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ImmunoGen:0801 Phase1 IMGN632 in R/R CD123+AML/other CD123+HM (Leukemia) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out what dose of the study drug IMGN632 is a good idea for patients who have cancer and to learn what effects, good and/or bad, the study drug may have on patients.
What is the Condition Being Studied?
CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies

Who Can Participate in the Study?

Adult men and women who have:
- First relapse of CD123+ AML
- Relapse of CD123+ ALL
- Relapse of CD123+ "other" hematologic malignancies
- Relapse of CD123+ BPDCN

Age Group
Adults

What is Involved?

If you choose to join this study, you will:

- Go through a screening process that includes:
-- Review of medical history
-- Having a bone marrow aspirate (removal of soft tissue in the bone) that must be done at Duke
-- Blood tests
-- Physical exams
-- PET/CT Scans (if needed)
-- ECHO/MUGA scan
-- Cheek swab (if enrolled on dose expansion)
-- other tests

- Be in one of the following groups:
-- The first phase of the study which will find out the highest and safe dose of the study drug IMGN632 through infusion at Duke clinic
OR
-- You will get one of multiple expansion phases

- Have a complete physical exam, vital signs, and performance status
- Have symptom-directed physical exam
- Have blood tests for safety and PK
- Have urine tests
- Have bone marrow aspirate performed as needed
- Have CT/PET scans (if needed)
- Have Skin lesion assessment/biopsy (if needed)
- Have ECG during screening while on study drug

Study Details

Full Title
A Phase 1, Multi-center, Open-label Study of IMGN632 Administered Intravenously in Patients with Relapsed/Refractory CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB: PRO00092685
NCT: NCT03386513
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698