Tecartus (brexucabtagene autoleucel) / Gilead, Fosun Kite - LARVOL DELTA

Therapy Sequencing in Relapsed/Refractory MCL (ICML 2025) - P1, P1/2, P2, P3 | "Although a direct comparison between them has only been performed for ibrutinib and temsirolimus [23], covalent BTK inhibitor (cBTKi) single agent therapy has been consolidated as the standard of care after first-line CIT. Moreover, to address cBTKi failure, two anti-CD19 CAR-T cell therapy products, brexucabtagene autoleucel [20, 21] and lisocabtagene maraleucel [22], and the first noncovalent BTKi, pirtobrutinib [19], have recently been approved...Liso-cel only FDA approved; CIT, chemoimmunotherapy options include BR, R-BAC, R-CHOP, R-DHAP or R-DHAOx, R-GEMOx, paliative options (avoid bendamustine pre-CART apheresis); pirtobrutinib, available after cBTKi failure in second-line (EMA) but third-line (FDA); RM, rituximab maintenance...Orelabrutinib [18] is licensed only in China...Of note, both acalabrutinib and zanubrutinib induce lower rates of atrial fibrillation, hypertension, and bleeding compared to ibrutinib in randomized studies..."

IO biomarker • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Oncology • PLCG2 • TP53

Low Occurrence of Ocular Adverse Events after CAR-T Cell Therapy. (PubMed, Ocul Oncol Pathol) - "Billing codes were used to identify patients receiving autologous CAR-T therapy approved by the US Food and Drug Administration (FDA) for the treatment of a hematological malignancy: tisagenlecleucel, brexucabtagene autoleucel, lisocabtagene maraleucel, ciltacabtagene autoleucel, idecabtagene vicleucel, or axicabtagene ciloleucel. In the period of 6 months following CAR-T therapy infusion, o-AEs were rare in patients receiving CAR-T cell therapy, indicating that patients without existing eye conditions do not need routine prescreening or directed follow-up after treatment, unless symptomatic. Ongoing monitoring and reporting of ocular adverse events will be important given the durable effects of CAR-T therapy in the treatment of hematologic cancers as well as increasing indications for CAR-T therapy in malignant and nonmalignant disease."

Adverse events • Journal • Conjunctivitis • Dry Eye Disease • Hematological Disorders • Hematological Malignancies • Herpes Zoster • Keratitis • Leukemia • Lymphoma • Ocular Infections • Ocular Inflammation • Oncology • Ophthalmology • Optic Neuritis • Uveitis

CAR T cell therapy in acute lymphoblastic leukemia (PubMed, Inn Med (Heidelb)) - "Modern immunotherapy in the form of T‑cell-based CD19-targeted approaches, such as the approved bispecific T‑cell engager (BiTE antibody) blinatumomab and chimeric antigen receptor T cells (CAR T cells) with the approved products tisagenlecleucel and brexucabtagene autoleucel has revolutionized the treatment of B‑precursor acute lymphoblastic leukemia (ALL). Furthermore, resistance mechanisms are discussed and an outlook on further development is given. The T‑precursor ALL remains a challenge due to its immunological complexity but new developments in CAR-T cell treatment approaches targeting CD5 and CD7 show that progress is also being made in this area."

Journal • Review • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • CD5 • CD7

Post-marketing Safety Assessment of CAR T-cell Therapies: Analysis of Individual Case Safety Reports in the VigiBase. (PubMed, Ther Innov Regul Sci) - "Our study provides an overall exploration of the post-marketing safety profiles of currently approved CAR-T cell therapies. The significant proportion of fatalities occurred in accordance with approved indications, emphasizes the need for ongoing investigation into ADRs with fatal outcomes, particularly in the pediatric population."

