Drugs / Teclistamab
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Teclistamab

also known as Tec · BCMAxCD3 · JNJ-64007957 · Teclistamab cqyv · Tecvayli

Monoclonal antibody targets TNFRSF17

Developed for
plasma cell myeloma · AL amyloidosis · hematopoietic and lymphoid cell neoplasm · refractory plasma cell neoplasm · plasma cell leukemia · anti-HLA hyperimmunization · blood group incompatibility · disease related to solid organ transplantation
+4 more · interstitial lung disease · plasmablastic lymphoma · refractory malignant neoplasm · smoldering plasma cell myeloma
Investigated by
Janssen Research & Development, LLC · Johnson & Johnson · National Cancer Institute (NCI) · European Myeloma Network B.V. · Janssen Pharmaceutica · Janssen Pharmaceutica N.V., Belgium
+39 more · Janssen Scientific Affairs, LLC · Memorial Sloan Kettering Cancer Center · PETHEMA Foundation · Peking Union Medical College Hospital · University of Heidelberg Medical Center · West China Hospital · Anne Louise Tølbøll Sørensen · Assistance Publique - Hôpitaux de Paris · Blood Cancer UK · Bristol-Myers Squibb · Cancer Research UK · Carl Ola Landgren, MD, PhD · Christopher Strouse · Deutsche Studiengruppe Multiples Myelom (DSMM) · EMN Trial Office S.r.l. Impresa Sociale · GIMEMA Foundation · HOVON - Dutch Haemato-Oncology Association · Hospital Universitario Dr. Jose E. Gonzalez · Irene Ghobrial, MD · Janssen Pharmaceutical K.K. · Janssen Pharmaceuticals · Janssen, LP · Johnson & Johnson Private Limited · Multiple Myeloma Research Consortium · Nantes University Hospital · Noffar Bar · Nordic Myeloma Study Group · North Estonia Medical Centre · Peking University People's Hospital · Rajshekhar Chakraborty, MD · SCRI Development Innovations, LLC · Sarah Cannon · Shanghai Zhongshan Hospital · University Health Network, Toronto · University Hospital, Lille · University of Alabama at Birmingham · University of Arkansas · University of Leeds · coMMit, Myeloma Trials, Innovated

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved · conditional EU (EMA) Tecvayli 2022-08-23 europa.eu

