Cure My Disease

Don't miss your cure!

 Log in / Sign up

Experimental drug HDP-101 targets Hard-to-Treat myeloma

NCT ID NCT04879043

Disease control Sponsor: Heidelberg Pharma AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests an experimental drug, HDP-101, in people with multiple myeloma or related plasma cell disorders. The goal is to see if the drug is safe and can shrink tumors. Participants have already tried other treatments, including stem cell transplant or are not eligible for one.

What this could mean

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

Active substance
HDP-101, an experimental drug given as an infusion
What this could lead to
If successful, HDP-101 could offer a new treatment option for patients with multiple myeloma who have exhausted other therapies.
What could go wrong
This is an early, first-in-human trial with a small number of participants, so safety and effectiveness are not yet proven. There may be unforeseen side effects.

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

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Sep 2028

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: * Male or female aged ≥18 years. * Life expectancy \>12 weeks. * Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2. * A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG). * Must have undergone SCT or is considered transplant ineligible. * Must have undergone prior treatments with antimyeloma therapy which must have included an immunomodulatory drug, proteasome inhibitor, and anti-CD38 treatment, alone or in combination. In addition, the patient should either refractory or intolerant to any established standard of care therapy providing a meaningful clinical benefit for the patient assessed by the Investigator. * Measurable disease as per IMWG criteria. * Adequate organ system function as defined in protocol. Exclusion Criteria: * For patient entering the Phase 2a part only: Prior treatment with any approved or experimental BCMA-targeting modalities are not allowed. * Known central nervous system involvement. * Plasma cell leukemia. * History of congestive heart failure. * Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT. * Symptomatic graft versus host disease post allogenic hemopoietic cell transplant within 12 months prior to the first study treatment infusion. * Radiotherapy within 21 days prior to the first study treatment infusion. * History of any other malignancy known to be active. * Known human immunodeficiency virus infection. * Patients with active infection requiring systemic anti-infective. * Patients with positive test results for hepatitis B surface antigen or Hepatitis B core antigen. * Patients with positive test results for hepatitis C virus (HCV) infection. * Current active liver or biliary disease.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Multiple myeloma are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

plasma cell myeloma plasma cell neoplasm

As listed by the trial registrant

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

Multiple myeloma Plasma cell disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AIDPORT Sp. zo.o.

    RECRUITING

    Skórzewo, 60-185, Poland

  • Arensia Clinics SRL

    RECRUITING

    Bucharest, Romania

  • Asklepios Klinik Altona, Haematologie und internistische Onkologie

    WITHDRAWN

    Hamburg, 22763, Germany

  • Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie

    WITHDRAWN

    Berlin, 12203, Germany

  • Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III

    WITHDRAWN

    Chemnitz, 09116, Germany

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • MICS Centrum Medyczne Torun

    RECRUITING

    Torun, 87-100, Poland

  • Mount Sinai, The Tisch Cancer Instutute

    RECRUITING

    New York, New York, 10029, United States

  • National Institute of Oncology, Department of Oncological Internal Medicine

    WITHDRAWN

    Budapest, 1122, Hungary

  • Nebraska Cancer Institute

    NOT_YET_RECRUITING

    Omaha, Nebraska, 68130, United States

  • Norton Healthcare, Inc.

    NOT_YET_RECRUITING

    Louisville, Kentucky, 40202, United States

  • Oncology Institute Prof. Dr. Ion Chiricuta I.O.C.N.

    NOT_YET_RECRUITING

    Cluj-Napoca, Romania

  • Pratia Onkologia Katowice

    RECRUITING

    Katowice, 40-568, Poland

  • Pratia Onkologia Kraków

    RECRUITING

    Krakow, 40-519, Poland

  • Pécsi Tudományegyetem Klinikai Központ

    NOT_YET_RECRUITING

    Pécs, 7624, Hungary

  • Semmelweis University, Belgyogyaszati es Onkologiai Klinika

    RECRUITING

    Budapest, 1083, Hungary

  • Szpital Wojewodzki w Opolu

    WITHDRAWN

    Opole, 45-061, Poland

  • UKSH Campus Lübeck Klinik für Hämatologie und Onkologie

    ACTIVE_NOT_RECRUITING

    Lübeck, 23538, Germany

  • Universitätsklinikum Heidelberg

    ACTIVE_NOT_RECRUITING

    Heidelberg, 69120, Germany

  • Universitätsklinikum Köln

    WITHDRAWN

    Cologne, 50937, Germany

  • Universitätsklinikum Mainz

    WITHDRAWN

    Mainz, 55131, Germany

  • Universitätsklinikum Schleswig-Holstein

    WITHDRAWN

    Kiel, 24105, Germany

  • Winship Cancer Institute of Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

    WITHDRAWN

    Lodz, 93-513, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.