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NCT04557098Active, not recruitingPhase 2

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

TECLIMMY1001-P3: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 31 Jul 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
194 (actual)
First submitted
17 Sept 2020
Start date
17 Sept 2020
Primary completion date
9 Nov 2021
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT04557098

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 194
  • From 17 Sept 2020 to the primary completion date, 9 Nov 2021
  • 51 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • 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

Other illness

  • 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)

Other

  • Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma (MM)

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (51)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitair Ziekenhuis Gent (Uz Gent)
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GhentBelgiumUnknown status
Universitaire Ziekenhuizen Leuven
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LeuvenBelgiumUnknown status
Arthur J.E. Child Comprehensive Cancer Centre
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CalgaryCanadaUnknown status
Cross Cancer Institute
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EdmontonCanadaUnknown status
McGill University Health Centre
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MontrealCanadaUnknown status
University Health Network UHN Princess Margaret Cancer Centre
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TorontoCanadaUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
West China Hospital Si Chuan University
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ChengduChinaUnknown status
Sun Yat-sen University Cancer Center
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GuangzhouChinaUnknown status
First Affiliated Hospital of Zhejiang University
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HangzhouChinaUnknown status
Shanghai Changzheng Hospital
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ShanghaiChinaUnknown status
Shengjing Hospital Of China Medical University
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ShenyangChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaUnknown status
The Second Affiliated Hospital of Xi'an Jiaotong University
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Xi'anChinaUnknown status
Universitaetsklinikum Heidelberg
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HeidelbergGermanyUnknown status
Universitaetsklinikum Leipzig
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LeipzigGermanyUnknown status
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
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TübingenGermanyUnknown status
Universitätsklinikum Würzburg
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WürzburgGermanyUnknown status
Hosp. Univ. Germans Trias I Pujol
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BadalonaSpainUnknown status
Hosp Clinic de Barcelona
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BarcelonaSpainUnknown status
Hosp. Univ. 12 de Octubre
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MadridSpainUnknown status
Clinica Univ. de Navarra
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PamplonaSpainUnknown status
Hosp. Quiron Madrid Pozuelo
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Pozuelo de AlarcónSpainUnknown status
Hosp Clinico Univ de Salamanca
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SalamancaSpainUnknown status
Hosp. Univ. Marques de Valdecilla
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SantanderSpainUnknown status
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
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LilleFranceUnknown status
Centre Hospitalier Lyon Sud
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LyonFranceUnknown status
C.H.U. Hotel Dieu - France
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NantesFranceUnknown status
CHU Poitiers - Hôpital la Milétrie
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PoitiersFranceUnknown status
Pôle IUC Oncopole CHU
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ToulouseFranceUnknown status
CHRU - Hôpital Bretonneau
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ToursFranceUnknown status
University College Hospital
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LondonUnited KingdomUnknown status
University Hospital Southampton
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SothamptonUnited KingdomUnknown status
Royal Marsden Hospital
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SuttonUnited KingdomUnknown status
Azienda Ospedaliera Papa Giovanni XXIII
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BergamoItalyUnknown status
Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
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BolognaItalyUnknown status
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyUnknown status
VU Medisch Centrum
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AmsterdamNetherlandsUnknown status
Sahlgrenska University Hospital
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GothenburgSwedenUnknown status
Skåne University Hospital
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LundSwedenUnknown status
Haematology Centre, R 51
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StockholmSwedenUnknown status
Winship Cancer Institute, Emory University
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AtlantaUnited StatesUnknown status
University of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
Levine Cancer Institute
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CharlotteUnited StatesUnknown status
Barbara Ann Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
City of Hope
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DuarteUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
Stanford University Medical Center
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StanfordUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.