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New CAR-T therapy aims to tackle Hard-to-Treat multiple myeloma

NCT ID NCT06615479

Disease control Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 16, 2026 · Updated 7 times

Summary

This phase 3 trial is testing a new CAR-T cell therapy called arlo-cel against standard treatments for adults with multiple myeloma that has come back or stopped responding to previous therapies. About 440 participants will receive either arlo-cel or a standard regimen. The study will compare how long the cancer stays under control and how well patients respond.

What this could mean

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

Active substance
arlocabtagene autoleucel (arlo-cel), a CAR-T cell therapy targeting GPRC5D
What this could lead to
If successful, this could offer a more effective treatment option for people with multiple myeloma that has returned or not responded to prior therapies.
What could go wrong
This is an early-phase 3 trial, so results are not yet confirmed. CAR-T therapies can cause serious side effects like cytokine release syndrome and neurological problems.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 440 people

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

Started

Mar 2025

Expected to finish

Jun 2032

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 * Participants must have relapsed or refractory multiple myeloma (RRMM). * Participants must have received at least 1 but no greater than 3 prior multiple myeloma (MM) regimens which may include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody and have prior exposure to lenalidomide. * Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria. * Participants must have measurable disease during screening. * Participants must have adequate organ function. * Participants must have an Eastern Cooperative Oncology group performance status 0 or 1. Exclusion Criteria * Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM). * Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease. * Participants must not need urgent treatment due to rapidly progressing MM. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Get notified about this study

Sign up to get updates when this study changes or when new studies for Relapsed or refractory multiple myeloma (RRMM) are added.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma Recurrence refractory plasma cell neoplasm

As listed by the trial registrant

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

Relapsed or refractory multiple myeloma (RRMM)

How to take part

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

  1. The places running it

    133 sites in 31 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

  • A. C. Camargo Cancer Center

    RECRUITING

    São Paulo, São Paulo, 01509-010, Brazil

  • AHN West Penn Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Aarhus Universitetshospital, Skejby

    RECRUITING

    Aarhus, Central Jutland, 8200, Denmark

  • Addenbrooke's Hospital

    RECRUITING

    Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

  • Amsterdam UMC, locatie VUmc

    RECRUITING

    Amsterdam, North Holland, 1081 HV, Netherlands

  • Antwerp University Hospital

    RECRUITING

    Edegem, Antwerpen, 2650, Belgium

  • Arthur J.E. Child Comprehensive Cancer Centre

    RECRUITING

    Calgary, Alberta, T2N 5G2, Canada

  • Asan Medical Center

    RECRUITING

    Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

  • Attikon General University Hospital

    RECRUITING

    Chaïdári, Attikí, 12462, Greece

  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

    RECRUITING

    Turin, Piedmont, 10126, Italy

  • Baptist MD Anderson Cancer Center

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • CHUS - Hospital Clinico Universitario

    RECRUITING

    Santiago de Compostela, A Coruña [La Coruña], 15706, Spain

  • CIUSSS de l'Est-de-l'Île-de-Montréal

    RECRUITING

    Montreal, Quebec, H1T 2M4, Canada

  • Cantonal Hospital St.Gallen

    RECRUITING

    Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

  • Centre Hospitalier Lyon Sud

    RECRUITING

    Pierre-Bénite, Rhône, 69310, France

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

    RECRUITING

    Nantes, Pays de la Loire Region, 44000, France

  • Centrum Onkologii Ziemi Lubelskiej

    RECRUITING

    Lublin, Lublin Voivodeship, 20-090, Poland

  • Charité Campus Virchow-Klinikum

    RECRUITING

    Berlin, 13353, Germany

  • China Medical University Hospital

    RECRUITING

    Taichung, 404332, Taiwan

  • Churchill Hospital

    RECRUITING

    Oxford, Oxfordshire, OX3 7LE, United Kingdom

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Cliniques universitaires Saint-Luc

    RECRUITING

    Brussels, Bruxelles-Capitale, Région de, 1200, Belgium

  • Debreceni Egyetem Klinikai Kozpont

    RECRUITING

    Debrecen, Hajdú-Bihar, 4032, Hungary

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi

    RECRUITING

    Ankara, 06200, Turkey (Türkiye)