Trials 52 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07706205 Sep 2026 → Dec 2027 expected blood group incompatibility West China Hospital Not yet recruiting No outcome recorded
Phase 18 trials
Phase 1 NCT07332507 Mar → Dec 2027 expected plasmablastic lymphoma National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 1 NCT07581704 Jun 2026 → Jun 2029 expected plasma cell myeloma Christopher Strouse Recruiting No outcome recorded
Phase 1 NCT07105059 Aug 2025 → Aug 2028 expected plasma cell myeloma Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 1 NCT06425991 Jun 2024 → Jun 2025 overdue plasma cell myeloma Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 1 NCT05338775 May 2022 → May 2025 overdue refractory plasma cell neoplasm Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 1 NCT04722146 Mar 2021 → Oct 2025 overdue plasma cell myeloma Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 1 NCT04108195 Feb 2020 → Apr 2027 expected plasma cell myeloma Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 1 NCT03145181 May 2017 → Sep 2025 overdue hematopoietic and lymphoid cell neoplasm Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT07463807 Jul → Aug 2026 overdue plasma cell myeloma National Cancer Institute (NCI) Not yet recruiting No outcome recorded
Phase 1/2 NCT07099391 Jul 2025 → Jul 2029 expected plasma cell myeloma Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 1/2 NCT04696809 Feb 2021 → Apr 2026 hematopoietic and lymphoid cell neoplasm Janssen Pharmaceutical K.K. Completed No outcome recorded
Phase 1/2 NCT04586426 Dec 2020 → Mar 2025 overdue plasma cell myeloma Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 225 trials
Phase 2 NCT07631208 Oct 2026 → Jan 2027 expected interstitial lung disease Assistance Publique - Hôpitaux de Paris Not yet recruiting No outcome recorded
Phase 2 NCT06948084 Aug 2026 → Feb 2028 expected plasma cell myeloma National Cancer Institute (NCI) Not yet recruiting No outcome recorded
Phase 2 NCT07605416 Jul 2026 → Nov 2032 expected plasma cell leukemia National Cancer Institute (NCI) Not yet recruiting No outcome recorded
Phase 2 NCT07029776 Jul 2026 → Apr 2030 expected plasma cell myeloma University of Arkansas Not yet recruiting No outcome recorded
Phase 2 NCT07638683 May 2026 → Jul 2028 expected AL amyloidosis, plasma cell myeloma Shanghai Zhongshan Hospital Recruiting No outcome recorded
Phase 2 NCT07107529 Dec 2025 → Apr 2029 expected plasma cell myeloma European Myeloma Network B.V. Recruiting No outcome recorded
Phase 2 NCT07110844 Nov 2025 → Oct 2031 expected AL amyloidosis Rajshekhar Chakraborty, MD Recruiting No outcome recorded
Phase 2 NCT06880601 Nov 2025 → Nov 2029 expected plasma cell myeloma GIMEMA Foundation Not yet recruiting No outcome recorded
Phase 2 NCT06993675 Aug 2025 → Aug 2029 expected plasma cell myeloma Noffar Bar Recruiting No outcome recorded
Phase 2 NCT06649695 Jul 2025 → Sep 2028 expected AL amyloidosis European Myeloma Network B.V. Active not recruiting No outcome recorded
Phase 37 trials
Phase 3 NCT07649525 Jul 2026 → Jun 2033 expected plasma cell leukemia, plasma cell myeloma University of Leeds Recruiting No outcome recorded
Phase 3 NCT07671287 Jun 2026 → Feb 2031 expected plasma cell myeloma University of Heidelberg Medical Center Not yet recruiting No outcome recorded
Phase 3 NCT06208150 Jan 2024 → Apr 2026 overdue plasma cell myeloma Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 3 NCT05572515 Mar 2023 → Oct 2025 overdue refractory plasma cell neoplasm Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 3 NCT05552222 Oct 2022 → Apr 2031 expected plasma cell myeloma Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 3 NCT05243797 Sep 2022 → Apr 2028 expected plasma cell myeloma European Myeloma Network B.V. Recruiting No outcome recorded
Phase 3 NCT05083169 Oct 2021 → Dec 2028 expected plasma cell myeloma Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 44 trials
Phase 4 NCT07474961 Mar 2027 → Dec 2036 expected Waldenstrom macroglobulinemia, plasma cell myeloma Anne Louise Tølbøll Sørensen Not yet recruiting No outcome recorded
Phase 4 NCT07689149 Jun 2026 → Dec 2029 expected anti-HLA hyperimmunization, disease related to solid organ transplantation West China Hospital Not yet recruiting No outcome recorded
Phase 4 NCT07030517 May 2025 → Nov 2026 expected plasma cell myeloma Johnson & Johnson Private Limited Recruiting No outcome recorded
Phase 4 NCT06251076 Nov 2024 → Jun 2026 overdue plasma cell myeloma, refractory malignant neoplasm University Health Network, Toronto Recruiting No outcome recorded
Phase not applicable1 trial
NCT06699394 Mar → Dec 2025 overdue AL amyloidosis Peking University People's Hospital Recruiting No outcome recorded
Phase not stated2 trials
NCT05463939 refractory plasma cell neoplasm Janssen Research & Development, LLC Approved for marketing No outcome recorded
NCT05161598 plasma cell myeloma Janssen Research & Development, LLC No longer available No outcome recorded
Also used as a comparator or background therapy in 7 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT06588660 Background Dec 2024 → Feb 2025 plasma cell myeloma University of Washington Terminated No outcome recorded
Phase 1 NCT06465316 Background Dec 2024 → Dec 2026 expected plasma cell myeloma National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT04068597 Background Aug 2019 → Mar 2027 expected T-cell non-Hodgkin lymphoma, acute myeloid leukemia, myelodysplastic syndrome, plasma cell myeloma CellCentric Ltd. Recruiting No outcome recorded
Phase 22 trials
Phase 2 NCT07657312 Background Aug 2026 → Dec 2027 expected cytokine release syndrome, plasma cell myeloma Naresh Bumma Recruiting No outcome recorded
Phase 2 NCT06352866 Background Jan → Apr 2025 cytokine release syndrome, plasma cell myeloma Jack Khouri, MD Withdrawn No outcome recorded
Phase 32 trials
Phase 3 NCT07518186 Comparator May 2026 → Apr 2029 expected plasma cell myeloma Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 3 NCT07258511 Comparator Feb 2026 → Dec 2028 expected plasma cell myeloma Janssen Research & Development, LLC Recruiting No outcome recorded

