Tecvayli

(Teclistamab)

ApprovedMonoclonal antibody

Teclistamab is used to treat multiple myeloma, a type of blood cancer affecting plasma cells in the bone marrow. It works by helping the immune system recognize and attack cancer cells.[2] Tecvayli is currently approved and in use across 17 indications[4].[1]

Tecvayli is one of 202 small molecule programs targeting Recurrent Multiple Myeloma. It is currently in Approved.

Indications

Total Trials

Active Trials

201

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Recurrent Multiple MyelomaRecruiting

Haematological MalignancyRecruiting

Relapsed/refractory Multiple MyelomaActive, not recruiting

Hematological MalignanciesActive, not recruiting

Cytokine Release SyndromeWithdrawn

AmyloidRecruiting

Multiple Myeloma (MM)Recruiting

Plasmablastic LymphomaRecruiting

High-Risk Smoldering Multiple MyelomaRecruiting

Multiple Myeloma ProgressionNot yet recruiting

Recurrent Multiple MyelomaPhase 1

Recruiting

Haematological MalignancyPreclinical

Recruiting

Relapsed/refractory Multiple MyelomaPhase 1

Active, not recruiting

Hematological MalignanciesPhase 2

Active, not recruiting

Cytokine Release SyndromePhase 2

Withdrawn

AmyloidPhase 2

Recruiting

Multiple Myeloma (MM)Phase 3

Recruiting

Plasmablastic LymphomaPhase 1

Recruiting

High-Risk Smoldering Multiple MyelomaPhase 2

Recruiting

Multiple Myeloma ProgressionPhase 2

Not yet recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

282 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

Tecvayli

Johnson & Johnson

Approved

26 2

Belamaf

GSK

Phase 3

39 3

Empliciti

Bristol-Myers Squibb

Phase 3

45 4

TALVEY

Johnson & Johnson

Phase 3

24 5

Xpovio

KKaryopharm Therapeutics Inc

Phase 3

29 6

Vepesid

AAvyxa

Phase 3

17 7

BLENREP

GGlaxo Dba Glaxosmithkline

Phase 3

10 8

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

9 9

Mezigdomide

Etentamig

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Study completion

NCT06251076

Phase 1/2Active, not recruiting

Multiple Myeloma

NCT04586426

N/ARecruiting

AL Amyloidosis

NCT06699394

Phase 1Recruiting

Recurrent Multiple Myeloma

NCT06465316

Q1 2027

ApprovedActive, not recruiting

Multiple Myeloma

NCT07030517

PreclinicalRecruiting

Haematological Malignancy

NCT04068597

Clinical

Trials by Indication[1]

Multiple Myeloma26 trials

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05572515·614 enrolled

Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients

Approved for marketing· Johnson & Johnson logo

Johnson & Johnson··NCT05463939

Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients

Recruiting·—·Phase 2·NCT06505369·50 enrolled

Show 23 more trials

Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.

Not yet recruiting·EEuropean Myeloma Network B.V.·Phase 2·NCT07107529·150 enrolled

ST-067 and Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma

Terminated·UUniversity of Washington·Phase 1·NCT06588660·1 enrolled

Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R/R Multiple Myeloma

Not yet recruiting·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT06880601·52 enrolled

Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma

Active, not recruiting·PPETHEMA Foundation·Phase 2·NCT05849610·30 enrolled

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

Recruiting·EEuropean Myeloma Network B.V.·Phase 3·NCT05243797·1,594 enrolled

Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

Recruiting·SSCRI Development Innovations, LLC·Phase 2·NCT05972135·100 enrolled

Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

Recruiting·UUniversity Hospital, Lille·Phase 2·NCT05572229·74 enrolled

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

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1/2·NCT04696809·40 enrolled

A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1/2·NCT04586426·228 enrolled

Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma

Active, not recruiting·NNantes University Hospital·Phase 2·NCT06353022·103 enrolled

A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Subjects With Multiple Myeloma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04108195·290 enrolled

A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05083169·587 enrolled

A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04722146·140 enrolled

A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Different Sequences of Ciltacabtagene Autoleucel (Cilta-cel), Talquetamab SC in Combination With Daratumumab SC (Tal-D) and Teclistamab SC in Combination With Daratumumab SC (Tec-D) Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Participants With Standard-risk Newly Diagnosed Multiple Myeloma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT06577025·43 enrolled

A Phase 1 Randomized, Open Label Pharmacokinetic Comparability Study Comparing Pre- and Post-change Teclistamab in Participants With Relapsed/Refractory Multiple Myeloma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT06425991·108 enrolled

An Open Label, Multicenter, Phase IV Study of Teclistamab to Evaluate Its Safety in Indian Participants With Relapsed and Refractory Multiple Myeloma Who Have Previously Received at Least 3 Prior Lines of Therapy Including an Immunomodulatory Agent, a Proteasome Inhibitor and an Anti-CD38 Antibody and Have Demonstrated Disease Progression on the Last Therapy

