Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

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

Details

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.

Keywords

Blastic Plasmacytoid Dendritic Cell Neoplasm, Myeloproliferative Neoplasm, Antibody Drug Conjugate, Other Hematologic Malignancies, Myeloproliferative Neoplasms, CD123, MDS, Relapsed, Refractory, Acute Lymphocytic Leukaemia, Acute Myeloid Leukemia, Neoplasms, Myeloproliferative Disorders, IMGN632, Escalation and Expansion

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Disease Characteristics:
    1. 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.

You CAN'T join if...

  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.

Locations

  • UCLA accepting new patients
    Los Angeles California 90095 United States
  • City of Hope Medical Center accepting new patients
    Duarte California 91010 United States
  • Stanford accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ImmunoGen, Inc.
ID
NCT03386513
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 252 study participants
Last Updated