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New hope for Hard-to-Treat myeloma: first human trial launches

NCT ID NCT05862012

Disease control Sponsor: Ichnos Sciences SA 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new drug called ISB 2001 in people with multiple myeloma that has returned or stopped responding to standard treatments. The main goals are to check the drug's safety and how well it fights the cancer. About 200 participants will receive the drug in increasing doses to find the best and safest amount.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 200 people

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

Started

Nov 2023

Expected to finish

Jul 2027

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. Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma 2. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less 3. Must have adequate hematologic, hepatic, renal, and cardiac functions Exclusion Criteria: 1. Active malignant central nervous system involvement 2. Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1 3. History of autoimmune disease requiring systemic immunosuppressive therapy 4. Any concurrent or uncontrolled medical, comorbid, psychiatric or social condition that would limit compliance with study procedures, interfere with the study results, substantially increase the risk of AEs, compromise ability to provide written informed consent or, in the opinion of the Investigator, constitute a hazard for participating in this study. 5. Female subjects who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on Day 1 before first dose of ISB 2001.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Relapsed/refractory multiple myeloma

How to take part

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

  1. The places running it

    22 sites in 6 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • ASST Spedali Civili di Brescia

    ACTIVE_NOT_RECRUITING

    Brescia, Lombardy, 25123, Italy

  • Apollo Cancer Centers

    ACTIVE_NOT_RECRUITING

    Hyderabad, Telangana, 500033, India

  • Apollo Hospital International Limited

    ACTIVE_NOT_RECRUITING

    Gandhinagar, Gujarat, 382428, India

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • CHRU Lille

    RECRUITING

    Lille, Hauts-de-France, 59800, France

  • CHU Poiters - Hospital la Miletrie

    RECRUITING

    Poitiers, New Aquitaine, 86021, France

  • CHU de Nantes - Hotel Dieu

    RECRUITING

    Nantes, Pays de la Loire Region, 44093, France

  • Centro Integral Oncologici Clara Campal

    ACTIVE_NOT_RECRUITING

    Madrid, Madrid, 28050, Spain

  • Clinica Universidad de Nevarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Concord Hospital

    RECRUITING

    Concord, New South Wales, 2139, Australia

  • Deenanath Mangeshkar Hospital and Research Centre

    ACTIVE_NOT_RECRUITING

    Pune, Maharashta, 411004, India

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, Lombardy, 20122, Italy

  • Froedtert Hospital & the Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Groupe Hospitalier Pitie-Salpetriere

    RECRUITING

    Paris, Île-de-France Region, 75013, France

  • HCG Hospital

    ACTIVE_NOT_RECRUITING

    Bangalore, India

  • Health Care Global Enterprises Ltd.

    ACTIVE_NOT_RECRUITING

    Bangalore, Karnataka, 560027, India

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, Catalonia, 08036, Spain

  • Institut Catala de Oncologia (ICO)

    RECRUITING

    Badalona, Catalonia, 08916, Spain

  • Instituto de Investigacion Biomedica de Salamanca (IBSAL)

    RECRUITING

    Salamanca, Castile de Leon, 37007, Spain

  • Linear Clinical Research

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Oslo University Hospital

    RECRUITING

    Oslo, Oslo, 0372, Norway

  • Peter MacCallum Cancer Center

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Pindara Private Hospital

    RECRUITING

    Benowa, Queensland, 4217, Australia

  • St. Vincent's Hospital Melbourne

    RECRUITING

    Fitzroy, Victoria, 3065, Australia

  • Standford Cancer Institute

    RECRUITING

    Palo Alto, California, 94304, United States

  • Sylvester Cancer Center

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33136, United States

  • Tennessee Oncology

    ACTIVE_NOT_RECRUITING

    Nashville, Tennessee, 37203, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Virginia Commonwealth University (VCU)

    ACTIVE_NOT_RECRUITING

    Richmond, Virginia, 23298, United States

  • Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

More trials for these conditions

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