Active, not recruiting·JJohnson & Johnson Private Limited·Approved·NCT07030517·75 enrolled

64407564MMY3009: A Phase 3 Randomized Study Comparing Talquetamab in Combination With Pomalidomide (Tal-P), Talquetamab in Combination With Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pom

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06208150·838 enrolled

A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05552222·1,590 enrolled

A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti CD38 Antibody

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT07258511·400 enrolled

A Phase 3 Randomized Study Comparing JNJ-79635322 Versus Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma After 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT07518186·700 enrolled

Teclistamab and Mezigdomide for Relapsed/Refractory Multiple Myeloma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT07105059·18 enrolled

A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumumab (Tec-Dara) in Newly Diagnosed Multiple Myeloma With Concurrent Light Chain Amyloidosis (MM+AL)

Recruiting·SShanghai Zhongshan Hospital·Phase 2·NCT07638683·30 enrolled

Accelerate Improvement in Multiple Myeloma for Newly Diagnosed Transplant-Eligible Patients

Not yet recruiting·UUniversity of Heidelberg Medical Center·Phase 3·NCT07671287·399 enrolled

AL amyloidosis4 trials

Teclistamab in Previously Treated AL Amyloidosis

Recruiting·PPeking Union Medical College Hospital·Phase 2·NCT06935162·30 enrolled

Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis

Recruiting·PPeking Union Medical College Hospital·Phase 2·NCT07079423·35 enrolled

Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

Recruiting·PPeking University People's Hospital·N/A·NCT06699394·20 enrolled

Show 1 more trial

A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis

Active, not recruiting·EEuropean Myeloma Network B.V.·Phase 2·NCT06649695·30 enrolled

Recurrent Multiple Myeloma3 trials

A Randomized Phase II Trial for High-Risk Multiple Myeloma That is Refractory or in First Relapse With Daratumumab, Teclistamab (DT) Versus Daratumumab, Pomalidomide, Dexamethasone (DPd) or Daratumumab, Carfilzomib, Dexamethasone (DKd)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06948084·80 enrolled

A Phase 1b Trial of Teclistamab in Combination With Iberdomide for Relapsed/Refractory Multiple Myeloma

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT06465316·26 enrolled

Phase Ib/II Fixed Duration Study of Teclistamab/Pomalidomide (TP) Versus Carfilzomib/Pomalidomide/Dexamethasone (KPd) in Early Relapse of Multiple Myeloma

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT07463807·162 enrolled

Multiple Myeloma (MM)3 trials

A Phase 2 Study Exploring the Use of Bispecific Antibodies to Improve Progression Free Survival in Patients With High-Risk Newly Diagnosed Multiple Myeloma (MMulti-Immune HR)

Not yet recruiting·UUniversity of Arkansas·Phase 2·NCT07029776·50 enrolled

Phase 3 Randomized Study of Teclistamab and Talquetamab (Tec-Tal) Versus Daratumumab and Lenalidomide (DR) in Minimal Residual Disease (MRD) Positive Patients With Newly Diagnosed Multiple Myeloma After Autologous Hematopoietic Stem Cell Transplantation (TiTan)

Not yet recruiting·PPolish Myeloma Consortium·Phase 3·NCT07740486·248 enrolled

iFIT (UK-MRA Myeloma XVIII): Immunotherapy Approaches Adapted for Fitness in Newly Diagnosed Transplant Ineligible Patients With Myeloma

Recruiting·UUniversity of Leeds·Phase 3·NCT07649525·1,226 enrolled

Cytokine Release Syndrome2 trials

Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM

Withdrawn·JJack Khouri, MD·Phase 2·NCT06352866

Phase 2 Study of Cytokine Release Syndrome Prophylaxis With Infliximab for Teclistamab/Talquetamab Therapy in Patients With Relapsed/Refractory Myeloma

Recruiting·NNaresh Bumma·Phase 2·NCT07657312·35 enrolled

17 more indications

Hematological Malignancies2 trials

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

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03145181·302 enrolled

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

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04557098·194 enrolled

ESS1 trial

Pre-approval Access Single Patient Request for Teclistamab (JNJ-64007957)

No longer available· Johnson & Johnson logo

Johnson & Johnson··NCT05161598

Efficacy1 trial

Study on the Clinical Efficacy of Teclistamab

Recruiting·UUniversitaire Ziekenhuizen KU Leuven··NCT06477783·100 enrolled

Newly Diagnosed1 trial

Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)

Recruiting·NNoffar Bar·Phase 2·NCT06993675·50 enrolled

Trial1 trial

MMRC Horizon One Adaptive Platform Trial Evaluating Therapies in RRMM

Recruiting·MMultiple Myeloma Research Consortium·Phase 2·NCT06171685·300 enrolled

Daratumumab1 trial

Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the REVIVE Study)

