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Can a targeted drug hit the mark in Hard-to-Treat blood cancers?

NCT ID NCT03386513

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests an experimental drug called IMGN632 in people with certain blood cancers, including acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm. The drug is designed to find and attack cancer cells that carry a protein called CD123 on their surface. Researchers are looking at how safe the drug is, what side effects it causes, and whether it can help shrink or eliminate the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IMGN632, an antibody-drug conjugate that targets CD123 on cancer cells
What this could lead to
If it works, IMGN632 could offer a new treatment option for people with certain blood cancers that have not responded to other therapies.
What could go wrong
This is an early-phase trial, so the drug may not work as hoped or may cause side effects. The results will need confirmation in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

179 people

The number who actually took part.

Started

Jan 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Disease Characteristics: a. 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 2 - Participants with relapsed AML * Cohort 3 - Participants with relapsed relapsed or refractory ALL (including any subtypes: B-cell, T-cell, Ph+ and Ph-) * Cohort 4 - Participants with relapsed or refractory other hematologic malignancies not included in the cohorts above (eg, high risk/very high-risk MDS, MPN, CMML, BP-CML). * Cohort 5 - Participants with relapsed relapsed or refractory (to nonintense therapies) CD123+ AML. * 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. Exclusion Criteria: 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 (sinusoidal obstruction syndrome) 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.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia acute myeloid leukemia Blastic Plasmacytoid Dendritic Cell Neoplasm CD4+/CD56+ hematodermic neoplasm Myeloproliferative Disorders myeloproliferative neoplasm Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blastic plasmacytoid dendritic cell neoplasm Myeloproliferative neoplasm

Contacts and locations

Locations

  • Azienda ospedaliera Santa Maria della Misericordia

    Perugia, 06132, Italy

  • Banner Health MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Baylor Scott & White University Medical Center

    Dallas, Texas, 75246, United States

  • CHU Bordeaux Hôpital Haut-Lévêque

    Pessac, 33600, France

  • CHU de Besancon, Hopital Jean Minjoz

    Besançon, 25030, France

  • Churchill Hospital - Oxford

    Oxford, OX3 7LE, United Kingdom

  • City of Hope Medical Center

    Duarte, California, 91010, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Institute

    Durham, North Carolina, 27710, United States

  • Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Hospital Universitari I Politècnic La Fe

    Valencia, 46026, Spain

  • Hôpital St Antoine

    Paris, France

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi

    Bologna, 40138, Italy

  • Institut Paoli Calmettes (Marseille)

    Marseille, 13009, France

  • Instituto Europeo di Oncologia

    Milan, 20141, Italy

  • Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014, Italy

  • MD Anderson Cancer Center

    Houston, Texas, 77030-7095, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Novant Health Cancer Institute Hematology

    Charlotte, North Carolina, 28204, United States

  • Novant Health Cancer Institute Hematology - Forsyth

    Winston-Salem, North Carolina, 27103, United States

  • Recherche Clinique-Hématologie

    Amiens, France

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Stanford

    Stanford, California, 94305, United States

  • UCLA

    Los Angeles, California, 90095, United States

  • University Hospital of Cologne

    Cologne, 50937, Germany

  • University Hospital of Leipzig

    Leipzig, 04103, Germany

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

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