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 12 indications[4].[1]

Tecvayli is one of 161 small molecule programs targeting AL amyloidosis. It is currently in Approved.

Indications

Total Trials

Active Trials

160

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

AL AmyloidosisActive, not recruiting

LymphomaActive, not recruiting

AmyloidosisActive, not recruiting

Hematopoietic and Lymphoid Cell NeoplasmActive, not recruiting

Plasma Cell LeukemiaNot yet recruiting

Multiple MyelomaRecruiting

Relapsed/refractory Multiple MyelomaActive, not recruiting

Hematological MalignanciesActive, not recruiting

Haematological MalignancyRecruiting

Recurrent Multiple MyelomaRecruiting

AL AmyloidosisPhase 2

Active, not recruiting

LymphomaPhase 1

Active, not recruiting

AmyloidosisPhase 2

Active, not recruiting

Hematopoietic and Lymphoid Cell NeoplasmPhase 2

Active, not recruiting

Plasma Cell LeukemiaPhase 2

Not yet recruiting

Multiple MyelomaApproved

Recruiting

Relapsed/refractory Multiple MyelomaPhase 1

Active, not recruiting

Hematological MalignanciesPhase 2

Active, not recruiting

Haematological MalignancyPreclinical

Recruiting

Recurrent Multiple MyelomaPhase 1

Recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Tecvayli

Johnson & Johnson

Approved

1 2

Blenoxane

SSequus Pharmaceuticals

Preclinical

25 3

Zofran

Novartis

Preclinical

2 4

Wellcovorin

GGlaxo Dba Glaxosmithkline

Preclinical

4 5

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 6

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 7

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—8

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

PEG-Intron

1 10

CAR-T

HHebei Senlang Biotechnology Inc., Ltd.

Preclinical

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

Timeline

Expected Milestones

Q3 2026

PreclinicalNot yet recruiting

Recurrent Multiple Myeloma

NCT07463807

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

Phase 1Not yet recruiting

Lymphoma

NCT07332507

Clinical

Trials by Indication[1]

Multiple Myeloma26 trials

Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse

Not yet recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06948084·80 enrolled

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

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

Show 23 more trials

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (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

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

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

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

The Norwegian Immunotherapy in Multiple Myeloma Study

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

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

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

Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

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

Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

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

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

A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma

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

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

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 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 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

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 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

Recruiting·JJohnson & Johnson Private Limited·Approved·NCT07030517·75 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

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 amyloidosis3 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

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

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

Recurrent Multiple Myeloma2 trials

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

Not yet recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT07463807·162 enrolled

14 more indications

ESS1 trial

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

No longer available· Johnson & Johnson logo

Johnson & Johnson··NCT05161598

Trial1 trial

MMRC Horizon One Adaptive Platform Trial Evaluating Therapies in RRMM

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

Efficacy1 trial

Study on the Clinical Efficacy of Teclistamab

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

Myeloma1 trial

Immuno-PRISM (PRecision Intervention Smoldering Myeloma)

Recruiting·—·Phase 2·NCT05469893·52 enrolled

Lymphoma1 trial

Testing the Effect of Teclistamab on Recurrent Plasmablastic Lymphoma

Not yet recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT07332507·30 enrolled

Relapsed or Refractory1 trial

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06208150·795 enrolled

Amyloidosis1 trial

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

Recruiting·EEuropean Myeloma Network B.V.·Phase 2·NCT06649695·30 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

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

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

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

Plasma Cell Leukemia1 trial

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

Not yet recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07605416·74 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

Plan Development for Giving Teclistamab in the Outpatient Setting

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

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

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

Regulatory

FDA Approval Timeline[5]

Oct 25, 2022

TECVAYLI

BLA BLA761291

Sources

References

[1]
ClinicalTrials.gov — 50 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 (BLA 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

Q3 2026

Q4 2026

Q1 2027

Trials by Indication[1]

Multiple Myeloma26 trials

AL amyloidosis3 trials

Cytokine Release Syndrome2 trials

Hematological Malignancies2 trials

Recurrent Multiple Myeloma2 trials

ESS1 trial

Trial1 trial

Efficacy1 trial

Myeloma1 trial

Lymphoma1 trial

Relapsed or Refractory1 trial

Amyloidosis1 trial

Daratumumab1 trial

Newly Diagnosed1 trial

Amyloid1 trial

Relapsed/Refractory Multiple Myeloma1 trial

Plasma Cell Leukemia1 trial

Haematological Malignancy1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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