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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ImmunoGen, Inc.

Criteria

Inclusion Criteria:

1. Disease Characteristics:

a. 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.

2. 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:

1. Patients 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 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.

3. Patients with a history of veno-occlusive disease of the liver.

4. 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.

5. 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.