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ACTIVE NOT RECRUITING Phase 1

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

NCT03386513 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG IMGN632

Study Locations (20)

Other

  • Recherche Clinique-Hématologie — Amiens
  • CHU de Besancon, Hopital Jean Minjoz — Besançon
  • Institut Paoli Calmettes (Marseille) — Marseille
  • Hôpital St Antoine — Paris
  • CHU Bordeaux Hôpital Haut-Lévêque — Pessac

California

  • City of Hope Medical Center — Duarte
  • UCLA — Los Angeles
  • Stanford — Stanford

North Carolina

  • Novant Health Cancer Institute Hematology — Charlotte
  • Duke Cancer Institute — Durham
  • Novant Health Cancer Institute Hematology - Forsyth — Winston-Salem

New York

  • Roswell Park Cancer Institute — Buffalo
  • Memorial Sloan Kettering Cancer Center — New York

Texas

  • Baylor Scott & White University Medical Center — Dallas
  • MD Anderson Cancer Center — Houston

Arizona

  • Banner Health MD Anderson Cancer Center — Gilbert

Florida

  • Moffitt Cancer Center — Tampa

Maryland

  • University of Maryland Medical Center — Baltimore

Trial Details

FieldValue
Enrollment Target 179 participants
Start Date 2018-01-02
Est. Completion 2026-12-30
Phase Phase 1

Sponsor

AbbVie

603 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03386513

The ClinicalTrials.gov registry entry for NCT03386513 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 179 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Myeloproliferative Neoplasm appearing as the primary indexed condition, and to 1 intervention — of which IMGN632 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03386513 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03386513 about?

NCT03386513 is a clinical study titled "Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN". 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.

What is the current status of trial NCT03386513?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 179 participants. The study started on 2018-01-02. Estimated completion is 2026-12-30.

What conditions does trial NCT03386513 study?

This clinical trial studies the following conditions: Myeloproliferative Neoplasm, Blastic Plasmacytoid Dendritic Cell Neoplasm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03386513?

The interventions under investigation include: IMGN632 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03386513?

This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03386513 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial