Tecvayli (teclistamab-cqyv) / Genmab, J&J - LARVOL DELTA

Dual Targeting of Extramedullary Myeloma with Talquetamab and Teclistamab. (PubMed, N Engl J Med) - P1/2 | "Most patients with drug-resistant, true extramedullary myeloma had a response with talquetamab plus teclistamab. The incidence of adverse events of grade 3 or above was high and was consistent with previous observations for each agent as monotherapy. (Funded by Johnson & Johnson; RedirecTT-1 ClinicalTrials.gov number, NCT04586426.)."

Journal • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Oncology • Plasmacytoma • Xerostomia

Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. (PubMed, N Engl J Med) - P3 | "In patients with multiple myeloma who had received one to three previous lines of therapy, those in the teclistamab-daratumumab group had significantly longer progression-free survival than those in the DPd or DVd group. (Funded by Johnson & Johnson; ClinicalTrials.gov number, NCT05083169.)."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

REALiTEC: a multi-country observational retrospective study of teclistamab in patients with relapsed/refractory multiple myeloma outside of clinical trials. (PubMed, Haematologica) - "Infection rates decreased over time, and immunoglobulin replacement therapy was used in up to 60% of patients. REALiTEC corroborates the efficacy observed in MajesTEC-1, supporting teclistamab as an effective treatment option in heavily pre-treated RRMM patients."

Journal • Retrospective data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia • Oncology

Reversing Transplant Ineligibility With Teclistamab in Ultra-High-Risk Relapsed/Refractory Multiple Myeloma With Extramedullary Disease. (PubMed, Clin Lymphoma Myeloma Leuk) - No abstract available

Journal • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

A phase 2 Study of teclistamab in combination with daratumumab in elderly patients with newly diagnosed multiple myeloma: The IFM2021-01 teclille trial, cohort a (ASH 2025) - P2 | "The IFM2021-01 trial is a phase 2study evaluating the doublets teclistamab-daratumumab (Cohort A) and teclistamab-lenalidomide(Cohort B) in frontline transplant-ineligible patients...Daratumumab SC (1800 mg) was given weekly in Cycles 1–2, every 2 weeks inCycles 3–6, and every 4 weeks thereafter...Conclusions. IFM2021-01 Cohort A demonstrates that an "all-antibody–based" doublet regimen ofteclistamab and daratumumab is highly effective and well-tolerated in elderly patients with NDMM, withdeep responses, high MRD negativity, and a favorable safety profile."

Clinical • Combination therapy • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia

Safety and efficacy of AZD0120, a BCMA/CD19 dual-targeting CAR T-cell therapy, in relapsed/refractory multiple myeloma: Preliminary Results from the DURGA-1 Phase 1b/2 study (ASH 2025) - P1/2 | "Whileadvances such as BCMA-directed CAR T-cell therapy have improved outcomes, challenges persist,including disease relapse, treatment toxicities (CRS, ICANS, and non-ICANS neurotoxicities), and access.AZD0120 (formerly GC012F) is a first-in-class autologous BCMA/CD19 dual-targeting CAR T-cell therapyusing the FasTCAR rapid manufacturing platform that preserves the naive and central memory T-cellphenotypes with marked in vivo proliferative capacity...The median age was 64 y (range 44–78), median pLOT was 4 (range 3–7), 72% were triple-classrefractory, 20% had prior BCMA CAR T-cell therapy, 4% had prior teclistamab, 28% had high-riskcytogenetic features [del(13q), del(17p13), t(4; 14), t(14; 16), amp(1q)], and 8% had extramedullaryplasmacytomas...Median timeto CRS onset (DL1/DL2) was 9 d (range 2–11), with a median duration of 2 d (range 1–4); 12 pts (48%)received tocilizumab for CRS management and 12% received dexamethasone... Preliminary phase 1b results..."

