Clinical Trials /

Study of GDX012 in Patients With MRD Positive AML

NCT05001451

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of GDX012 in Patients With MRD Positive AML
  • 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

Clinical Trial IDs

  • ORG STUDY ID: GDX012U-001
  • NCT ID: NCT05001451

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
GDX012 Suspension for IV InfusionGDX012 Suspension for IV Infusion

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
GDX012 Suspension for IV InfusionExperimentalAllogeneic cell therapy that is enriched for Vδ1+ γδ T cells
  • GDX012 Suspension for IV Infusion

Eligibility Criteria

        Inclusion Criteria:

          -  ≥ 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

          -  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

        Exclusion Criteria:

          -  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

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of treatment emergent adverse events (AEs) and serious adverse events (SAEs)
Time Frame:Up to 100 days
Safety Issue:
Description:AEs and SAEs occurring following administration of GDX012

Secondary Outcome Measures

Measure:Evaluate the antileukemic activity of GDX012
Time Frame:Up to 1 year
Safety Issue:
Description:Minimal residual disease (MRD) assessed by flow cytometry
Measure:Evaluate the antileukemic activity of GDX012
Time Frame:Up to 1 year
Safety Issue:
Description:Incidence of patients converting from MRD positive to MRD negative
Measure:Evaluate the antileukemic activity of GDX012
Time Frame:Up to 1 year
Safety Issue:
Description:Progression-free survival (PFS) and overall survival (OS)

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:GammaDelta Therapeutics Limited

Trial Keywords

  • AML
  • MRD
  • gamma delta T-cells
  • allogeneic
  • cell therapy

Last Updated

August 12, 2021