  • Evangelismos General Hospital of Athens

    RECRUITING

    Athens, Attikí, 106 76, Greece

  • Fakultni nemocnice Hradec Kralove

    RECRUITING

    Hradec Králové, Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Ostrava

    RECRUITING

    Ostrava, Moravian-Silesian Region, 708 52, Czechia

  • Fakultní nemocnice Brno Bohunice

    RECRUITING

    Brno, Brno-město, 625 00, Czechia

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    RECRUITING

    Milan, Lombardy, 20133, Italy

  • Freeman Hospital

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Fundeni Clinical Institute

    RECRUITING

    Bucharest, Bucharest, 022328, Romania

  • Georgetown University Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, Jerusalem, 9112001, Israel

  • Hamilton Health Sciences-Juravinski Cancer Centre

    RECRUITING

    Hamilton, Ontario, L8V5C2, Canada

  • Hanusch-Krankenhaus

    RECRUITING

    Vienna, 1140, Austria

  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

    RECRUITING

    Helsinki, Uusimaa, 00029, Finland

  • Henri Mondor Hospital

    RECRUITING

    Créteil, Val-de-Marne, 94010, France

  • Hopital Claude Huriez - CHU de Lille

    RECRUITING

    Lille, Nord, 59000, France

  • Hospital Aleman

    RECRUITING

    Buenos Aires, Buenos Aires F.D., C1118AAT, Argentina

  • Hospital Italiano de Buenos Aires

    RECRUITING

    ABB, Buenos Aires F.D., C1199ABB, Argentina

  • Hospital Universitari Son Espases

    RECRUITING

    Palma, Balears [Baleares], 07120, Spain

  • Hospital Universitario Virgen Nieves

    RECRUITING

    Granada, 18012, Spain

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Hyogo Medical University Hospital

    RECRUITING

    Nishinomiya, Hyōgo, 663-8501, Japan

  • Hôpital Saint-Louis

    RECRUITING

    Paris, 75010, France

  • IRCCS AOM Azienda Ospedaliera Metropolitana

    RECRUITING

    Genova, 16132, Italy

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

    RECRUITING

    Bologna, 40138, Italy

  • Inselspital Bern

    RECRUITING

    Bern, Canton of Bern, 3010, Switzerland

  • Institut Catalan d Oncologia (ICO) - Badalona

    RECRUITING

    Badalona, Barcelona [Barcelona], 08916, Spain

  • Instituto D'Or de Pesquisa e Ensino (IDOR)

    RECRUITING

    São Paulo, 01401-002, Brazil

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE

    RECRUITING

    Porto, 4200-072, Portugal

  • Institutul Regional de Oncologie

    RECRUITING

    Iași, 700483, Romania

  • Istituto Clinico Humanitas

    RECRUITING

    Rozzano, Milano, 20089, Italy

  • Japanese Red Cross Medical Center

    RECRUITING

    Shibuya-ku, Tokyo, 150-8935, Japan

  • Kanazawa University Hospital

    RECRUITING

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Karolinska Universitetssjukhuset Huddinge

    RECRUITING

    Huddinge, 141 86, Sweden

  • Klinikum Chemnitz - Flemmingstraße

    RECRUITING

    Chemnitz, Saxony, 09116, Germany

  • Klinikum Nuernberg Nord

    RECRUITING

    Nuremberg, 90419, Germany

  • Kumamoto University Hospital

    RECRUITING

    Kumamoto, 860-8556, Japan

  • Kyushu University Hospital

    RECRUITING

    Fukuoka, 812-8582, Japan

  • Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Liverpool Hospital

    RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • Local Institution - 0012

    NOT_YET_RECRUITING

    Nova Lima, Minas Gerais, 34000-000, Brazil

  • Local Institution - 0084

    NOT_YET_RECRUITING

    Katowice, 40-519, Poland

  • Local Institution - 0097

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Local Institution - 0125

    WITHDRAWN

    Budapest, 1097, Hungary

  • Local Institution - 0178

    NOT_YET_RECRUITING

    Riyadh, 12713, Saudi Arabia

  • Local Institution - 0181

    WITHDRAWN

    Singapore, Central Singapore, 169608, Singapore

  • Local Institution - 0214

    WITHDRAWN

    ABB, Buenos Aires F.D., C1199ABB, Argentina

  • Local Institution - 0219

    WITHDRAWN

    Minneapolis, Minnesota, 55455, United States

  • Local Institution - 0221

    WITHDRAWN

    Stony Brook, New York, 11794, United States

  • Local Institution - 0227

    WITHDRAWN

    Charleston, South Carolina, 29425, United States

  • Local Institution - 0228

    WITHDRAWN

    Orlando, Florida, 32804, United States

  • Louisiana State University Health Sciences Shreveport

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • Maastricht UMC+

    RECRUITING

    Maastricht, Limburg, 6229 HX, Netherlands

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, Lower Saxony, 30625, Germany