CAR T-Cell Therapy • Clinical • P1/2 data • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Multiple Myeloma • Plasmacytoma

Phase 3 randomized study of teclistamab plus daratumumab versus investigator's choice of daratumumab and dexamethasone with either pomalidomide or Bortezomib (DPd/DVd) in patients (Pts) with relapsed refractory multiple myeloma (RRMM): Results of majestec-3 (ASH 2025) - P3 | " Eligible pts had 1-3 prior LOTs including a PI and lenalidomide (Len; pts with 1 prior LOT must have been Len-refractory) with progressive disease (PD) on or after the last LOT. We demonstrate the clinically remarkable and statistically significant PFS and OS benefits of Tec-Dara vs SoC triplets in RRMM, with 83.4% of Tec-Dara pts alive and progression-free at 3 yrs. Infections with Tec-Dara were well managed with established protocols. This highly effective, off-theshelf, immunotherapy combination represents a new SoC for RRMM as early as first relapse."

Clinical • IO biomarker • Late-breaking abstract • P3 data • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Plasmacytoma

Teclistamab Treatment Followed by Heart Transplantation for Advanced Immunoglobulin Light Chain Amyloid Cardiomyopathy. (PubMed, JACC Case Rep) - "Teclistamab achieved a rapid minimal residual disease-negative complete response within weeks, demonstrating its potential as a fast-acting salvage therapy capable of restoring heart transplant eligibility in advanced cardiac AL amyloidosis."

Journal • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders • Transplantation

IMMUNOTHERAPY UNDER THE MICROSCOPE: CARDIO-RENAL OUTCOMES OF CHIMERIC ANTIGEN RECEPTOR T-CELL THERAPY (CART) VS BISPECIFICS IN A REAL-WORLD PROPENSITY-MATCHED COHORT STUDY (ACC 2026) - "Background: No current large studies directly compare cardiac outcomes of bispecific antibodies (Teclistamab, Elranatamab, Talquetamab, Blinatumomab, Epcoritamab, Mosunetuzumab) and CAR T-cell therapies. CART therapy was associated with lower all-cause mortality and fewer cardiac and renal adverse events compared to bispecific antibodies, supporting its potential cardio-oncology safety advantage. Further prospective studies are warranted to validate these findings."

Bispecific • CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • Cardiovascular

Optec/Optal: A Phase 2 Study to Evaluate Outpatient (OP) Step-Up Administration of Teclistamab (Tec) or Talquetamab (Tal) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (SOHO 2025) - "In a separate MajesTEC-1 cohort, patients were administered prophylactic tocilizumab (prophyToci) and experienced less CRS (26%) with no negative impact on efficacy or infections. Administering prophyToci before SUD 1 of Tec reduced the risk of CRS and supports administration of Tec in the OP setting. The protocol was amended to add a Tal cohort. Enrollment is ongoing."

Clinical • P2 data • Hematological Malignancies • Multiple Myeloma • Oncology

Characterization and preclinical efficacy of a CD3×CD20 bispecific T cell engager in a humanized PBMC mouse model (AACR 2026) - "FDA-approved TCEs, such as Epcoritamab (CD3xCD20) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), Blinatumomab (CD3×CD19) for acute lymphoblastic leukemia (ALL) and Teclistamab (CD3×BCMA) for multiple myeloma, have demonstrated significant clinical efficacy in these respective diseases...Furthermore, both low and high doses of TCE resulted in a greater reduction in tumor volume compared to the ICI Toripalimab, a humanized PD-1 monoclonal antibody. Evidence of body weight loss (BWL) was observed in the groups that had PBMCs administered (tumour bearing animals), suggesting that the BWL is linked to the model and PBMC rather that the treatment. These findings highlight the potential of CD3×CD20 TCEs as an alternative strategy for treatment of Burkitt's lymphoma."

Bispecific • Preclinical • Acute Lymphocytic Leukemia • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD20

Phase 2 Study of Talquetamab + Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma and Extramedullary Disease: RedirecTT-1 (EHA 2025) - P1/2 | "With 90 pts with confirmed EMD, the phase 2 cohort of RedirecTT-1 is the largest dedicated EMD study to date. Tal + Tec led to a high ORR and deep, durable responses; efficacy exceeded standard therapies, including BsAb monotherapies, and was comparable to CAR-T therapies in pts with RRMM with EMD. No new safety signals were identified, including no exacerbated Tal or Tec AEs."

