Study of GDX012 in Patients With MRD Positive AML
Recruiting at1 trial location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: GammaDelta Therapeutics Limited
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
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.
Research Team
MK
Michael Koslowski, MD
Principal Investigator
GammaDelta Therapeutics Limited
Eligibility Criteria
Inclusion Criteria
≥ 18 years old
Weight ≥ 40 kg
Anticipated life expectancy > 3 months prior to lymphodepletion
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Treatment Details
Interventions
- GDX012 (CAR T-cell Therapy)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: GDX012 Suspension for IV InfusionExperimental Treatment1 Intervention
Allogeneic cell therapy that is enriched for Vδ1+ γδ T cells
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Who Is Running the Clinical Trial?
GammaDelta Therapeutics Limited
Lead Sponsor
Trials
1
Recruited
3+
Founded
2016
Headquarters
London, UK
Known For
γδ T Cell Therapies