Evidence map›Paper›PMID 39660861›Full record

Trial reportCancer2025

Efficacy, safety, and pharmacokinetics of teclistamab in Chinese patients with relapsed/refractory multiple myeloma from the China cohort of MajesTEC-1.

Zhen Cai, Zhongjun Xia, Ai-Li He, Yu-Jun Dong, Yafei Wang, Aijun Liao, Yang Song, Juanjuan Song Mm, Clarissa Uhlar, Katherine Chastain and 13 more

2 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer, 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 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
–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

12 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

23 authors.

Zhen CaiFirst Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, Zhejiang, China.ORCID https://orcid.org/0000-0001-6026-3804
Zhongjun XiaSun Yat-Sen University Cancer Center, Guangzhou, China.
Ai-Li HeThe Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Yu-Jun DongPeking University First Hospital, Beijing, China.
Yafei WangTianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Aijun LiaoShengjing Hospital of China Medical University, Shenyang, China.
Yang SongJanssen Research & Development, Beijing, China.
Juanjuan Song MmJanssen Research & Development, Beijing, China.
Clarissa UhlarJanssen Research & Development, Spring House, Pennsylvania, USA.
Katherine ChastainJanssen Research & Development, Raritan, New Jersey, USA.
Latisha WatkinsJanssen Research & Development, Raritan, New Jersey, USA.
Xinchao LuoJanssen Research & Development, Shanghai, China.
Lin HuangJanssen Research & Development, Spring House, Pennsylvania, USA.
Zhuolu NiuJanssen Research & Development, Shanghai, China.
Natalia A Quijano CardéJanssen Research & Development, Spring House, Pennsylvania, USA.
Yue GuoJanssen Research & Development, Spring House, Pennsylvania, USA.
Hongmei XuJanssen Research & Development, Shanghai, China.
Raluca I VeronaJanssen Research & Development, Spring House, Pennsylvania, USA.
Longen ZhouJanssen Research & Development, Shanghai, China.
Jingyun LiJanssen Research & Development, Beijing, China.
Weijun FuMyeloma & Lymphoma Center, Shanghai Changzheng Hospital, Naval Medical University, Shanghai, China.
Ting NiuWest China Hospital, Sichuan University, Chengdu, Sichuan, China.
Juan DuMyeloma & Lymphoma Center, Shanghai Changzheng Hospital, Naval Medical University, Shanghai, China.ORCID https://orcid.org/0000-0003-2538-4007

Funding

Janssen Research and Development
6 · The paper itself

Abstract

introductionTeclistamab, the first approved B-cell maturation antigen-directed bispecific antibody for treatment of triple-class exposed relapsed/refractory multiple myeloma, demonstrated deep, durable responses with a manageable safety profile in the pivotal MajesTEC-1 cohort (NCT03145181/NCT04557098). Efficacy, safety, and pharmacokinetics from the MajesTEC-1 China cohort are reported.

methodsPatients received teclistamab 1.5 mg/kg subcutaneously weekly after step-up dosing; patients could switch to less frequent dosing with continued response.

resultsIn the China cohort (N = 26; median age, 66 years; median prior lines of therapy, 5) 15-month median follow-up, overall response rates, very good partial response or better, and complete response or better (≥CR) were 76.9%, 76.9%, and 57.7%, respectively. Median time to first response and ≥CR were 1.4 and 6.3 months, respectively; among patients with ≥CR and have available MRD samples, MRD negativity was achieved in 14/15 (93.3%) patients. Median duration of response, progression-free survival, and overall survival were not reached; 12-month duration of response, progression-free survival, and overall survival rates were 78.5%, 68.0%, and 83.5%, respectively. The safety profile was consistent with the pivotal cohort. Although infections occurred in 96.2% of patients, incidence decreased over time with six patients experiencing infections for >12 to 18 months. There were no discontinuations because of adverse events and no dose reductions. Ten patients switched to less frequent dosing. Teclistamab serum concentrations were consistent with the pivotal cohort, with a slightly lower mean pharmacokinetics profile.

conclusionsTeclistamab demonstrated efficacy and safety profiles in the China cohort consistent with the pivotal cohort, supporting teclistamab as a promising treatment option for triple-class exposed relapsed/refractory multiple myeloma in China.

Indexed as

Antibodies, BispecificMultiple MyelomaAdultAgedAged, 80 and overB-Cell Maturation AntigenChinaCohort StudiesEast Asian PeopleFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalTreatment OutcomeAntibodies, BispecificB-Cell Maturation Antigenbispecific antibody (BsAb)relapsed/refractory multiple myeloma (RRMM)teclistamabtriple‐class exposed (TCE)

Identifiers

PMID39660861
PMCPMC11694538

What OpenQuestion holds

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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.