Study of IMGN632 in Patients With Relapse/Refractory AML, BPDCN, ALL, Other CD123+ Hem Malignancies



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/10/2019
Start Date:January 4, 2018
End Date:February 2021
Contact:ImmunoGen Clinical Trials
Email:scientificaffairs@immunogen.com
Phone:781-895-0600

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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

This is an open-label, multi-center, Phase 1 study to determine the MTD and assess the
safety, tolerability, PK, immunogenicity, and preliminary anti-leukemia activity of IMGN632
when administered as monotherapy to patients with CD123+ disease.

The study comprises a dose escalation phase followed by a dose expansion phase to further
characterize the safety profile and confirm the MTD. IMGN632 will be administered IV on Day 1
of each cycle, with cycles repeating every 21 days. Treatment will continue for up to 2
cycles (6 weeks) in the absence of disease progression (PD), treatment intolerance, or
withdrawal of consent.

Inclusion Criteria:

- Disease Characteristics and allowable prior therapy:

- Patients in dose escalation and all expansion cohorts except first relapse AML may
have received up to three prior lines of therapy.

- Dose Escalation - Relapsed or refractory AML (excluding acute promyelocytic leukemia)
or BPDCN, based on World Health Organization Classification. All patients enrolled on
this study will have CD123+ disease.

- Dose Expansion Cohort #1 - Patients will have relapse of CD123+ BPDCN. Patients with
prior CD123-targeting agents will be allowed as long as the blasts still have
detectable CD123 expression.

- Dose Expansion Cohort #2 - Patients will have first relapse of CD123+ AML.

- Dose Expansion Cohort #3 - Patients will have relapse of CD123+ ALL.

- Dose Expansion Cohort #4 - Patients will have relapse of CD123+ "other" hematologic
malignancies not included in the cohorts above (e.g., high-risk/very high-risk MDS,
MPN, CMML, CML blast crisis). Other CD123+ malignancies may be considered upon
discussion with the Medical Monitor.

Exclusion Criteria:

- Patients who, in the judgment of their treating physician, have available standard of
care therapies will be excluded

- AML patients with active central nervous system (CNS) disease will be excluded.

- Patients with a history of venous occlusive disease of the liver

- Patients with a history of Grade 3-4 capillary leak syndrome, or non-cardiac Grade
edema are ineligible, e.g., related to SL-401 or other etiology

- Myocardial infarction within six months prior to enrollment or has New York Heart
Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled
ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active
conduction system abnormalities prior to study entry

- Patients who have received any anti-cancer therapy including chemotherapy,
immunotherapy, radiotherapy, hormonal, biologic, or any investigational agents within
14 days or five half-lives, whichever is greater (with exception of hydroxyurea),
prior to drug administration on this study.
We found this trial at
5
sites
Houston, Texas 77030
Principal Investigator: Hagop Kantarjian, MD
Phone: 713-792-7321
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-975-8080
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Eunice Wang, MD
Phone: 716-845-4971
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-4038
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Valencia, 46026
Principal Investigator: Pau Montesinos, MD
Phone: +34 961 245 876
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