Press releases naming this drug 6 releases

DateIssuerRelease
2025-06-23 Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka Obtains Exclusive License from Harbour BioMed for HBM7020: A Novel BCMAxCD3 Bispecific T-Cell Engager otsuka.co.jp
2023-05-25 Regeneron Pharmaceuticals Updated Linvoseltamab (BCMAxCD3) Data from Pivotal Trial Demonstrates Early, Deep and Durable Responses in Patients with Heavily Pre-treated Multiple Myeloma regeneron.com
2021-12-11 Regeneron Pharmaceuticals New REGN5458 (BCMAxCD3) Phase 1 Data Show 75% Response Rate at Highest Dose Levels Studied in Patients with Heavily Pretreated Multiple Myeloma regeneron.com
2020-12-05 Regeneron Pharmaceuticals Regeneron's BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1 regeneron.com
2019-12-08 Regeneron Pharmaceuticals First Clinical Data for REGN5458 (BCMAxCD3) Show Positive Preliminary Results in Multiple Myeloma regeneron.com
2019-11-06 Regeneron Pharmaceuticals Regeneron to Report Results from CD20xCD3 and BCMAxCD3 Bispecifics and C5 Antibody Programs at ASH Annual meeting regeneron.com

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 62 sources stand behind the page.

FieldValueCited text
Known as Teclistamab “The purpose of this study is to find out whether Tec-RVd (teclistamab, lenalidomide, bortezomib, and dexamethasone) after 3 treatment Cycles of Dara-RVd (daratumumab,...” NCT07099391
58

Teclistamab is a BCMA×CD3 bispecific T-cell engager (BiTE) administered via subcutaneous injection.” NCT07689149

“melphalan, teclistamab, darzalex” NCT05231629

NCT04696809

NCT07110844

NCT04557098

NCT07474961

NCT07463807

NCT07029776

NCT07631208

NCT06577025

NCT06935162

NCT07518186

NCT05695508

NCT07079423

NCT05572229

NCT07105059

NCT06880601

NCT05243797

NCT07258511

NCT06649695

NCT07332507

NCT05338775

NCT06588660

NCT07107529

NCT05083169

NCT06505369

NCT06948084

NCT07657312

NCT06758375

NCT07581704

NCT04586426

NCT06699394

NCT04108195

NCT03145181

NCT05161598

NCT07649525

NCT06100237

NCT05552222

NCT06353022

NCT06425991

NCT06465316

NCT05572515

NCT05849610

NCT07706205

NCT06993675

NCT05463939

NCT06251076

NCT07030517

NCT04722146

NCT06208150

NCT07605416

NCT05972135

NCT04068597

NCT07671287

NCT07638683

NCT06352866

NCT05469893

NCT06171685

Known as BCMAxCD3 ChEMBL registry synonym — accepted as the source's own label CHEMBL4594505
Known as JNJ-64007957 ChEMBL registry synonym — accepted as the source's own label CHEMBL4594505
Known as Tec Teclistamab (Tec)” NCT07079423
2

Teclistamab (Tec)” NCT06935162

Teclistamab (Tec)” NCT06699394

Known as Teclistamab cqyv ChEMBL registry synonym — accepted as the source's own label CHEMBL4594505
Known as Tecvayli ChEMBL registry synonym — accepted as the source's own label CHEMBL4594505
Action Deplete “Teclistamab also depleted BCMA+ cells in bone marrow samples from MM patients” PMID 32956453 Sep 2020
Modality Monoclonal antibody “Teclistamab is a B-cell maturation antigen × CD3 bispecific antibody” PMID 41886220 Mar 2026
Route Intravenous “Participants will receive IV infusion of Teclistamab.” NCT03145181
Target TNFRSF17 “Tumor necrosis factor receptor superfamily member 17 binding agent” CHEMBL4594505