Abecma (idecabtagene vicleucel) / BMS - LARVOL DELTA

Can baseline Cytomegalovirus IgG titers predict Cytomegalovirus reactivation after ide-cel therapy? (PubMed, Blood Adv) - No abstract available

Journal • Cytomegalovirus Infection

Cilta-cel salvages ide-cel failure in relapsed multiple myeloma by driving distinct immune responses. (PubMed, medRxiv) - "Our results present important clinical evidence that cilta-cel can serve as an effective salvage treatment following ide-cel failure. By providing a direct patient-matched comparison between two CAR therapies, our study uncovers important insights into both CAR T-cell intrinsic properties and immune environmental factors that contribute to effective BCMA CAR T-cell treatment."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology • CD4 • CD8 • IL2

Chimeric antigen receptor T-cell therapy for multiple myeloma. (PubMed, Curr Opin Oncol) - "This is an exciting area with countless studies investigating novel CAR T constructs and sequencing in hopes of further extending and improving our patients' lives."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology • Smoldering Multiple Myeloma

Distinct patient, tumour and chimeric antigen receptor T-cell characteristics are associated with initiating versus sustaining responses to idecabtagene vicleucel in relapsed and refractory multiple myeloma. (PubMed, Br J Haematol) - P2 | "Duration of response was associated with tumour genomic features and quality of engraftment indicated by more robust CD4+ CAR T-cell expansion, higher levels of persistent ide-cel and sustained suppression of BCMA-expressing cells. A working model is proposed whereby patient and microenvironment features that may modulate ide-cel activation and expansion influence the probability of response initiation, and that tumour-intrinsic resistance features and sustained engraftment of ide-cel influence the durability of responses."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology • CD4

Multiple Myeloma Unpacked (ICML 2025) - P3 | "Several other phase II studies have explored the efficacy of triplet regimens incorporating Rd as a backbone, combined with agents such as elotuzumab [30], ixazomib [31], or carfilzomib [32] as well as quadruplet regimen including daratumumab and carfilzomib [33]...The landscape of induction treatment has evolved with the incorporation of the anti-CD38 monoclonal antibody daratumumab (D) into the triplet bortezomib-thalidomide-dexamethasone (VTd) and, more recently, bortezomib-lenalidomide-dexamethasone (VRd)...In transplant-ineligible patients, VRd [45], daratumumab-lenalidomide-dexamethasone (DRd) [46, 47] and daratumumab-bortezomib-melphalan-prednisone (DVMP) [48, 49] have been the standards of cares for years...The FDA approval of isatuximab-bortezomib-lenalidomide-dexamethasone (Isa-VRd), based on the results of the IMROZ study [38], which demonstrated the superiority of Isa-VRd over VRd in terms of MRD negativity and PFS, introduces a new SoC...Consequently,..."

IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • Plasmacytoma • Smoldering Multiple Myeloma • B2M • CRBN • CTCs • XPO1

Sequential BCMA CAR-T Cell Therapy in Refractory Multiple Myeloma. (PubMed, Blood Adv) - "We analyzed 10 heavily pretreated MM patients at three medical centers treated with the commercially approved CAR-T product ide-cel in a real-world setting. Upon relapse, all patients received cilta-cel as a second CAR-T infusion, with bridging treatments permitted between both therapies...Two of three relapsing patients died within a year and showed no further response to bispecific antibody treatment. This study provides the first real-world evidence that sequential treatment with two different commercially approved BCMA CAR-T products is both feasible and effective, particularly in patients with prolonged responses to initial BCMA CAR-T therapy."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

Characterizing Cellular Expansion of Idecabtagene Vicleucel and Association with Clinical Efficacy and Safety in Patients with Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma. (PubMed, J Clin Pharmacol) - P3 | "The multivariable E-R regression models suggest positive relationships between cellular expansion and clinical efficacy and safety endpoints, with higher exposure associated with longer PFS, higher ORR, and higher rates of cytokine release syndrome requiring tocilizumab or corticosteroids. The positive exposure-response relationships were found to be overall similar between KarMMa-3 and a previous study KarMMa. The modeling analyses, paired with clinical data, support extending the dose range from previously approved 300-460 × 106 CAR+ T cells to 300-510 × 106 CAR+ T cells for TCE RRMM patients."

