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Antibody-Drug Conjugate

IMGN632 for BPDCN

Phase 1 & 2
Waitlist Available
Research Sponsored by ImmunoGen, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN) with 1-3 prior lines of therapy
Participants with relapsed relapsed or refractory (to nonintense therapies) CD123+ AML
Must not have
Frontline BPDCN participants with central nervous system (CNS) disease
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Summary

This trial is studying a new drug, IMGN632, to see if it is safe and effective in treating patients with blood cancer.

Who is the study for?
This trial is for patients with a rare blood cancer called BPDCN. It's open to those who have never had systemic treatment (Cohort 6) or have tried up to three treatments without success (Cohort 1). Participants must show CD123+ on their cancer cells and can't join if they've got CNS disease, severe swelling issues, liver veno-occlusive disease, or suitable standard care options available.Check my eligibility
What is being tested?
The study tests IMGN632 as a solo treatment for BPDCN. Researchers want to find the highest dose patients can take without serious side effects (MTD), how safe it is, how the body processes it, if it causes immune reactions, and its effectiveness against leukemia.See study design
What are the potential side effects?
Specific side effects of IMGN632 aren't listed here but generally could include symptoms like fatigue, nausea, allergic reactions related to infusion, potential organ inflammation and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have BPDCN and have undergone 1-3 treatments.
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My AML has returned or didn't respond to initial mild treatments and tests positive for CD123.
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I have BPDCN and haven't had any systemic therapy yet.
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My leukemia has returned or is not responding to treatment.
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My blood cancer has returned or didn't respond to treatment.
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My AML cancer has returned after treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have BPDCN that has spread to my brain or spinal cord.
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I haven't had cancer treatment in the last 14 days and have recovered from any side effects.
Select...
I have had a liver condition called veno-occlusive disease.
Select...
I have never had severe swelling or capillary leak syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To assess the rate of composite CR in BPDCN patients
Secondary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
To assess ORR: CR+CRc+CRh+CRi+PR
To assess OS
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Escalation and ExpansionExperimental Treatment1 Intervention
Escalation: IMGN632 was administered by IV on 2 different schedules for participants with relapsed/refractory AML, ALL, or BPDCN. Expansion: IMGN632 was administered by IV: 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 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 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.

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Who is running the clinical trial?

ImmunoGen, Inc.Lead Sponsor
32 Previous Clinical Trials
3,635 Total Patients Enrolled
Patrick Zweidler-McKay, MDStudy DirectorImmunoGen, Inc.
2 Previous Clinical Trials
280 Total Patients Enrolled

Media Library

IMGN632 (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT03386513 — Phase 1 & 2
Blastic Plasmacytoid Dendritic Cell Neoplasm Research Study Groups: Escalation and Expansion
Blastic Plasmacytoid Dendritic Cell Neoplasm Clinical Trial 2023: IMGN632 Highlights & Side Effects. Trial Name: NCT03386513 — Phase 1 & 2
IMGN632 (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03386513 — Phase 1 & 2
~9 spots leftby Dec 2024
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