Acute Myeloid LeukemiaPhase 1NCT03790072
Ex-vivo Expanded γδ T-lymphocytes (OmnImmune®) in Patients With Acute Myeloid Leukaemia (AML)
A Phase 1 study testing OmnImmune® in people with Acute Myeloid Leukemia, run by TC Biopharm at 1 site in Czechia.
Trial summary
This study investigates the potential curative properties of gamma delta T-cells obtained from a blood-related donor of an AML patient. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- OmnImmune®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCzechia
- Study dates
- 27 Nov 2018to 26 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- Active autoimmune disease or GvHD
- Pregnant or breastfeeding
- Patient of fertile age not using two-barrier method of birth control.
Trial locations and contacts
1 site in 1 country.
About this study
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
This study investigates the potential curative properties of gamma delta T-cells obtained from a blood-related donor of an AML patient.
Read the 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- OmnImmune®
- Keywords
- Gamma Delta T Lymphocytes
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmnImmune®Biological
Also called fludarabine, cyclophosphamide
infusion of OmnImmune® (expanded gamma delta T lymphocytes)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: OmnImmune® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 28 after completion of treatment
Secondary outcomes (3)
Number of patients reaching Complete Remission (CR) [Efficacy]
Efficacy of OmnImmune® assessed by number of patients reaching Complete Remission (CR)
Measured: 24 months post-treatment
Overall Survival (OS) [Efficacy]
Efficacy of OmnImmune® assessed by overall survival (OS) measured in months
Measured: 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.
Measured: 24 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start27 Nov 2018
- Primary completion26 Mar 2021
- Study completion26 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Biopharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790072
- Sponsor's protocol ID
- TCB-202-001
- Other IDs
- 2018-000409-22, 2018
- Status last verified
- Mar 2021
- First submitted
- 12 Dec 2018
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03790072
- Acronym / sponsor ID
- TCB-202-001
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Gamma Delta T Lymphocytes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- TC BiopharmIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 screened for comorbidities. Suitably matched or haploidentical family donors will be selected according to protocol specified criteria and institutional guidelines of participating site.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation, 3 cohorts, x10 dose increments between cohorts (10^6, 10^7, 10^8 of cells per kg of body weight).
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Biological: OmnImmune®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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmnImmune®Also: fludarabine, cyclophosphamideinfusion of OmnImmune® (expanded gamma delta T lymphocytes) | Biological | Treatment Arm |
Primary outcome
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
3 secondary outcomes
Number of patients reaching Complete Remission (CR) [Efficacy]
Time frame: 24 months post-treatment
Overall Survival (OS) [Efficacy]
Time frame: 24 months post-treatment
Quality of Life (QoL)
Time frame: 24 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OmnImmune® in people with Acute Myeloid Leukemia, run by TC Biopharm at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (AEs) [Safety] (time frame: Day 28 after completion of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.