Journal • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

Real-world data provide a CARbon copy for ide-cel. (PubMed, Blood) - No abstract available

Journal • Real-world evidence

Revolutions at the frontline of multiple myeloma treatment: lessons and challenges to finding a cure. (PubMed, Front Oncol) - "Idecabtagene vicleucel and ciltacabtagene autoleucel are chimeric antigen receptor (CAR) T-cell immunotherapies that attach to the extracellular domain of the B-cell maturation antigen (BCMA) and have demonstrated significant response rates in heavily-treated patients. Agents that target BCMA and G protein-coupled receptor class C group 5 member D (GPRC5D) demonstrate impressive clinical responses, while early-phase trials targeting FcRH5 are promising. Here, we provide a comprehensive overview of their individual efficacy, adverse effects, and limitations that impact broader application."

Journal • Review • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor

Immune correlates of anti-BCMA CAR-T products idecabtagene vicleucel and ciltacabtagene autoleucel in a real-world cohort of patients with multiple myeloma. (PubMed, Nat Commun) - "This in-depth biomonitoring report following real-world cilta-cel or ide-cel highlights intrinsic biological differences between BCMA-targeting CAR T products, potentially explaining differences in clinical activity and toxicity. Our findings may guide optimization of cellular immunotherapy strategies in MM."

IO biomarker • Journal • Real-world evidence • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • CD27 • CD4 • HAVCR2

Current Anti-Myeloma Chimeric Antigen Receptor-T Cells: Novel Targets and Methods. (PubMed, Balkan Med J) - "In 2021, idecabtagene vicleucel, a BCMA-targeting agent, became the first CAR-T therapy approved for relapsed/refractory MM, marking a significant milestone in MM treatment. Subsequently, ciltacabtagene autoleucel has also been approved...To address these challenges, strategies such as BCMA non-targeted or dual-targeted CAR-T, memory T cells, humanized CAR-T, and rapidly manufactured PHE885 cells have been developed...In conclusion, studies are exploring the use of CAR-T at an earlier stage, including at diagnosis, with an aim to replace ASCT. CAR-T has introduced a new dimension to MM treatment; however, limited efficacy in high-risk MM and the emergence of resistance to CAR-T remain key challenges to be addressed."

Journal • Review • Gene Therapies • Hematological Malignancies • Multiple Myeloma • Oncology • CD70 • CTAG1B • NCAM1 • SDC1

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies (FDA) - "A REMS is a safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. Because of the risks of cytokine release syndrome (CRS) and neurological toxicities, since their initial approvals until June 2025, the following currently approved (listed alphabetically by trade name) BCMA- or CD19-directed autologous CAR T cell immunotherapies were available through a restricted program under a REMS: Abecma (idecabtagene vicleucel), Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel), Yescarta (axicabtagene ciloleucel)."

FDA event • Oncology

Venous thromboembolism among cancer patients receiving chimeric antigen receptor-T cell therapy. (ASCO 2025) - "Eligibility included administration of any one of the six CAR-T therapies (Tisagenlecleucel, Axicabtagene (Axi-cel), Brexucabtagene, Lisocabtagene, Idecabtagene and Ciltacabtagene) at age ≥18y...The use of glucocorticoids (95% vs 77%, P<0.0001), alkylating agents (91% vs 71%, P<0.0001) or lenalidomide (18% vs 11%, P=0.0006) were significantly associated with VTE... There is 10% incidence of VTE within three months of CAR-T therapy. Particularly, VTE incidence is higher with Axi-cel, and DLBCL diagnosis. Patients with high –risk associations may benefit from thromboprophylaxis regimens, particularly during initial three months of CAR-T therapy."

CAR T-Cell Therapy • Clinical • B Cell Lymphoma • Cardiovascular • Diffuse Large B Cell Lymphoma • Dyslipidemia • Genetic Disorders • Hematological Malignancies • Hypertension • Ischemic stroke • Lymphoma • Mantle Cell Lymphoma • Nicotine Addiction • Non-Hodgkin’s Lymphoma • Obesity • Oncology • Respiratory Diseases • Venous Thromboembolism

MANAGEMENT OF IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME FOLLOWING CAR-T CELL THERAPY IN CLINICAL PRACTICE: A MULTICENTRIC, RETROSPECTIVE, REAL-WORLD ANALYSIS OF TREATMENT APPROACHES AND OUTCOMES (EHA 2025) - "The CAR T-cell products used were Axi-cel in 65 patients (62.5%), Brexu-cel in 15 (14.4%), Tisa-cel in 13 (12.5%), Liso-cel in 5 (4.8%), Ide-cel in 5 (4.8%), and Cilta-cel in 1 (1.0%)...Additionally, delayed initiation of corticosteroids and anakinra were strong determinants of extended ICANS duration (p5 days) was associated with inferior PFS. Early initiation of corticosteroids and IL-1 receptor antagonists was associated with shorter ICANS duration, suggesting that prompt intervention may mitigate prolonged neurotoxicity."

