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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
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.

Study Description
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Brief Summary:

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

Detailed Description:
The study completed a dose escalation phase, and is now enrolling in a dose expansion phase to further characterize the safety profile and to assess the efficacy of IMGN632 in patients with BPDCN. IMGN632 is administered by IV on Day 1 of each cycle, with cycles repeating every 21 days.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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:

  • Cohort 1: Relapsed or refractory BPDCN participants who have received 1-3 prior systemic therapies (incl. tagraxofusp-erzs and/or any other systemic therapy deemed appropriate for the treatment of BPDCN).
  • Cohort 6: Pivotal cohort for frontline BPDCN participants who have not received prior systemic therapy and participants with frontline BPDCN who have prior or concomitant hematologic malignancy (PCHM) and have not received prior systemic therapy.

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

 Drug: IMGN632
CD123-targeted ADC


Outcome Measures
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Primary Outcome Measures :
  1. To assess the rate of composite CR in BPDCN patients [ Time Frame: 21-day cycle ]
    CR+clinical CR [CRc]


Secondary Outcome Measures :
  1. To assess the duration of CR (DOCR) for patients with CR or CRc [ Time Frame: Up to 24 months ]
  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: Up to 24 months ]
  3. To assess the rate of CR+CRc+CRh [ Time Frame: Up to 24 months ]
  4. To assess the duration of CR+CRc+CRh [ Time Frame: Up to 24 months ]
  5. To assess ORR: CR+CRc+CRh+CRi+PR [ Time Frame: Up to 24 months ]
  6. To assess the duration of overall response [ Time Frame: Up to 24 months ]
  7. To assess OS [ Time Frame: Up to 24 months ]
  8. 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 ]
  9. To characterize the PK of IMGN632, total antibody, and FGN849 (the active catabolite) [ Time Frame: Up to 24 months ]
  10. To evaluate the potential immunogenicity of IMGN632 [ Time Frame: Up to 24 months ]
    ADA

  11. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Disease Characteristics:

    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.

  2. Expansion inclusion:

    • 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.

Exclusion Criteria:

  1. Participants who, in the judgment of their treating physician, have appropriate standard of care therapies will be excluded from Cohorts 1 through 5.
  2. 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.
  3. Participants with a history of veno-occlusive disease of the liver.
  4. 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.
  5. 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.

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: ImmunoGen Clinical Trials 781-895-0600 medicalaffairs@immunogen.com

Locations
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Sponsors and Collaborators
ImmunoGen, Inc.
Investigators
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Study Director: Patrick Zweidler-McKay, MD ImmunoGen, Inc.
More Information
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Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT03386513    
Other Study ID Numbers: IMGN632-0801
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ImmunoGen, Inc.:
Antibody Drug Conjugate
Other Hematologic Malignancies
Myeloproliferative Neoplasms
CD123
MDS
 Relapsed, Refractory
Acute Lymphocytic Leukaemia
Blastic Plasmacytoid Dendritic Cell Neoplasm
Acute Myeloid Leukemia
Additional relevant MeSH terms:
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Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases