Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN

  • STATUS
    Recruiting
  • End date
    Dec 19, 2022
  • participants needed
    252
  • sponsor
    ImmunoGen, Inc.
Updated on 19 July 2021
cancer
blast crisis
flow cytometry
chronic myelomonocytic leukemia
leukemia
refractory acute myeloid leukemia (aml)
acute promyelocytic leukemia
blast cells

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.

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.

Details
Condition childhood ALL, Acute myeloid leukemia, MYELOPROLIFERATIVE DISORDER, Acute Myelogenous Leukemia (AML), Blastic Plasmacytoid Dendritic Cell Neoplasm, Myeloproliferative Neoplasms, Lymphocytic Leukemia, Acute, Acute Lymphocytic Leukaemia, leukemia, acute lymphoblastic, myeloproliferative neoplasm, myeloproliferative disorders, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all), acute myelogenous leukemia, anll, acute myeloblastic leukemia
Treatment IMGN632
Clinical Study IdentifierNCT03386513
SponsorImmunoGen, Inc.
Last Modified on19 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Disease Characteristics
Confirmation of CD123 positivity by flow cytometry or IHC. Patients who received prior CD123-targeting agents will be allowed as long as the blasts still have detectable CD123 expression
Expansion inclusion
Cohort 1 - Patients with relapsed or refractory BPDCN with 1-3 prior lines of therapy
Cohort 2 - Patients will have relapsed AML
Cohort 3 - Patients will have relapsed or refractory ALL (including any subtypes: B-cell, T-cell, Ph+, and Ph-)
Cohort 4 - Patients will have relapsed or refractory "other" hematologic malignancies not included in the cohorts above (eg, high-risk/very high-risk MDS, MPN, CMML, BP- CML). Other CD123+ malignancies may be considered upon discussion with the Sponsor
Cohort 5 - Patients will have relapsed or refractory (to non-intense therapies) AML
Cohort 6 - Patients with frontline BPDCN who have not received prior systemic therapy
Note: Patients in Cohort 6 may have received local therapy (radiotherapy
surgical excision, photodynamic therapy). Eligible patients must have a
recurrence or progression in the field of local therapy OR disease outside the
field of local therapy

Exclusion Criteria

Patients who, in the judgment of their treating physician, have appropriate standard of care therapies will be excluded from Cohorts 1 through 5
Frontline BPDCN patients 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 patients 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
Patients with a history of veno-occlusive disease of the liver
Patients 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 patients with prior local therapy (eg, radiotherapy), patients must not have received treatment within 14 days prior to drug administration on this study. 2. Relapsed or refractory BPDCN patients 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. Patients must have recovered to baseline from all acute toxicity from this prior therapy
Note: the exception that patients who have received a checkpoint inhibitor
must not have received that therapy within 28 days prior to drug
administration on this study
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