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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
Sponsor:
Information provided by (Responsible Party):
TC Biopharm

Brief Summary:
This study investigates the potential curative properties of gamma delta T-cells obtained from a blood-related donor of an AML patient.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Biological: OmnImmune® Phase 1

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 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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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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.

Biological: OmnImmune®
infusion of OmnImmune® (expanded gamma delta T lymphocytes)
Other Names:
  • fludarabine
  • cyclophosphamide




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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)

  2. Overall Survival (OS) [Efficacy] [ Time Frame: 24 months post-treatment ]
    Efficacy of OmnImmune® assessed by overall survival (OS) measured in months

  3. 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.


Other Outcome Measures:
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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)
  2. Relapsed or refractory AML

    1. AML relapse after intensive chemotherapy OR
    2. AML relapse after allogeneic HCT OR
    3. AML progression on low intensity therapy (low dose cytarabine, 5-azacytidine or decitabine) OR
    4. No response to at least 4 cycles of low intensity therapy
    5. AML refractory to 2 cycles of induction chemotherapy
  3. Presence of > 5% of blasts in bone marrow or peripheral blood smear
  4. Patient not eligible for or does not consent to high dose salvage chemotherapy and/or allogeneic Haematopoietic Cell Transplantation (HCT)
  5. Considered suitable for lymphodepleting chemotherapy
  6. Age 18 years up to the age of 70 (≤ 70)
  7. Life expectancy of at least 3 months
  8. Karnofsky performance status ≥ 50%
  9. Available related HLA-haploidentical or HLA-matched donor
  10. 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.
  11. Patient able to understand and sign written informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Locations
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Czechia
UHKT (Ustav hematologie a krevni transfuze)
Praha, Czechia, 128 20
Sponsors and Collaborators
TC Biopharm
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Responsible Party: TC Biopharm
ClinicalTrials.gov Identifier: NCT03790072    
Other Study ID Numbers: TCB-202-001
2018-000409-22 ( EudraCT Number )
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TC Biopharm:
Gamma Delta T Lymphocytes
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists