Evidence map›Paper›PMID 40332715›Full record

Trial reportTargeted oncology2025

Teclistamab Dosing in Responders: Modeling and Simulation Results from the MajesTEC-1 Study in Relapsed/Refractory Multiple Myeloma.

Yue Guo, Jin Niu, Natalia A Quijano Cardé, Liviawati Wu, Xin Miao, Shalla Hanson, Yaming Su, Carlos Pérez Ruixo, Deeksha Vishwamitra, Katherine Chastain and 3 more

2 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Targeted oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03145181 phase1active not recruitingnot on this map

64007957MMY1001: 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

TypeinterventionalSponsorJanssen Research & Development, LLCRan2017 to 2027Enrolled302ConditionsHematological MalignanciesArmsTeclistamab (IV), Teclistamab(SC)
NCT04557098 phase2active not recruitingnot on this map

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

TypeinterventionalSponsorJanssen Research & Development, LLCRan2020 to 2027Enrolled194ConditionsHematological MalignanciesArmsTeclistamab
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Review
  2. Article
  3. MIDD Evidence to Support Drug Regulatory Decisions in China.Clinical and translational science · 2026
    Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Yue GuoJohnson and Johnson, Spring House, PA, USA. yguo66@its.jnj.com.
Jin NiuJohnson and Johnson, Spring House, PA, USA.
Natalia A Quijano CardéJohnson and Johnson, Spring House, PA, USA.
Liviawati WuJohnson and Johnson, South San Francisco, CA, USA.
Xin MiaoJohnson and Johnson, Spring House, PA, USA.
Shalla HansonJohnson and Johnson, Spring House, PA, USA.
Yaming SuJohnson and Johnson, Raritan, NJ, USA.
Carlos Pérez RuixoJohnson and Johnson, Madrid, Spain.
Deeksha VishwamitraJohnson and Johnson, Spring House, PA, USA.
Katherine ChastainJohnson and Johnson, Raritan, NJ, USA.
Mahesh N SamtaniJohnson and Johnson, Raritan, NJ, USA.
Weirong WangJohnson and Johnson, Spring House, PA, USA.
Nahor Haddish-BerhaneJohnson and Johnson, Spring House, PA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBased on the phase I/II MajesTEC-1 study, the B-cell maturation antigen (BCMA) and cluster of differentiation (CD)3 bispecific antibody, teclistamab, is approved for relapsed/refractory multiple myeloma (RRMM) at a dose of 1.5 mg/kg weekly (QW), with the option to switch to 1.5 mg/kg every other week (Q2W) in patients maintaining complete response (CR) or better for ≥ 6 months on the QW schedule.

objectiveWe report the pharmacokinetics (PK), pharmacodynamics, and anticancer activity of teclistamab 1.5 mg/kg Q2W, and the PK of teclistamab 3 mg/kg every 4 weeks (Q4W), on the basis of modeling and simulation results from MajesTEC-1.

methodsTeclistamab PK was assessed using a population PK approach. Exposure-response analysis was based on individual estimated teclistamab serum trough concentration (C

resultsMedian estimated teclistamab serum C

conclusionsMajesTEC-1 modeling and simulation results, which contributed to the teclistamab label update, support the approved switch to teclistamab 1.5 mg/kg Q2W in patients maintaining ≥ CR for ≥ 6 months on the QW dose, without negatively impacting clinical efficacy. In addition, it is estimated that the 3 mg/kg Q4W schedule will provide maintenance of response comparable with the 1.5 mg/kg Q2W schedule. Teclistamab 3 mg/kg Q4W dosing will be evaluated in > 800 patients in three phase III studies in early line RRMM (MajesTEC-3, MajesTEC-9, and MonumenTAL-6) and in 100 patients in RRMM in the phase I MajesTEC-10 study. CLINICAL

trial registrationNCT03145181 (phase I, 9 May 2017); NCT04557098 (phase II, 21 September 2020).

Indexed as

Antibodies, BispecificMultiple MyelomaAgedComputer SimulationFemaleHumansMaleMiddle AgedAntibodies, Bispecific

Identifiers

PMID40332715
PMCPMC12307566

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.