CAR T-Cell Therapy • Real-world • Real-world evidence • Retrospective data • Acute Lymphocytic Leukemia • B Cell Lymphoma • CNS Disorders • Epilepsy • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Incidence and risk factors for venous thromboembolism after CAR T-cell therapy: A systematic review and meta-analysis. (ASCO 2025) - "Following PRISMA guidelines, we searched Medline, Embase, and CENTRAL (Cochrane Central Register of Controlled Trials) through January 1, 2024, for studies enrolling >20 adults treated with any FDA-approved CAR T-cell product (axicabtagene ciloleucel, tisagenlecleucel, brexucabtagene autoleucel, lisocabtagene maraleucel, idecabtagene vicleucel, or ciltacabtagene autoleucel) that reported VTE events (pulmonary embolism, deep vein thrombosis, cerebral vein thrombosis, hepatic vein thrombosis, splenic vein thrombosis, or portal vein thrombosis) post infusion. Approximately 6–8% of patients develop VTE after CAR T-cell therapy, with higher risk among those who have grade >2 CRS, ICANS, or ECOG >1. Given CAR T's expanding role, these findings underscore the need for vigilant VTE assessment and management. Future investigations should evaluate prophylactic anticoagulation strategies to reduce VTE risk in this setting."

CAR T-Cell Therapy • Retrospective data • Review • Cardiovascular • Hematological Malignancies • Ischemic stroke • Oncology • Respiratory Diseases • Solid Tumor • Venous Thromboembolism

U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels (Businesswire) - "Bristol Myers Squibb...announced that the U.S. Food and Drug Administration (FDA) has approved label updates for both of its CAR T cell therapies, Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of large B cell lymphoma (LBCL) and other lymphomas and Abecma (idecabtagene vicleucel; ide-cel) for the treatment of multiple myeloma. These label updates reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs that had been in place since each product was initially approved....The changes include: Driving restrictions reduced from 8 weeks to 2 weeks post treatment; Requirement to stay within proximity of a healthcare facility following infusion reduced from 4 weeks to 2 weeks....The FDA has also approved removal of the REMS requirement from each product label."

FDA event • Large B Cell Lymphoma • Multiple Myeloma

Low platelet counts and low CD4/CD8 ratios at apheresis increase the risk of CAR T-cell manufacturing failure in myeloma. (PubMed, Blood Neoplasia) - "To identify risk factors for CAR-T manufacturing failure in patients with myeloma, a nationwide cohort study was performed, analyzing patients who underwent apheresis for idecabtagene vicleucel in Japan...Manufacturing failure remains an obstacle to CAR-T therapy for patients with myeloma. Avoiding risk factors, such as alkylating agents, and adopting risk-adapted strategies may optimize CAR-T therapy for patients with myeloma."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology • Thrombocytopenia • CD4 • CD8

EFFICACY AND TOXICITY OF RADIATION THERAPY PRIOR TO CHIMERIC ANTIGEN RECEPTOR T-CELL THERAPY IN RELAPSED/REFRACTORY MULTIPLE MYELOMA (ICML 2025) - "26 (51%) received cilta-cel and 25 (49%) received ide-cel. This is one of few studies comparing outcomes, toxicities, and patterns of failure between CT versus CT+RT prior to CAR-T in RRMM. We confirm that there were no differences in toxicity nor efficacy, supporting further investigation of RT as a bridging tool. Relapses were enriched in sites with extramedullary disease, highlighting the challenge of potentiating T-cell infiltration in plasmacytomas."

CAR T-Cell Therapy • Clinical • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology • Plasmacytoma

Extramedullary disease is associated with severe toxicities following B-cell maturation antigen CAR T-cell therapy in multiple myeloma. (PubMed, Haematologica) - "Extramedullary disease (EMD) in multiple myeloma (MM) is associated with poor outcomes following B-cell maturation antigen (BCMA)-targeted CAR-T therapy, yet its impact on treatment-related toxicity remains unclear...We conducted a retrospective cohort study of all patients with MM who received ide-cel (n=32) or cilta-cel (n=76) as standard-of-care therapy at our institution from August 2021 to October 2024...Among 108 patients, 26 (24%) had EMD. Patients with EMD experienced higher rates of grade (G)1+ (38% vs. 17%, p=0.022) and G3+ ICANS (19% vs. 1.2%, p=0.003), as well as G1+ (96% vs. 78%, p=0.041) and G3+ eICAHT (31% vs. 0%, p."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

REAL-WORLD DATA ON BRIDGING STRATEGIES, TOXICITY AND OUTCOMES OF RELAPSED/REFRACTORY MULTIPLE MYELOMA PATIENTS TREATED WITH CAR-T-CELLS (EHA 2025) - "Our results demonstrate the importance of TB reduction by tailored BT, including polychemotherapy regimes and targeted therapies prior to CAR-T. This translates to very high ORR to both ide-cel and cilta-cel and low NRM. We observed significant reduction of CAR-T toxicities depending on the depth of response to BT."

CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma • Oncology

INNOVATIVE SDAB-BASED CAR-T CELLS TARGETING BCMA OUTPERFORM CURRENT CAR-T THERAPIES FOR MULTIPLE MYELOMA (EHA 2025) - "Despite the high remission rates achieved with B-Cell Maturation Antigen (BCMA) CAR-T therapy, long-term responses remain limited, with median progression-free survival (PFS) of 13.8 months for ide-cel and 34.9 months for cilta-cel. In conclusion, we successfully identified and characterized multiple sdAb-based CAR-T cells with distinct affinities, demonstrating their potential to surpass the antitumor efficacy of currently approved MM CAR-T therapies. These findings highlight the promise of sdAb-based CAR-T cells as a novel and effective treatment for MM, paving the way for further clinical development and potential therapeutic application in relapsed or refractory patients."

CAR T-Cell Therapy • IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • HAVCR2 • IFNG • IL2 • LAG3 • PD-1

ASSOCIATION BETWEEN BASELINE PATIENT-REPORTED OUTCOMES AND CLINICAL OUTCOMES OF CHIMERIC ANTIGEN RECEPTOR (CAR) T-CELL THERAPY (EHA 2025) - "The most frequently used CAR-T products were tisagenleccel (34%), followed by lisocabtagene maraleucel (16%), axicabtagene ciloleucel (13%), and idecabtagene vicleucel (12%). Baseline PROs are associated with OS post-CAR-T and risk of CRS and ICANS in CAR-T recipients. These findings underscore the potential utility of pre-CAR-T PROs as important prognostic factors for CAR-T outcomes."

Clinical • Clinical data • Patient reported outcomes • CNS Disorders • Depression • Hematological Malignancies • Lymphoma • Mood Disorders • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Psychiatry

SEQUENTIAL BCMA CAR T-CELL THERAPY IN REFRACTORY MULTIPLE MYELOMA (EHA 2025) - "The first CAR-T was Ide-cel and the second was Cilta-cel in all patients. This study provides the first real-world evidence supporting the feasibility and efficacy of sequential BCMA-directed CAR-T therapy in refractory MM. Our findings indicate that retreatment with BCMA CAR-T cells can elicit meaningful responses, particularly in patients who initially experienced durable responses. These results highlight the potential for sequential CAR-T strategies and provide insights into patient selection for retreatment."

CAR T-Cell Therapy • IO biomarker • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

KarMMa-2: An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma (clinicaltrials.gov) - P2 | N=264 | Active, not recruiting | Sponsor: Celgene | Trial completion date: Dec 2030 ➔ Oct 2025

Trial completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Successful BCMA-CAR T-cell salvage therapy in a patient with idiopathic inflammatory myositis relapsing after CD19-CAR T-cell therapy (EULAR 2025) - "The patient experienced a CMV-viremia under daratumumab, which was successfully treated with oral valganciclovir. Due to ongoing disease activity, plasma cell-targeting BCMA-CAR T-cell therapy was performed (Idecabtagene vicleucel, Bristol Myers Squibb). The patient experienced grade 1 cytokine release syndrome (CRS) on day 3, which resolved upon a single dose of the anti-interleukin-6 receptor monoclonal antibody tocilizumab. No neuro- or hematotoxicity were observed and, supported by a 100-day prophylaxis with letermovir, no CMV-reactivation occurred. BCMA-CAR T-cells expanded, cleared B cells in circulation and plasma cells in lymphoid tissue, reduced autoantibody levels, and re-induced stable drug-free remission with normalization of CK within three months. Learning points for clinical practice: These data demonstrate that (i) a switch of CAR T-cell target can restore drug-free remission after relapse of AID after the first CAR T-cell treatment, (ii) repeated..."

CAR T-Cell Therapy • Clinical • Immunology • Interstitial Lung Disease • Myositis • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Rheumatology • Transplant Rejection • IL6R