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    DRUG:

    Tecvayli (teclistamab-cqyv)

    i
    Other names: JNJ-64007957, JNJ 64007957, JNJ64007957, JNJ 7957, Ab-957, Ab 957, Ab957, JNJ7957
    Company:
    Genmab, J&J
    Drug class:
    CD3 agonist, BCMA inhibitor
    Related drugs:
    2d
    Trilogy-4: A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P3, N=400, Not yet recruiting, Janssen Research & Development, LLC
    New P3 trial
    |
    JNJ-5322 • Tecvayli (teclistamab-cqyv)
    10d
    MajesTEC-9: A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P3, N=614, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    lenalidomide • bortezomib • carfilzomib • pomalidomide • Tecvayli (teclistamab-cqyv)
    29d
    MMulti-Immune HR; Multi-Target Immunotherapy for High-Risk Multiple Myeloma (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, University of Arkansas | Initiation date: Oct 2025 --> Apr 2026
    Trial initiation date
    |
    clonoSEQ
    |
    lenalidomide • Darzalex (daratumumab) • melphalan • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
    1m
    OPTec: Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma (clinicaltrials.gov)
    P2, N=75, Recruiting, SCRI Development Innovations, LLC | Trial completion date: Mar 2026 --> Oct 2027 | Trial primary completion date: Feb 2026 --> Aug 2027
    Trial completion date • Trial primary completion date
    |
    Actemra IV (tocilizumab) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
    1m
    Current progress and latest therapeutic options in immuno-oncology (PubMed, Dtsch Med Wochenschr)
    For solid cancers, these comprise the antibody-drug-conjugate Mirvetuximab Soravtansine for platinum-resistant ovarian cancer, the monoclonal antibody Zolbetuximab for Claudin-18.2 positive gastric adenocarcinoma and the checkpoint inhibitor Tislelizumab for esophageal squamous cell carcinoma. For the treatment of relapsed or refractory hematologic B cell malignancies, the use of bispecific T cell engaging antibodies like the BCMA-CD3 targeting Teclistamab and CD20-CD3 targeting Glofitamab were approved by the EMA recently.Combinatorial approaches of conventional chemotherapy and checkpoint inhibitors for the treatment of cholangiocarcinoma, urothelial carcinoma and endometrial carcinoma received recent approval.A CD38 antibody-based bridging therapy for the treatment of newly diagnosed multiple myeloma and the Glofitamab-based approach in combination with Gemcitabine and Oxaliplatin for relapsed DLBCL are the latest additions for hematologic malignancies after promising clinical trials.The first T cell products for the treatment of solid cancers using either tumor-infiltrating lymphocytes or TCR-engineered peripheral blood T cells were approved by the FDA in 2024, for the treatment of advanced melanoma (Lifileucel) and synovial sarcoma (Afamitresgene autoleucel). To further expand the success of T cell products to solid tumors, promising preclinical studies suggest solutions to main obstacles, such as modular CAR T cells, targeting of two antigens simultaneously or generation of cytokine-secreting 4th generation CAR T cells.
    Review • Journal
    |
    CLDN18 (Claudin 18)
    |
    gemcitabine • Tevimbra (tislelizumab-jsgr) • oxaliplatin • Elahere (mirvetuximab soravtansine-gynx) • Vyloy (zolbetuximab-clzb) • Tecelra (afamitresgene autoleucel) • Tecvayli (teclistamab-cqyv) • Amtagvi (lifileucel) • Columvi (glofitamab-gxbm)
    2ms
    MajesTEC-1: Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=302, Active, not recruiting, Janssen Research & Development, LLC | Phase classification: P1 --> P1/2
    Phase classification • IO biomarker • First-in-human
    |
    Tecvayli (teclistamab-cqyv)
    2ms
    aMMbition: A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma (clinicaltrials.gov)
    P2, N=43, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    lenalidomide • bortezomib • cyclophosphamide • fludarabine IV • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Carvykti (ciltacabtagene autoleucel) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
    2ms
    MajesTEC-3: 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 (clinicaltrials.gov)
    P3, N=587, Active, not recruiting, Janssen Research & Development, LLC | Trial primary completion date: Aug 2025 --> Dec 2028
    Trial primary completion date
    |
    bortezomib • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Tecvayli (teclistamab-cqyv) • dexamethasone injection
    2ms
    MajesTEC-2: A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (clinicaltrials.gov)
    P1, N=140, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Apr 2027 --> Oct 2027
    Trial completion date
    |
    lenalidomide • bortezomib • Darzalex (daratumumab) • pomalidomide • Ogsiveo (nirogacestat) • Tecvayli (teclistamab-cqyv)
    2ms
    MonumenTAL-6: 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 (clinicaltrials.gov)
    P3, N=795, Recruiting, Janssen Research & Development, LLC | Trial completion date: Jun 2027 --> Jan 2028
    Trial completion date
    |
    lenalidomide • bortezomib • pomalidomide • Empliciti (elotuzumab) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv) • dexamethasone injection
    2ms
    TRIMM-2: A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma (clinicaltrials.gov)
    P1, N=290, Active, not recruiting, Janssen Research & Development, LLC | Trial primary completion date: Aug 2025 --> Apr 2027
    Trial primary completion date
    |
    pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
    2ms
    MonumenTAL-6: 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 (clinicaltrials.gov)
    P3, N=795, Recruiting, Janssen Research & Development, LLC | Trial completion date: Jun 2030 --> Jun 2027
    Trial completion date
    |
    lenalidomide • bortezomib • pomalidomide • Empliciti (elotuzumab) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv) • dexamethasone injection