Acute Myeloid LeukemiaPhase 1NCT05001451
Study of GDX012 in Patients With MRD Positive AML
A Phase 1 study testing GDX012 Suspension for IV Infusion in people with Acute Myeloid Leukemia, run by GammaDelta Therapeutics Limited at 1 site in United States.
Trial summary
The purpose of this first-in-human study is to assess the safety, tolerability, antileukemic activity and maximum tolerated dose (MTD) of GDX012 in AML patients who are MRD positive by multiparametric flow cytometry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- GDX012 Suspension for IV Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2021to 3 Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- Weight ≥ 40 kg
- Anticipated life expectancy > 3 months prior to lymphodepletion
- Karnofsky Performance Score ≥ 70%
- Histologically confirmed diagnosis of AML
- In complete response (CR) (including CRi/CRp); patients in first, second or subsequent CR (including CRi/CRp) are permitted
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- MRD detected in bone marrow by MFC
- Negative pregnancy test (females of childbearing potential only)
- Agree to use effective birth control
- Left ventricular ejection fraction (LVEF) ≥ 50%
- Platelet Count ≥ 20 x 109/L
- Prothrombin Time or INR ≤ 1.5 x ULN (unless receiving therapeutic anticoagulation)
- Partial Thromboplastin Time ≤ 1.5 x ULN (unless receiving therapeutic anticoagulation)
- Hemoglobin ≥ 8.0 g/dL
- Creatinine Clearance ≥ 40mL/min
- Serum Total Bilirubin ≤ 1.5 x ULN (unless documented Gilbert's Syndrome with Direct Bilirubin < 35% of Total Bilirubin)
- ALT ≤ 2.5 x ULN
Who cannot join
- Cytotoxic chemotherapy within 3 weeks
- Immune therapy within 4 weeks
- Immunosuppressive therapy within 2 weeks (with exceptions)
- Investigational treatment or interventional clinical trial within 4 weeks or 5 half-lives (if known), whichever is longer
- Major surgery within 4 weeks and/or not fully recovered from surgery-related toxicities
- Known hypersensitivity to chemotherapy, other agents, or excipients used in this study
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- Female patient that is pregnant or lactating/breastfeeding
- Ongoing toxicity from prior anti-cancer therapy that have not recovered to ≤ Grade 1 (with exceptions)
- History of chronic or recurrent autoimmune or immune-mediated disease requiring steroids or other immunosuppressive treatments (including anti-tumor necrosis factor agents)
- Active CNS involvement (i.e. leukemic infiltration)
- Any other malignancy that requires active therapy
- Uncontrolled intercurrent illness (i.e. acute coronary syndrome in the last 6 months)
- Active infection with HIV, Hepatitis B or Hepatitis C
- NOTE: other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open Label, Dose Escalation, and Dose Expansion Study to Assess the Safety, Tolerability, and Preliminary Antileukemic Activity of GDX012 in Patients With Minimal Residual Disease (MRD) Positive Acute Myeloid Leukemia
The purpose of this first-in-human study is to assess the safety, tolerability, antileukemic activity and maximum tolerated dose (MTD) of GDX012 in AML patients who are MRD positive by multiparametric flow cytometry.
The study will consist of a dose escalation stage to evaluate various doses of GDX012 after a lymphodepletion regimen comprising fludarabine and cyclophosphamide. Following determination of the MTD of GDX012, the study will expand at the MTD. Patients will be followed up for 12 months, after receiving GDX012.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- GDX012 Suspension for IV Infusion
- Keywords
- AML, MRD, gamma delta T-cells, allogeneic, cell therapy
- 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.
GDX012 Suspension for IV InfusionBiological
Biological: GDX012 Suspension for IV Infusion (single dose) following chemotherapy for lymphodepletion.
Drug: Fludarabine; chemotherapy for lymphodepletion
Drug: Cyclophosphamide; chemotherapy for lymphodepletion
| Study group | Role | What they receive |
|---|---|---|
| GDX012 Suspension for IV Infusion | Experimental | Allogeneic cell therapy that is enriched for Vδ1+ γδ T cells Receives: Biological: GDX012 Suspension for IV Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (AEs) and serious adverse events (SAEs)
AEs and SAEs occurring following administration of GDX012
Measured: Up to 100 days
Incidence of treatment emergent clinically significant abnormal laboratory assessments
Standard clinical laboratory assessments for organ function (i.e. heart, kidney, liver)
Measured: Up to 100 days
Incidence of dose limiting toxicities (DLTs)
DLTs occurring following administration of GDX012, measured using CTCAE 5.0 criteria
Measured: Up to 100 days
Establish the maximum tolerated dose (MTD) of GDX012
Measured: Up to 100 days
Secondary outcomes (3)
Evaluate the antileukemic activity of GDX012
Minimal residual disease (MRD) assessed by flow cytometry
Measured: Up to 1 year
Evaluate the antileukemic activity of GDX012
Incidence of patients converting from MRD positive to MRD negative
Measured: Up to 1 year
Evaluate the antileukemic activity of GDX012
Progression-free survival (PFS) and overall survival (OS)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start13 Aug 2021
- Primary completion3 Jun 2022
- Study completion3 Jun 2022
Why it stopped: This was a business decision to discontinue this clinical trial. The decision is not related to the safety of the investigational product, GDX012.