Journal • P4 data • Hematological Disorders • Hematological Malignancies • Oncology • Pediatrics

Real-world outcomes of brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma: a CIBMTR analysis. (PubMed, Blood Adv) - "Here, we report real-world effectiveness and safety outcomes of brexu-cel in a prospective study of patients with r/r MCL, including subgroups based on prior treatment with Bruton's tyrosine kinase inhibitor, bendamustine, or autologous hematopoietic cell transplant (auto-HCT) and number of prior therapy lines, using Center for International Blood and Marrow Transplant Research registry data. In patients with 1-2 prior therapy lines, relapse or progression was less frequent compared with those with 3 or more prior lines (HR 0.64; 95% CI, 0.42-1.00). Collectively, our results suggest that real-world outcomes with brexu-cel were consistent with ZUMA-2, regardless of prior therapy type or number of prior therapy lines."

Journal • Real-world evidence • Hematological Disorders • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • Thrombocytopenia • Transplantation

(Cohort 3) ZUMA-2: Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3) (clinicaltrials.gov) - P2 | N=95 | Completed | Sponsor: Kite, A Gilead Company | Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

JKART-1: Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=25 | Active, not recruiting | Sponsor: Kite, A Gilead Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Oncology

Advancing Mantle Cell Lymphoma Risk Assessment: Navigating a Moving Target (ICML 2025) - "In addition to TP53 mutations, deletions of CDKN2A (p16) and TP53 were shown to have a poor prognostic value for both overall survival (OS) and time to failure (TTF) in the EMCL Younger cohort, independent of high-dose cytarabine induction [24]...Similarly, in the ALTAMIRA trial [33], patients received MRD-guided treatment with 6 cycles of acalabrutinib plus rituximab followed by maintenance for a total of 3 years...The triplet combination of zanubrutinib + obinutuzumab + venetoclax in the BOVen study with minimal residual disease (MRD)-guided discontinuation after 24 cycles of therapy showed a 2-year PFS of 72%, improving the results of historical cohorts. In the VIPOR trial [35], a fixed-duration, multi-agent targeted regimen (ViPOR) of 6 cycles of venetoclax, ibrutinib, obinutuzumab and lenalidomide without maintenance or consolidation was tested in 20 newly diagnosed and 16 relapsed MCL pts...Finally, results from a limited subset of the BRUIN study showed that..."

IO biomarker • Tumor mutational burden • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Oncology • CCND1 • CDKN2A • CDKN2B • IGH • KMT2D • MYC • SOX11 • TP53

Assessing the risk of cytokine release syndrome associated with the use of antineoplastic agents: A real-world pharmacovigilance study based on the FDA Adverse Event Reporting System database (FAERS). (ASCO 2025) - " Among the top 10 drugs associated with CRS, CAR-T therapies exhibited the strongest disproportionality signals, with Axicabtagene Ciloleucel (ROR: 1946.596, PRR: 1104.019), Tisagenlecleucel (ROR: 1541.613, PRR: 908.159), and Brexucabtagene Autoleucel (ROR: 1385.781, PRR: 815.937) ranking highest...Blinatumomab (ROR: 216.203, PRR: 195.902), a BiTE therapy, ranked fourth, reflecting a moderate but significant CRS signal. Fludarabine (ROR: 128.879, PRR: 121.137), an immunosuppressive agent used in lymphodepleting regimens before CAR-T therapy, also exhibited a notable CRS association, likely due to its role in enhancing immune cell expansion. Traditional chemotherapy agents demonstrated lower CRS signals, with Cyclophosphamide (ROR: 26.215, PRR: 25.886) and monoclonal antibody Rituximab (ROR: 6.973, PRR: 6.952) showing relatively modest disproportionality. Corticosteroids, which are commonly used to mitigate CRS symptoms, had the lowest disproportionality signals, with..."

Adverse events • Clinical • Cytokine release syndrome • Real-world • Real-world evidence • Inflammation • Oncology

First Line Therapy in Mantle Cell Lymphoma—The Role of BTKi in the Initial Treatment of Transplant-Eligible and -Ineligible Patients (ICML 2025) - P2, P3 | "1 = off-label use; ASCT = autologous stem cell transplantation; CHOP = cyclophosphamid, doxorubicin, vincristine, prednisone; CR = complete remission; DHAP = dexamethasone, high-dose cytarabine, cisplatin; I = ibrutinib; PR = partial remission; R = rituximab...Another promising approach for this high-risk group of patients was evaluated in a Phase 2 study of zanubrutinib, obinutuzumab, and venetoclax (BOVen) in untreated patients with MCL with a TP53 mutation [23]...This question is being addressed in the currently recruiting CARMAN trial, a randomized, controlled, international, multicenter, open-label phase II trial evaluating the efficacy and safety of brexucabtagene autoleucel following an abbreviated induction (3 cycles of ibrutinib + rituximab (IR) and 2 cycles of Ibrutinib + R-CHOP in patients not achieving at least a PR to IR), and 6 months ibrutinib maintenance starting 3 months post CAR-T-treatment (Arm A) as compared to standard of care..."

Clinical • IO biomarker • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • IGH • SOX11 • SOX2 • TP53

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

FIVE-YEAR SURVIVAL OUTCOMES OF PATIENTS (PTS) WITH RELAPSED OR REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (R/R B-ALL) TREATED WITH BREXUCABTAGENE AUTOLEUCEL (BREXU-CEL) IN ZUMA-3 (EHA 2025) - "The median follow-up time for pts ≥26 y (n=63) was 65.6 mo (range, 56.7-94.3); median OS remained unchanged since the 4-y analysis at 26.0 mo (95% CI, 15.9-NE) with a 5-y OS rate of 42% (95% CI, 28.6-53.9).The 5-y OS rates (95% CI) for pts with (n=38) and without (n=40) prior blinatumomab were 25% (12.1-40.4) and 54% (36.3-68.5); for pts with (n=17) and without (n=61) prior inotuzumab were 21% (5.2-43.9) and 45% (31.1-57.4); and for pts with (n=29) and without (n=49) prior allogeneic stem cell transplantation (alloSCT) were 36% (17.1-55.3) and 42% (26.9-55.5), respectively. Pts in ZUMA-3 continued to experience a survival benefit with a 40% 5-y OS rate. Responders had the greatest benefit with a median OS of >5 y (CR/CRi) and not reached in those with CR. Pts benefitted regardless of age, prior therapy, or subsequent alloSCT status, though small subgroups and unbalanced pt characteristics limit interpretation of post hoc subgroup analyses."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Cervical Cancer • Hematological Malignancies • Leukemia • Oncology • Respiratory Diseases • Solid Tumor

REAL-WORLD OUTCOMES OF ADULT B-ALL PATIENTS WHO EXPERIENCE RELAPSED OR REFRACTORY DISEASE FOLLOWING BREXUCABTAGENE AUTOLEUCEL, A STUDY BY THE ROCCA CONSORTIUM (EHA 2025) - "However, CR2 for specific therapies included subsequent CAR-T (100%), TKI monotherapy (64%), inotuzumab-containing regimen (53%), salvage chemotherapy (32%), blinatumomab-containing regimens (33%), or BCL2-inhibitor-containing regimens (22%). Outcomes of refractory B-ALL following commercial brexu-cel are poor with a median OS of 3 months underscoring a need for novel salvage therapies following bexu-cel failure. In contrast, patients who relapsed >6 months have an encouraging 1-year OS of 67%. Salvage treatment decisions should be personalized considering patient and disease specific factors."

Clinical • IO biomarker • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology

KTE-X19 IN RELAPSED OR REFRACTORY ADULT B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA IN THE CHINESE POPULATION: A PHASE II MULTICENTER STUDY (EHA 2025) - P2 | "Patients had a median of 2 (range 1-5) prior lines of therapy; 1 (3.6%) previously received blinatumomab, 4 (14.3%) previously received inotuzumab ozogamicin, and 7 (25%) previously received allo-SCT.Median follow-up was 8.1 mo (90% CI 5.9, 9.1), The CR/CRi rate was 78.6% (90% CI 62.0%, 90.2%). KTE-X19 demonstrated a high rate of CR or CRi in adult patients with R/R B-ALL and exhibited a manageable safety profile."

Clinical • P2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • CNS Disorders • Hematological Malignancies • Leukemia • Oncology

"Real World" Incidence and Characteristics of Immune Effector Cell–Associated Hemophagocytic Lymphohisticytosis: A GoCart Coalition Study on Behalf of the European Bone Marrow Trasplantation (EBMT) Autoimmune Disease Working Party (ADWP), Cellular Therapy Working Party (CTIWP) and transplant Complication Working Party(TCWP). (EULAR 2025) - "Secondary HLH occurred in 12 patients treated with tisagenlecleucel (42.9%), 10 with axicabtagene ciloleucel (35.7%), 4 with brexucabtagene autoleucel (14.3%), and 2 treated with other products (7.2%). Overall, this registry study reported an incidence of 3.6% of secondary HLH at 90 days after CAR-T cell treatment. Patients experienced heterogeneous clinical manifestations, mainly represented by fever and liver involvement. Anakinra and steroids represented the employed treatments and the overall survival was 80.9% at 90 days."

Clinical • IO biomarker • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Bone Marrow Transplantation • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

CAR-T CELLS SPECIFIC TOXICITIES AS MAJOR DETERMINANTS OF NON-RELAPSE MORTALITY: AN ANALYSIS FROM THE ITALIAN CART-SIE STUDY (EHA 2025) - "CAR-T product was Axicabtagene ciloleucel, Brexucabtagene autoleucel or Tisagenlecleucel in 55%, 21% and 24% pts, respectively; median age was 65 yrs (IQR 56-68); 2/47 had received CAR-T at 1st relapse. In our cohort, older age, CRS, ICANS and infections were major determinants of NRM. The stringent Italian Drug Agency eligibility criteria have excluded baseline patients' characteristics that might otherwise affect NRM, highlighting the predominant impact of CAR-T toxicities. While acute complications are usually well-managed, early intervention to prevent and mitigate CRS and ICANS could be furtherly refined to reduce NRM."

CAR T-Cell Therapy • B Cell Lymphoma • Cardiovascular • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

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

BRIDGING RADIOTHERAPY DOES NOT INCREASE RISK OF CAR T-CELL ASSOCIATED TOXICITY (ICML 2025) - "Patients received axicabtagene (38%), lisocabtagene (33%), tisagenlecleucel (15%), brexucabtagene (3%), or an investigational agent (11%). BRT does not appear to increase CRS or ICANS after CAR-T compared to historic controls. Extent of disease (evidenced by high residual LDH) prior to CAR-T may be a more important driver of toxicity, emphasizing the benefit of cytoreduction. Patients treated to higher BEDs saw lower toxicity suggesting that effective cytoreduction outweighs any theoretical risk of radiation-associated inflammation."

CAR T-Cell Therapy • B Cell Lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma

Management strategies for CAR-T cell therapy-related toxicities: results from a survey in Greece. (PubMed, Front Med (Lausanne)) - "Data from 173 adult patients receiving CAR-T cell products-axi-cel, tisa-cel, and brexu-cel-were analyzed...Centers utilized prophylactic measures, including levetiracetam and low-dose dexamethasone, significantly reducing severe toxicities. Tocilizumab was administered for CRS management, supplemented by anakinra or siltuximab in select cases...The variability in toxicity incidence reflects differences in patient populations, CAR-T constructs, and clinical practices. Further research is essential to optimize individualized management strategies and advance the safety of CAR-T therapies in clinical settings."

Journal • Hematological Disorders • Hematological Malignancies • Inflammation • Oncology • Transplantation

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

CART CELL THERAPY IN THE MANAGEMENT OF SECONDARY CENTRAL NERVOUS SYSTEM LYMPHOMA (ICML 2025) - "9 received radiation +/− Bruton Tyrosine Kinase inhibitor (BTKi) or polatuzumab vedotin (PV). Other bridging included BTKi (7), PV (1), lenalidomide (1) or venetoclax (1)...14 received tisagenlecleucel, 3 received lisocabtagene maraleucel, 2 received axicabtagene ciloleucel and 1 received brexucabtagene autoleucel. 17 received bendamustine lymphodepletion...CART is a feasible treatment for SCNSL. While there is a subset of pts who achieve long-term response, the majority will relapse in the CNS which signifies a need for novel CNS-directed therapies."

