Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03386513|
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : March 15, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
This is an open-label, multi-center, Phase 1/2 study to determine the MTD and assess the safety, tolerability, PK, immunogenicity, and anti-leukemia activity of IMGN632 when administered as monotherapy to patients with CD123+ disease.
The study is enrolling a pivotal cohort of frontline BPDCN patients and a cohort of relapsed/refractory BPDCN patients.
|Condition or disease||Intervention/treatment||Phase|
|Blastic Plasmacytoid Dendritic Cell Neoplasm Myeloproliferative Neoplasm||Drug: IMGN632||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||252 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2, Multi-center, Open-label Study of IMGN632 Monotherapy Administered Intravenously in Patients With CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies|
|Actual Study Start Date :||January 2, 2018|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2025|
Experimental: Escalation and Expansion
Escalation: IMGN632 was administered by IV on 2 different schedules for participants with relapsed/refractory AML, ALL, or BPDCN.
Expansion: the study is currently enrolling in 2 BPDCN expansion cohorts at the RP2D:
Other cohorts not currently enrolling:
• Cohort 2: Relapsed AML; Cohort 3: Relapsed or refractory ALL; Cohort 4: Other relapsed or refractory hematologic malignancies; Cohort 5: Relapsed or refractory AML at alternate dose or schedule
- To assess the rate of composite CR in BPDCN patients [ Time Frame: 21-day cycle ]CR+clinical CR [CRc]
- To assess the duration of CR (DOCR) for patients with CR or CRc [ Time Frame: Up to 24 months ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: Up to 24 months ]
- To assess the rate of CR+CRc+CRh [ Time Frame: Up to 24 months ]
- To assess the duration of CR+CRc+CRh [ Time Frame: Up to 24 months ]
- To assess ORR: CR+CRc+CRh+CRi+PR [ Time Frame: Up to 24 months ]
- To assess the duration of overall response [ Time Frame: Up to 24 months ]
- To assess OS [ Time Frame: Up to 24 months ]
- To assess the percent of BPDCN patients able to bridge to stem cell transplant in the frontline and relapsed/refractory populations separately [ Time Frame: Up to 24 months ]
- To characterize the PK of IMGN632, total antibody, and FGN849 (the active catabolite) [ Time Frame: Up to 24 months ]
- To evaluate the potential immunogenicity of IMGN632 [ Time Frame: Up to 24 months ]ADA
- To assess transfusion independence [ Time Frame: Up to 24 months ]Conversion rate to independence of red blood cell (RBC) and platelet transfusion relative to baseline
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
a. Confirmation of CD123 positivity by flow cytometry or IHC. Participants who received prior CD123-targeting agents will be allowed as long as the blasts still have detectable CD123 expression.
- Cohort 1 - Participants with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN) with 1-3 prior lines of therapy
- Cohort 6 - Participants with frontline de novo BPDCN at screening who have not received prior systemic therapy and participants with frontline BPDCN who have PCHM and have not received prior systemic therapy.
Note: Participants in Cohort 6 may have received local therapy (radiotherapy, surgical excision, photodynamic therapy). Eligible participants must have a recurrence or progression in the field of local therapy OR disease outside the field of local therapy.
- Participants who, in the judgment of their treating physician, have appropriate standard of care therapies will be excluded from Cohorts 1 through 5.
- Frontline BPDCN participants with central nervous system (CNS) disease will be excluded. A lumbar puncture must be performed during the 28-day screening period, prior to drug administration. Relapsed or refractory BPDCN participants with a known history of CNS disease must have been treated locally, have at least 1 lumbar puncture with no evidence of CNS disease, and must be clinically stable prior to first dose. Concurrent therapy for CNS prophylaxis or continuation of therapy for controlled CNS disease is permitted with the approval of the Sponsor.
- Participants with a history of veno-occlusive disease of the liver.
- Participants with a history of Grade 4 capillary leak syndrome, or non-cardiac Grade 4 edema are ineligible, eg, related to tagraxofusp-erzs or other etiology.
- Interval from prior cancer therapy: 1. For frontline BPDCN participants with prior local therapy (eg, radiotherapy), participants must not have received treatment within 14 days prior to drug administration on this study. 2. Relapsed or refractory BPDCN participants must not have received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational agents within 14 days prior to drug administration on this study. Participants must have recovered to baseline from all acute toxicity from this prior therapy.
Note: the exception that participants who have received a checkpoint inhibitor must not have received that therapy within 28 days prior to drug administration on this study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386513
|Contact: ImmunoGen Clinical Trialsfirstname.lastname@example.org|
|Study Director:||Patrick Zweidler-McKay, MD||ImmunoGen, Inc.|
|Responsible Party:||ImmunoGen, Inc.|
|Other Study ID Numbers:||
|First Posted:||December 29, 2017 Key Record Dates|
|Last Update Posted:||March 15, 2023|
|Last Verified:||March 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Antibody Drug Conjugate
Other Hematologic Malignancies
Acute Lymphocytic Leukaemia
Blastic Plasmacytoid Dendritic Cell Neoplasm
Acute Myeloid Leukemia
Bone Marrow Diseases