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
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- GammaDelta Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Koslowski, MD, Study director, GammaDelta Therapeutics Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001451
- Sponsor's protocol ID
- GDX012U-001
- Status last verified
- Jul 2022
- First submitted
- 5 Jul 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Dose Escalation, and Dose Expansion Study to Assess the Safety, Tolerability, and Preliminary Antileukemic Activity of GDX012 in Patients With Minimal Residual Disease (MRD) Positive Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05001451
- Acronym / sponsor ID
- GDX012U-001
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, MRD, gamma delta T-cells, allogeneic, cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This was a business decision to discontinue this clinical trial. The decision is not related to the safety of the investigational product, GDX012.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- GammaDelta Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 12 Aug 2021 (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.
The purpose of this first-in-human study is to assess the safety, tolerability, antileukemic activity and maximum tolerated dose (MTD) of GDX012 in AML patients who are MRD positive by multiparametric flow cytometry.
The study will consist of a dose escalation stage to evaluate various doses of GDX012 after a lymphodepletion regimen comprising fludarabine and cyclophosphamide. Following determination of the MTD of GDX012, the study will expand at the MTD. Patients will be followed up for 12 months, after receiving GDX012.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GDX012 Suspension for IV Infusion | Experimental | Biological: GDX012 Suspension for IV InfusionAllogeneic cell therapy that is enriched for Vδ1+ γδ T cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- ≥ 18 years old
- Weight ≥ 40 kg
- Anticipated life expectancy > 3 months prior to lymphodepletion
- Karnofsky Performance Score ≥ 70%
- Histologically confirmed diagnosis of AML
Key exclusion criteria (14 listed)
- Cytotoxic chemotherapy within 3 weeks
- Immune therapy within 4 weeks
- Immunosuppressive therapy within 2 weeks (with exceptions)
- Investigational treatment or interventional clinical trial within 4 weeks or 5 half-lives (if known), whichever is longer
- Major surgery within 4 weeks and/or not fully recovered from surgery-related toxicities
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 |
|---|---|---|
| GDX012 Suspension for IV InfusionBiological: GDX012 Suspension for IV Infusion (single dose) following chemotherapy for lymphodepletion. Drug: Fludarabine; chemotherapy for lymphodepletion Drug: Cyclophosphamide; chemotherapy for lymphodepletion | Biological | GDX012 Suspension for IV Infusion |
Primary outcome
Incidence of treatment emergent adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 100 days
AEs and SAEs occurring following administration of GDX012
Incidence of treatment emergent clinically significant abnormal laboratory assessments
Time frame: Up to 100 days
Standard clinical laboratory assessments for organ function (i.e. heart, kidney, liver)
Incidence of dose limiting toxicities (DLTs)
Time frame: Up to 100 days
DLTs occurring following administration of GDX012, measured using CTCAE 5.0 criteria
Establish the maximum tolerated dose (MTD) of GDX012
Time frame: Up to 100 days
3 secondary outcomes
Evaluate the antileukemic activity of GDX012
Time frame: Up to 1 year
Evaluate the antileukemic activity of GDX012
Time frame: Up to 1 year
Evaluate the antileukemic activity of GDX012
Time frame: Up to 1 year
Results and safety
The study was stopped early (reason given: This was a business decision to discontinue this clinical trial. The decision is not related to the safety of the investigational product, GDX012.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Michael Koslowski, MD study director
GammaDelta Therapeutics Limited
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 GDX012 Suspension for IV Infusion in people with Acute Myeloid Leukemia, run by GammaDelta Therapeutics Limited at 1 site in United States.
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 17 inclusion and 14 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: stopped early, as of the sponsor's last update on 20 Jul 2022. 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 United States. 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 was stopped early (reason given: This was a business decision to discontinue this clinical trial. The decision is not related to the safety of the investigational product, GDX012.). Results are not available in the source record.
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) and serious adverse events (SAEs) (time frame: Up to 100 days). The study lists 4 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 20 Jul 2022.