  • Monash Health

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Nagoya City University Hospital

    RECRUITING

    Nagoya, Aichi-ken, 467-8602, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • National Hospital Organization Okayama Medical Center

    RECRUITING

    Okayama, 701-1192, Japan

  • National Taiwan University Cancer Center (NTUCC)

    RECRUITING

    Taipei City, Taipei, 106, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10002, Taiwan

  • National University Hospital

    RECRUITING

    Singapore, Central Singapore, 119074, Singapore

  • Odense Universitetshospital

    RECRUITING

    Odense, Region Syddanmark, 5000, Denmark

  • Ordensklinikum Linz GmbH Elisabethinen

    RECRUITING

    Linz, Upper Austria, 4020, Austria

  • Osaka Red Cross Hospital

    RECRUITING

    Osaka, 543-8555, Japan

  • Oulun yliopistollinen sairaala

    RECRUITING

    Oulu, 90220, Finland

  • P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale

    RECRUITING

    Udine, 33100, Italy

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Princess Alexandra Hospital

    RECRUITING

    Brisbane, Queensland, 4102, Australia

  • QEII Health Sciences Centre - Victoria General Site

    RECRUITING

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Radboudumc

    RECRUITING

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • Rigshospitalet

    RECRUITING

    Copenhagen, Capital Region, 2100, Denmark

  • Roskilde Sygehus

    RECRUITING

    Roskilde, Region Sjælland, 4000, Denmark

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Sahlgrenska Universitetssjukhuset

    RECRUITING

    Gothenburg, Västra Götalands Län [se-14], 413 45, Sweden

  • Samsung Medical Center

    RECRUITING

    Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, Central District, 5262100, Israel

  • Sheffield Teaching Hospitals NHS Foundation Trust

    RECRUITING

    Sheffield, S10 2JF, United Kingdom

  • Skånes Universitetssjukhus Lund

    RECRUITING

    Lund, 222 42, Sweden

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    RECRUITING

    São Paulo, 05652-900, Brazil

  • Sourasky Medical Center

    RECRUITING

    Tel Aviv, Tell Abīb, 6423906, Israel

  • Spitalul Universitar de Urgență București

    RECRUITING

    Bucharest, 050098, Romania

  • Sykehusapoteket Ull

    RECRUITING

    Oslo, 0450, Norway

  • TUM Klinikum

    RECRUITING

    Munich, Bavaria, 81675, Germany

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 11217, Taiwan

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    RECRUITING

    Seoul, Seoul-teukbyeolsi [Seoul], 06591, South Korea

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • Turku University Hospital

    RECRUITING

    Turku, 20251, Finland

  • UCLA Hematology/Oncology - Santa Monica

    RECRUITING

    Los Angeles, California, 90404, United States

  • UZ Gent

    RECRUITING

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Universitaetsklinikum Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • Universitaetsklinikum Heidelberg

    RECRUITING

    Heidelberg, D-69120, Germany

  • Universitaetsklinikum Magdeburg

    RECRUITING

    Magdeburg, Saxony-Anhalt, 39120, Germany

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    RECRUITING

    Kiel, Schleswig-Holstein, 24105, Germany

  • Universitaetsklinikum Wuerzburg

    RECRUITING

    Würzburg, 97080, Germany

  • Universitair Medisch Centrum Utrecht

    RECRUITING

    Utrecht, 3584 CX, Netherlands

  • University College London Hospital

    RECRUITING

    London, London, City of, NW1 2PG, United Kingdom

  • University Hospital of Patras

    RECRUITING

    Pátrai, Achaḯa, 26504, Greece

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35205, United States

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center

    RECRUITING

    Orange, California, 92868, United States

  • University of Miami Hospital and Clinics, Sylvester Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Universitätsklinikum Leipzig

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne

    RECRUITING

    Yvoir, Namur, 5530, Belgium

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Vancouver General Hospital

    RECRUITING

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Vseobecna fakultni nemocnice v Praze

    RECRUITING

    Prague, 12808, Czechia

  • Weill Cornell Medical College

    RECRUITING

    New York, New York, 10065, United States

  • Winship Cancer Institute, Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

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

    RECRUITING

    Lodz, Łódź Voivodeship, 93-513, Poland

  • Yamagata University Hospital

    RECRUITING

    Yamagata, 990-9585, Japan

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