Recruiting·—·Phase 2·NCT06100237·50 enrolled

Plasmablastic Lymphoma1 trial

Phase 1b Study of Teclistamab in Relapsed/Refractory Plasmablastic Lymphoma

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT07332507·30 enrolled

Waldenstrom macroglobulinemia1 trial

A Phase 2 Study of Teclistamab in Relapsed or Refractory Waldenstrom's Macroglobulinemia

Not yet recruiting·MMassachusetts General Hospital·Phase 2·NCT07791498·24 enrolled

Plasma Cell Leukemia1 trial

Quadruplet Induction Followed by Teclistamab Consolidation and Doublet Maintenance in Patients With Primary Plasma Cell Leukemia: The QUANTUM Trial

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07605416·74 enrolled

Relapsed/Refractory Multiple Myeloma1 trial

A Phase 1b Study of Bispecific T Cell Redirection Antibodies in Combination With Checkpoint Inhibition for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05338775·74 enrolled

Multiple Myeloma Progression1 trial

A Phase II, Open-label, Multicenter Study Testing Teclistamab in Combination With Pomalidomide Administered in Alternative Fashion in Participants With RRMM, Who Received 1 - 3 Prior Lines of Therapy, Including Lenalidomide and Anti-CD38 Therapy.

Not yet recruiting·OOdense University Hospital·Phase 2·NCT07757412·50 enrolled

Relapsed or Refractory Multiple Myeloma1 trial

A Phase 3, Multicenter, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etentamig in Combination With Pomalidomide Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (2L+ RRMM)

Not yet recruiting· AbbVie logo

AbbVie·Phase 3·NCT07728188·520 enrolled

Myeloma Multiple1 trial

The Norwegian Immunotherapy in Multiple Myeloma Study - A Population-based Longitudinal Observational Multicenter Study on Effectiveness and Complications of Immunotherapy in Multiple Myeloma in the Norwegian Myeloma Cohort

Recruiting·SSt. Olavs Hospital··NCT06855121·400 enrolled

High-risk Smoldering Multiple Myeloma1 trial

Immuno-PRISM (PRecision Intervention Smoldering Myeloma): A Randomized Phase II Platform Study of Select Immunotherapies for High-Risk Smoldering Myeloma

Recruiting·IIrene Ghobrial, MD·Phase 2·NCT05469893·52 enrolled

Amyloid1 trial

A Phase 2 Clinical Trial of Teclistamab and Daratumumab in Previously Untreated AL Amyloidosis

Recruiting·RRajshekhar Chakraborty, MD·Phase 2·NCT07110844·25 enrolled

Haematological Malignancy1 trial

An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy and in Combination in Patients With Advanced Haematological Malignancies.

Recruiting·CCellCentric Ltd.·Preclinical·NCT04068597·250 enrolled

Unspecified2 trials

GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5

Recruiting·UUniversity of Heidelberg Medical Center·Phase 2·NCT05695508·160 enrolled

Plan Development for Giving Teclistamab in the Outpatient Setting

Recruiting·UUniversity Health Network, Toronto·Phase 4·NCT06251076·15 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 25, 2022

TECVAYLI

NDA BLA761291

Oct 25, 2022

TECVAYLI

BLA BLA761291

Aug 9, 2023

TECVAYLI

NDA BLA761291

Nov 16, 2023

TECVAYLI

NDA BLA761291

Feb 20, 2024

TECVAYLI

NDA BLA761291

May 28, 2024

TECVAYLI

NDA BLA761291

Jul 2, 2024

TECVAYLI

NDA BLA761291

Nov 22, 2024

TECVAYLI

NDA BLA761291

Dec 2, 2024

TECVAYLI

NDA BLA761291

Aug 19, 2025

TECVAYLI

NDA BLA761291

Oct 2, 2025

TECVAYLI

NDA BLA761291

Mar 5, 2026

TECVAYLI

NDA BLA761291

May 6, 2026

TECVAYLI

NDA BLA761291

Sources

References

[1]
ClinicalTrials.gov — 57 trial records for Teclistamab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tecvayli drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Teclistamab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Teclistamab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA761291). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: T Cell Surface Glycoprotein CD3 Binding Agent; Tumor Necrosis Factor Receptor Superfamily Member 17 Binding Agent[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Johnson & Johnson

Tecvayli

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Multiple Myeloma26 trials

AL amyloidosis4 trials

Recurrent Multiple Myeloma3 trials

Multiple Myeloma (MM)3 trials

Cytokine Release Syndrome2 trials

Hematological Malignancies2 trials

ESS1 trial

Efficacy1 trial

Newly Diagnosed1 trial

Trial1 trial

Daratumumab1 trial

Plasmablastic Lymphoma1 trial

Waldenstrom macroglobulinemia1 trial

Plasma Cell Leukemia1 trial

Relapsed/Refractory Multiple Myeloma1 trial

Multiple Myeloma Progression1 trial

Relapsed or Refractory Multiple Myeloma1 trial

Myeloma Multiple1 trial

High-risk Smoldering Multiple Myeloma1 trial

Amyloid1 trial

Haematological Malignancy1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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