Trial Search Results

Study of GDX012 in Patients With MRD Positive AML

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

GammaDelta Therapeutics Limited

Stanford Investigator(s):

Intervention(s):

  • Biological: GDX012 Suspension for IV Infusion

Phase:

Phase 1

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nancy Sweeters
+1 650-721-4074
Not Recruiting