHKT (Ustav hematologie a krevni transfuze) | Prague | 128 20 | Czechia |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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Dose escalation, 3 cohorts, x10 dose increments between cohorts (10^6, 10^7, 10^8 of cells per kg of body weight).
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Efficacy of OmnImmune® assessed by overall survival (OS) measured in months
| 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. | 24 months post-treatment |
Phenotype of γδ T cells assessed by flow cytometry assay in peripheral blood and bone marrow from dosed patients |
| Before treatment and up to 24 months after treatment |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |