Abecma (idecabtagene vicleucel) / BMS - LARVOL DELTA

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

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

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

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

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

Remission conversion drives outcomes after CAR T-cell therapy for multiple myeloma: a registry analysis from the DRST. (PubMed, Blood) - "This study examines the real-world efficacy and safety in 343 triple-class exposed patients with relapsed and refractory multiple myeloma (RRMM) who received idecabtagene vicleucel (ide-cel, n=266) or ciltacabtagene autoleucel (cilta-cel, n=77) after more than three prior lines of therapy in Germany. Cilta-cel demonstrated a greater capacity for response conversion and durable remission. These findings underscore the need for individualized CAR T therapy selection to optimize patient outcomes."

Clinical • Journal • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

MM CAR-T to Upgrade Response BMTCTN1902 (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: Marcelo Pasquini, MD | Active, not recruiting ➔ Completed | Trial primary completion date: Jan 2025 ➔ Aug 2024

Trial completion • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology • CD34

A successful control of cardiac amyloidosis by idecabtagene vicleucel in a patient with relapsed and refractory multiple myeloma: a case report and literature review. (PubMed, Int J Hematol) - "He has maintained both hematological and cardiac remission for over 1 year since ide-cel therapy. This case highlights the effectiveness of ide-cel for disease control in heavily pretreated MM with cardiac amyloidosis."

Journal • Amyloidosis • Cardiac Amyloidosis • Cardiovascular • Critical care • Hematological Disorders • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

Keeping an eye on immune effector cell-associated neurotoxicity syndrome (ICANS): Outcomes and predictors of mortality. (ASCO 2025) - " Among 3,910 CAR-T cell therapy admissions in 2022, Axicabtagene Ciloleucel was the most frequently used (52%), followed by Idecabtagene Vicleucel (17%) and Brexucabtagene Autoleucel (14%). ICANS remains a significant complication of CAR-T cell therapy affecting 1 in 5 hospitalized patients. Identifying risk factors like nutritional status, history of stroke, and seizures is important in hospitalized patients. Management plan based on type of CAR-T cell therapy can improve overall outcomes."

Cardiovascular • CNS Disorders • Epilepsy • Hematological Malignancies • Infectious Disease • Ischemic stroke • Oncology • Pneumonia • Respiratory Diseases

Pharmacovigilance analysis of secondary primary malignancies and antibiotic interactions in CAR-T cell therapies. (PubMed, Ther Adv Drug Saf) - "Antibiotics were associated with a decreased risk of SPMs in patients treated with anti-CD19 CAR-T therapies, particularly brexucabtagene autoleucel. Conversely, a higher risk of SPMs was observed in association with antibiotics for anti-BCMA therapies, with idecabtagene vicleucel showing a notably elevated risk...Antibiotics were associated with both the risk and timing of SPMs in patients undergoing CAR-T cell therapy. This study highlights the need for further research to better understand the complex interactions between antibiotics and CAR-T therapies, as well as the potential implications for clinical management and patient care."

Adverse events • Journal • Hematological Disorders • Hematological Malignancies • Oncology

Real-world outcomes of CAR-T in the outpatient setting. (ASCO 2025) - "The most commonly used products were axicabtagene ciloleucel (43.0%), idecabtagene vicleucel (15%), and brexucabtagene autoleucel (11.2%). Any-grade Cytokine release syndrome (CRS) was reported in 66.4% of patients for which Tocilizumab was administered in 92.7%. Any-grade neurotoxicity was reported in 27.7% of which steroids with/without Anakinra was administered in 95.8%... Our experience revealed that treatment with CAR-T in the outpatient setting is safe and feasible with adequate institutional experience. Proper toxicity monitoring and management could help optimize healthcare utilization, and CAR-T accessibility."

Clinical • Real-world • Real-world evidence • B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

A Study of Whether Ide-cel (bb2121) Can Be Made From People With Multiple Myeloma Who Have Had a Hematopoietic Cell Transplant (clinicaltrials.gov) - P2 | N=32 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: May 2025 ➔ May 2026 | Trial primary completion date: May 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation • SDC1

Comparative assessment of colitis-related adverse events in multiple myeloma patients treated with teclistamab, ciltacabtagene, and idecabtagene: Incidence, outcomes, and risk assessment. (ASCO 2025) - "This analysis reveals notable differences in colitis-related AEs among patients treated with teclistamab, ciltacabtagene, and idecabtagene. Teclistamab showed the highest rates of severe colitis, including immune-mediated enterocolitis and Clostridium difficile infections. Ciltacabtagene had a broader spectrum of GI-related AEs and higher mortality rates, requiring careful monitoring."

Adverse events • Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Bowel Disease • Multiple Myeloma • Oncology • Ulcerative Colitis

Systematic review of BCMA-targeted therapies in relapsed/refractory (R/R) multiple myeloma (MM). (ASCO 2025) - "KarMMA-3 and CARTITUDE-4 use CAR-T cell therapies idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel)...DREAMM-3, DREAMM-7, and DREAMM-8 examine the ADC belantamab mafodotin (maf), as monotherapy or with dexamethasone (d) and bortezomib (V) or pomalidomide (P)... Innovative therapies such as CAR-T and ADCs outperform standard regimens, supporting the evolving landscape of R/R MM treatment. CAR-T cell therapies cilta-cel and ide-cell were approved for 2L+ and 3L+ MM, respectively, based on CARTITUDE-4 and KarMMa-3 trials. Meanwhile, the ADC belantamab maf conditional approval was withdrawn following DREAMM-3 failure to meet its primary endpoint, and it remains under evaluation."

Review • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

Comparative efficacy of idecabtagene vicleucel and ciltacabtagene autoleucel in relapsed/refractory multiple myeloma: Real-world analysis of overall survival and time to next treatment. (ASCO 2025) - "In this RW analysis, CC showed improved durability in delaying subsequent therapy compared to IC, as reflected by a significant TTNT benefit. However, this advantage did not translate into improved OS during the follow-up period. Differences in follow-up duration and RW data limitations, including potential missing data, may have influenced outcomes."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma • Oncology

Outpatient administration of idecabtagene vicleucel in relapsed refractory multiple myeloma without planned prophylaxis or remote monitoring. (ASCO 2025) - "Fludarabine plus cyclophosphamide was the lymphodepletion regimen used for all patients...Most CRS events occurred within 1 day of infusion (83%) and Tocilizumab was used to manage all CRS events. Grade 1 ICANS was reported in one patient for whom steroids and Anakinra was used for management... Our findings indicate that outpatient administration of Idecabtagene Vicleucel is feasible with adequate institutional experience and proper toxicity monitoring and management. The majority of patients were still living, so longer follow up time is required to explore the full outpatient experience for patients on this treatment and to understand all pertinent patient outcomes."

Clinical • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Oncology

Disease response at apheresis and association with long-term outcomes following CAR-T cells for relapsed/refractory multiple myeloma (RRMM). (ASCO 2025) - "Funded by No funding sources reported Background: The two approved BCMA-targeted CAR-T products, cilta-cel and ide-cel, have significant efficacy in RRMM, but are not considered curative. Our data suggest that disease control (≥SD) at time of T-cell collection is associated with more durable responses, supporting use of CAR-T cells as a consolidation strategy in RRMM. We cannot conclude these associations are causal. Further analyses of apheresed T cell characteristics are planned."

CAR T-Cell Therapy • Hematological Malignancies • Multiple Myeloma • Oncology