Study of GDX012 in Patients With MRD Positive AML

NCT05001451 | Terminated Phase 1 FDA Drug

• 1 other identifier: GDX012U-001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Incidence of treatment emergent adverse events (AEs) and serious adverse events (SAEs)

  AEs and SAEs occurring following administration of GDX012

  Up to 100 days

• Incidence of treatment emergent clinically significant abnormal laboratory assessments

  Standard clinical laboratory assessments for organ function (i.e. heart, kidney, liver)

  Up to 100 days

• Incidence of dose limiting toxicities (DLTs)

  DLTs occurring following administration of GDX012, measured using CTCAE 5.0 criteria

  Up to 100 days

• Establish the maximum tolerated dose (MTD) of GDX012

  Up to 100 days

Secondary Outcomes (3)

• Evaluate the antileukemic activity of GDX012

  Up to 1 year

• Evaluate the antileukemic activity of GDX012

  Up to 1 year

• Evaluate the antileukemic activity of GDX012

  Up to 1 year

Study Arms (1)

GDX012 Suspension for IV Infusion

EXPERIMENTAL

Allogeneic cell therapy that is enriched for Vδ1+ γδ T cells

Biological: GDX012 Suspension for IV Infusion

Interventions

GDX012 Suspension for IV Infusion BIOLOGICAL

Biological: GDX012 Suspension for IV Infusion (single dose) following chemotherapy for lymphodepletion. Drug: Fludarabine; chemotherapy for lymphodepletion Drug: Cyclophosphamide; chemotherapy for lymphodepletion

GDX012 Suspension for IV Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GammaDelta Therapeutics Limited: lead

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Infusions, Intravenous

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Officials

• Michael Koslowski, MD

  GammaDelta Therapeutics Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: August 12, 2021
• Study Start: August 13, 2021
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)