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New antibody therapy shows promise for Hard-to-Treat myeloma

NCT ID NCT04557098

Disease control Sponsor: Janssen Research & Development, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 4 times

Summary

This study tests a drug called teclistamab in people with multiple myeloma that has come back or stopped responding to treatment. The drug is a special antibody that helps the body's immune cells find and attack cancer cells. About 194 participants will receive the drug to see how well it shrinks tumors and how long the effect lasts.

What this could mean

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

Active substance
teclistamab (a bispecific antibody that helps immune cells attack myeloma cells)
What this could lead to
If successful, this could offer a new treatment option for people with multiple myeloma that has stopped responding to other therapies.
What could go wrong
This is an early-phase trial with a small number of participants. The drug may not work for everyone, and side effects like immune reactions are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

194 people

The number who actually took part.

Started

Sep 2020

Expected to finish

May 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: - * Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 * Measurable disease: Cohort A and Cohort C: Multiple myeloma must be measurable by central laboratory assessment * A female participant of childbearing potential must have a negative pregnancy test at screening * Willing and able to adhere to the prohibitions and restrictions specified in this protocol * Cohort A: received at least \>=3 prior lines of therapy and previously received a PI, an IMiD and an anti-CD38 monoclonal antibody; Cohort C: received \>= 3 prior lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment (with CART-T cells or an antibody drug conjugate (ADC) Exclusion Criteria: * Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis * The following medical conditions: Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, stroke or seizure less than or equal to (\<=) 6 m, autoimmune disease, uncontrolled systemic infection, cardiac conditions (Myocardial Infarction \<= 6 m, stage III-IV congestive heart failure, etc) * Received any therapy that is targeted to BCMA, with the exception of Cohort C in Part 3 * Prior antitumor therapy, within 21 days (PI or radiotherapy within 14 days, IMiDs within 7 days, Gene modified adoptive cell therapy within 3 months) prior to first dose of study drug * Toxicities from previous anticancer therapies that have not resolved to baseline or to \<= grade 1 (except for alopecia or peripheral neuropathy) * Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication) * Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma (MM) * Myelodysplastic syndrome or active malignancies other than relapsed/refractory multiple myeloma with exceptions are: 1) Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured 2) Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. 3) Noninvasive cervical cancer treated within the last 24 months that is considered completely cured. 4) Localized prostate cancer (N0M0) 5) Breast cancer: Adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. 6) Malignancy that is considered cured with minimal risk of recurrence * Prior allogenic stem cell transplant \<=6 months * Prior autologous stem cell transplant \<=12 weeks * Live, attenuated vaccine within 4 weeks prior to the first dose of teclistamab

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm plasma cell myeloma

As listed by the trial registrant

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

Hematological malignancies

Contacts and locations

Locations

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2, Canada

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127, Italy

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • C.H.U. Hotel Dieu - France

    Nantes, 44093, France

  • CHRU Hôpital Bretonneau

    Tours, 37044, France

  • CHU Poitiers - Hopital la Miletrie

    Poitiers, 86000, France

  • Centre Hospitalier Lyon Sud

    Lyon, 69002, France

  • Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

    Lille, 59000, France

  • City of Hope

    Duarte, California, 91010, United States

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • First affiliated Hospital of Zhejiang University

    Hangzhou, 310003, China

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Haematology Centre, R 51

    Stockholm, SE-141 86, Sweden

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916, Spain

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008, Spain

  • Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects

    New York, New York, 10029, United States

  • Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

    Bologna, 40138, Italy

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • Peking University First Hospital

    Beijing, 100034, China

  • Pôle IUC Oncopole CHU

    Toulouse, 31059, France

  • Royal Marsden Hospital

    Sutton, SM2 5PT, United Kingdom

  • Sahlgrenska University Hospital

    Gothenburg, 413 45, Sweden

  • Shanghai Changzheng Hospital

    Shanghai, 200003, China

  • Shengjing Hospital Of China Medical University

    Shenyang, 110134, China

  • Skane University Hospital

    Lund, 221 85, Sweden

  • Stanford University Medical Center

    Stanford, California, 94305-5623, United States

  • Sun Yat -Sen University Cancer Center

    Guangzhou, 510060, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710004, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 30060, China

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Leipzig

    Leipzig, 04103, Germany

  • Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

    Tübingen, 72076, Germany

  • Universitair Ziekenhuis Gent - UZ GENT

    Ghent, 9000, Belgium

  • Universitaire Ziekenhuizen Leuven

    Leuven, 3000, Belgium

  • Universitatsklinikum Wurzburg

    Würzburg, 97080, Germany

  • University College Hospital

    London, NW1 2PG, United Kingdom

  • University Health Network UHN Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • University Hospital Southampton

    Sothampton, SO16 6YD, United Kingdom

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • VU Medisch Centrum

    Amsterdam, 1081 HV, Netherlands

  • West China Hospital Si Chuan University

    Chengdu, 610041, China

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, 30322, United States

More trials for these conditions

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