Study of GDX012 in Patients With MRD Positive AML

GammaDelta Therapeutics

Status and phase

Terminated

Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Biological: GDX012 Suspension for IV Infusion

Study type

Interventional

Funder types

Industry

Identifiers

NCT05001451

GDX012U-001

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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