Study of GDX012 in Patients With MRD Positive AML
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Biological: GDX012 Suspension for IV Infusion
- Registration Number
- NCT05001451
- Lead Sponsor
- GammaDelta Therapeutics Limited
- Brief 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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- ≥ 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description GDX012 Suspension for IV Infusion GDX012 Suspension for IV Infusion Allogeneic cell therapy that is enriched for Vδ1+ γδ T cells
- Primary Outcome Measures
Name Time Method Establish the maximum tolerated dose (MTD) of GDX012 Up to 100 days Incidence of treatment emergent adverse events (AEs) and serious adverse events (SAEs) Up to 100 days AEs and SAEs occurring following administration of GDX012
Incidence of treatment emergent clinically significant abnormal laboratory assessments Up to 100 days Standard clinical laboratory assessments for organ function (i.e. heart, kidney, liver)
Incidence of dose limiting toxicities (DLTs) Up to 100 days DLTs occurring following administration of GDX012, measured using CTCAE 5.0 criteria
- Secondary Outcome Measures
Name Time Method Evaluate the antileukemic activity of GDX012 Up to 1 year Progression-free survival (PFS) and overall survival (OS)
Trial Locations
- Locations (1)
City of Hope
🇺🇸Duarte, California, United States