CAR T-Cell Therapy • B Cell Lymphoma • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • Secondary Central Nervous System Lymphoma

CD19-DIRECTED CHIMERIC ANTIGEN RECEPTOR-CELL THERAPY FOR B-CELL LYMPHOMAS WITH PRIMARY OR SECONDARY CNS INVOLVEMENT. REAL-WORLD DATA FROM A MULTICENTER ANALYSIS (ICML 2025) - "Patients: 19 consecutive pts with r/r PCNSL (n = 6) or SCNSL (n = 13) with a median age of 56 years were treated with tisagenlecleucel (tisa-cel), n = 7, axicabtagen-ciloleucel (axi-cel), n = 10, brexucabtagene autoleucel (n = 1) or lisocabtagene maraleucel (n = 1) between 2019 and 2024 in 3 centers...Lymphodepletion (LD) consisted of fludarabine and cyclophosphamide from day (d) -5 -to -3...Progression-free survival was not influenced by: primary or secondary CNS involvement, meningeosis lymphomatosa (Figure 1A–C), type of product when restricting the analysis to tisa-cel and axi-cel, prior methotrexate-containing therapy, or prior ASCT... CD19 directed CAR T-cells are safe and feasible in pts with PCNSL or SCNSL. Response rates were high and more than 50% of pts were still in CR 400d after CART."

Clinical • Real-world • Real-world evidence • B Cell Lymphoma • CNS Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma • Secondary Central Nervous System Lymphoma • CD4 • CD8

Comparative analysis of adverse event profiles for CAR-T cell therapies and bispecific antibodies in lymphoma. (ASCO 2025) - " A retrospective analysis was conducted using the FAERS database to assess AE reports associated with CAR-T therapies (Breyanzi, Kymriah, Yescarta, and Tecartus) and BsAbs (Epcoritamab, Glofitamab, Odronextamab, Mosunetuzumab, and Plamotamab). This analysis highlights key differences in the safety profiles of CAR-T and BsAb therapies for lymphoma. CAR-T therapies were associated with a higher incidence of neurological and psychiatric AEs, while BsAbs demonstrated a greater risk of infections. These findings may offer valuable guidance for clinicians in therapy selection and underscore the importance of vigilant monitoring, particularly for neurological toxicities in CAR-T treatments and infection-related risks with BsAbs."

Adverse events • CAR T-Cell Therapy • CNS Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Mental Retardation • Musculoskeletal Diseases • Oncology • Psychiatry

A novel application of deep learning (DL)-based MRI with liquid biomarkers for immune effector cell-associated neurotoxicity syndrome (ICANS) after chimeric antigen receptor (CAR) T-cell therapy. (ASCO 2025) - "Most (106) received axicabtagene ciloleucel (34 tisagenlecleucel, 23 brexucabtagene autoleucel) and most had CRS (133, 82%)... Here, we demonstrate a novel application of DL-based MRI quantification of ICANS post-CAR T-cell therapy. This metric, along with clinical features, emerged as potential quantitative biomarkers of ICANS. These findings warrant further investigation and have informed a prospective study, including standardized brain MRI pre- and post-infusion, to develop a comprehensive phenotype of neurotoxicity following CAR T-cell therapy."

Biomarker • Acute Lymphocytic Leukemia • CNS Disorders • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CRP

CAR-T CELL DYNAMICS AND MYELOID-CELL ALTERED PROFILE ARE ASSOCIATED WITH CLINICAL OUTCOME IN ANTI-CD19 CAR-T CELL THERAPY FOR RELAPSED/REFRACTORY B-CELL MALIGNANCIES: A REAL-LIFE COHORT STUDY (EHA 2025) - "Twenty patients received axicabtagene ciloleucel (axi-cel), 9 brexucabtagene autoleucel (brexu-cel) and 18 tisagenlecleucel (tisa-cel). These results indicate the presence of immunological biomarkers within IP. Moreover, the amount and clonality of circulating CAR-T, and myeloid cell phenotype can predict clinical outcomes, including the susceptibility to develop severe toxicities."

CAR T-Cell Therapy • Clinical • Clinical data • IO biomarker • Acute Lymphocytic Leukemia • B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD163 • CD86