Clinical • Late-breaking abstract • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Plasmacytoma • Pneumonia • Respiratory Diseases • Septic Shock

Safety and efficacy of talquetamab + teclistamab in patients with Relapsed/Refractory multiple myeloma from Phase 1b of redirectt-1: Results with an extended median follow-up of 3 years (ASH 2025) - P1/2 | "At an extended mFU of ~3 yrs, Tal + Tec continued to have a safety profile that was generallyconsistent with each monotherapy, with no exacerbation of AEs with the combination. The infectionprofile supported prophylaxis and vigilant monitoring and management. Tal + Tec led to a high ORR anddeep, durable responses in all pts, including at the RP2R and in pts with true EMD, contributing todurable PFS observed across all pts."

Clinical • P1 data • Candidiasis • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Plasmacytoma • HEY1

Interim analysis of LimiTec, a prospective trial of limited-duration teclistamab for relapsed/refractory multiple myeloma (ASH 2025) - P2 | "10/43 (23%) had ≥1 prior BCMA-directed therapies (BCMA-DT) (4 bela-maf, 2cilta-cel, 6 ide-cel)...3/3 pts with PD who received talquetamab (Tal) as next therapyresponded (2 VGPR, 1 CR)... In this preliminary analysis, discontinuation of Tec after 6-9m yields outcomes comparableto historical expectations with continuous therapy with estimated median FFS of 73% at 12m post-discontinuation in a cohort with 23% prior BCMA-DT. Early instances of PD (<6m after Tecdiscontinuation) that were evaluable exhibited BCMA loss and were thus unlikely due to Tecdiscontinuation. Response to Tal immediately after failing Tec re-treatment and low sBCMA at PD furthersuggest resistance due to BCMA loss/mutation as an important mechanism of PD even months after Tecdiscontinuation."

Clinical • IO biomarker • Hematological Malignancies • Multiple Myeloma • SDC1

Single-cell immune profiling reveals enhanced immune fitness of endogenous and engineered T cells in patients with high-risk smoldering myeloma compared to Relapsed/Refractory myeloma following bispecific antibodies or CAR-T cell therapies. (ASH 2025) - P2 | "Indeed,preliminary data from clinical trials of patients with high-risk SMM (HRSMM) have demonstratedunprecedented responses to immunotherapy with Teclistamab (TEC) and Ciltacabtagene autoleucel (cilta)supporting this hypothesis (Nadeem et al, ASH 2023 and 2024). In patients with HRSMM, CAR-T cells exhibit higher stemness,polyclonality, and CD4+ predominance, while TEC-treated T cells show stronger induction of activationand clonal expansion, compared to those with RRMM. In conclusion, these results suggest that thegreater pre-treatment immune capacity in patients with HRSMM favorably shapes immune responses toT cell-redirecting therapies."

CAR T-Cell Therapy • Clinical • IO biomarker • Hematological Malignancies • Multiple Myeloma • Smoldering Multiple Myeloma • CD14 • CD69 • CD8 • CXCR4 • GZMB • HAVCR2 • LAG3 • TBX21 • TCF7 • TIGIT

Efficacy and safety of talquetamab + teclistamab in patients with Relapsed/Refractory multiple myeloma and extramedullary disease: Updated Phase 2 results from the redirectt-1 study with extended follow-up (ASH 2025) - P1/2 | "With longer follow-up in pts with TCE RRMM with true EMD regardless of baseline tumorcharacteristics, Tal + Tec efficacy exceeded all approved therapies, including T-cell redirecting and cellulartherapies, noting limitations of cross-study comparisons. Lower total EMD tumor volume was associatedwith a higher ORR but low pt numbers in each group and lack of statistical testing limits robustinterpretation. The safety profile of Tal + Tec was generally consistent with each monotherapy; AEs werenot exacerbated with the combination."

Clinical • IO biomarker • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Plasmacytoma • Respiratory Diseases

Translational Modeling Predicts Efficacious Therapeutic Dosing Range of Teclistamab for Multiple Myeloma. (PubMed, Target Oncol) - P1 | "Our findings show that PK simulations of early clinical data together with ex vivo cytotoxicity estimates can inform the identification of a bispecific antibody's therapeutic range."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

Elranatamab Versus Teclistamab in Relapsed and Refractory Multiple Myeloma: A Real-World Propensity Score-Matched Study. (PubMed, Target Oncol) - "These findings support individualized treatment selection; prospective comparative trials are warranted."

