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MacroGenics: Ph1 MGD006 Dual Affinity Re-Targeting (DART) for R/R AML (CP-MGD006-01) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if the study drug, MGD006, is safe and will work for people who have AML and/or MDS. We also want to know the best dose and side effects that may happen when taking the study drug.

What is the Condition Being Studied?

Relapsed or Refractory Acute Myeloid Leukemia
or
Intermediate-2/High Risk Myelodysplastic Syndrome

Who Can Participate in the Study?

Adults with Relapsed or Refractory Acute Myeloid Leukemia or Intermediate-2/High Risk Myelodysplastic Syndrome (MDS) who:
- Have liver and kidney function that is good enough for it to be safe to get the study drug

--- Patients with AML must be unlikely to get better with standard treatment
--- Patients with MDS must have had treatment failure with induction therapy

- Have not received an allogeneic stem cell transplantation
- Have not had previous treatment with radiotherapy, chemotherapy or immunotherapy in the 4 weeks prior to study treatment
- Do not have central nervous system leukemia
- Do not have active uncontrolled infections, including HIV, Hepatitis B or C

Age Group
Adults

What is Involved?

If you choose to join this study:
- You will have a screening visit that includes a physical exam, ECG test to see how your heart is working, blood work and a urine test

During Treatment:
- You will get the study drug, MGD006 for 28 days through a needle in your arm

Follow up at end of Treatment will include:
- Checking for any side effects, a physical exam, bone marrow aspirate and biopsy, blood work, and urine test

Study Details

Full Title
A Phase 1, First-in-Human, Dose Escalation Study of MGD006, a CD123 x CD3 Dual Affinity Re-Targeting (DART) Bi-Specific Antibody-Based Molecule, in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Intermediate-2/High Risk Myelodysplastic Syndrome
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB:PRO00057708
NCT:NCT02152956
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698