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.
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
Interventions
Drug | Synonyms | Arms |
---|
GDX012 Suspension for IV Infusion | | GDX012 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
Name | Type | Description | Interventions |
---|
GDX012 Suspension for IV Infusion | Experimental | Allogeneic 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