Journal • Real-world evidence • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia

Targeting BCMA with the T Cell-Engaging Bispecific Antibody Teclistamab in Treatment-Refractory Autoimmune Diseases (EULAR 2026) - No abstract available

Bispecific • Immunology

A CD19/BCMA dual-targeting VHH format T-cell engager with novel CD3 binder for enhanced potency and safety profile (AACR 2026) - "Recently, B cell depletion therapies targeting CD19 or BCMA, including chimeric antigen receptor T-cell (CAR-T) therapies and bispecific antibodies such as Blincyto and Tecvayli, have shown great potential in treating systemic lupus erythematosus (SLE) and other autoimmune diseases (AID). FPE024 induces relatively similar B-cell killing in PBMC from healthy volunteers and SLE patients. In conclusion, FPE024 is a highly potent, CD19/BCMA dual-targeting TCE with preclinical data providing a strong rationale for broad development in AID which benefits from B cell depletion."

Clinical • IO biomarker • Oncology • CD19

Development of a novel anti-CD19 x BCMA dual targeted T cell engager for the treatment of autoimmune diseases and B cell malignancies (AACR 2026) - "In vivo, HXN-1031 demonstrated superior efficacy to Blinatumomab against CD19⁺ tumors, and significantly suppressed BCMA⁺ tumor growth, matching Teclistamab analogue efficacy. In non-human primates, HXN-1031 potently depleted, both in peripheral and bone marrow, B cells and plasma cells, leading to significantly reduced serum immunoglobulin, for a prolonged period of times.Conclusion HXN-1031 is an innovative TCE with finely tuned activity, designed to reset immune system by simultaneously depleting pathogenic B cells and plasma cells. It holds great potential in the treatment of various B cell and plasma cell related autoimmune diseases and malignancies."

Hematological Malignancies • Oncology

BCMA targeted T-cell engager Teclistamab as rescue therapy for severe refractory Autoimmunediseases (EULAR 2026) - No abstract available

Immunology

Safety and Efficacy of the BCMAxCD3 bispecific T cell Engager Teclistamab in Severe Diffuse Cutaneous Systemic Sclerosis (EULAR 2026) - No abstract available

Bispecific • Clinical • Immunology • Scleroderma • Systemic Sclerosis

Characterizing the risk of infections with T-cell engagers in multiple myeloma (AACR 2026) - "Here, we report our experience with infectious complications in relapsed/refractory MM pts receiving TCEs, characterizing their incidence, severity and risk factors. This is a single-center retrospective study of 79 consecutive MM pts who received teclistamab (Tec), elranatamab (Elra) or talquetemab (Talq) between 1/2023-9/2025. In this single-center analysis of heavily pretreated MM pts receiving TCEs, infectious complications were frequent, occurring in 61% pts. Infections were independently associated with inferior OS, while use of IVIG was associated with a 72% reduction in risk of death. Prospective studies are required to establish optimal timing and use of IVIG to demonstrate its efficacy in pts receiving TCEs."

Hematological Malignancies • Multiple Myeloma • Oncology

Myeloma cells with therapy-induced senescence-like phenotype have increased resistance to killing by T cell directed therapies (AACR 2026) - P2 | "Background: Therapy-induced senescence (TIS), a tumor cell state associated with distinct gene expression patterns and implicated in therapy resistance, may be activated in Multiple Myeloma (MM) patients (pt) by genotoxic chemotherapies, such as high-dose melphalan (HDM)...H929VEH or H929HDM were co-cultured with CNTRL T cells with or without teclistamab (Tec, 10 nM) or with day 14 PBMCs from MM pts post-CAR-T (E:T 5:1)... Late-stage MM cells exhibit transcriptional signatures consistent with TIS, which can be associated with decreased PFS to CAR-T. We report an in vitro model of TIS MM cells for testing of resistance to T cell killing. Based on these findings, a phase II trial (NCT06940297) is underway to test the hypothesis that peri-CAR-T senolytic therapy with dasatinib and quercetin will deepen responses by targeting this resistant TIS MM population."

IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • CD14 • CDKN2A • CEBPA • CNTRL • GPNMB • KLRG1 • NDUFA2 • TET2