Isocel (ALEXIS-ISO-1)
/ Immunocell Therapeutics
- LARVOL DELTA
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September 01, 2026
Real-World Comparison of Axi-Cel and Liso-Cel in Richter Transformation
(SOHO 2026)
- "We compared the efficacy and safety of axicabtagene ciloleucel (axi-cel) and lisocabtagene maraleucel (lisocel) in patients with RT...Propensity score matching (1:1) was performed for age, sex, race, prior chemotherapy exposure, and prior treatment with BTK inhibitors and venetoclax... In this real-world RT cohort, axi-cel and liso-cel demonstrated comparable survival outcomes, hospice utilization, and toxicity profiles. These findings provide comparative evidence supporting the clinical utility of both products in this high-risk disease setting. CAR-T: chimeric antigen receptor T-cell, CD: cluster of differentiation, CI: confidence interval, CLL: chronic lymphocytic leukemia, CRS: cytokine release syndrome, DLBCL: diffuse large B-cell lymphoma, HR: hazard ratio, ICD-10: International Classification of Diseases, Tenth Revision, RT: Richter transformation."
Clinical • Real-world • Real-world evidence • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • Small Lymphocytic Lymphoma
September 01, 2026
Real-World Comparative Study of the Effectiveness, Safety, and Health Care Resource Utilization of Lisocabtagene Maraleucel and Bispecific Antibodies in Third-Line or Later Large B-Cell Lymphoma
(SOHO 2026)
- " Patients with LBCL newly treated with liso-cel or BsAbs (epcoritamab, glofitamab) in 3L+ (04/2022–05/2025) were identified from the US Flatiron Health Research Database, which collects longitudinal clinical electronic health records...There was no grade ≥3 CRS with lisocel (0% vs 3%) and similar grade ≥3 ICANS (5% vs 3%)... In this retrospective, real-world analysis, liso-cel demonstrated significantly better efficacy and similar HCRU and safety versus BsAbs as a 3L+ LBCL therapy."
Bispecific • Clinical • HEOR • Real-world • Real-world evidence • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20
September 01, 2026
Long-Term Outcomes and Toxicity Patterns of CD19 CAR-T Therapy Across Relapse and Refractory B-Cell Lymphomas: A Cross-Trial Synthesis
(SOHO 2026)
- "In R/R FL, axi-cel (ZUMA-5) showed ORR 94%, CR 80%, and mPFS of 40.2 months; tisa-cel (ELARA) achieved ORR 86%, CR 69%, and mPFS 30 months; lisocel (TRANSCEND-FL) reported ORR 97%, CR 94%, and mPFS 23.1 months. CD19 CAR-T therapy induces durable remission across R/R B-cell lymphomas, with differences in efficacy and toxicity by construct and histology. CD28-based therapies favor rapid disease control but higher toxicity. 4–1BB constructs offer improved tolerability with increased risk of prolonged cytopenias."
CAR T-Cell Therapy • IO biomarker • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
September 01, 2026
Comparative Real-World Efficacy and Safety of 4-1BB–Based (Liso-Cel/Tisa-Cel) vs CD28 Construct–Containing (Axi-Cel) CAR T-Cell Therapy for Relapsed/Refractory Large B-Cell Lymphomas: A Meta-Analysis
(SOHO 2026)
- "Based on real-world evidence, liso-cel and axi-cel demonstrate superior clinical efficacy compared with tisa-cel in the treatment of R/R LBCL. Notably, lisocel represents a favorable therapeutic middle ground, offering a toxicity profile significantly more manageable than axi-cel while maintaining comparable survival and response outcomes. Conversely, tisa-cel was associated with inferior response rates and survival despite its low neurotoxicity."
CAR T-Cell Therapy • Real-world • Real-world effectiveness • Real-world evidence • Retrospective data • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
September 01, 2026
Comparative Efficacy and Safety of Available CD19-Directed Chimeric Antigen Receptor T-Cell Therapies for Treatment of Relapsed/Refractory Large B-Cell Lymphomas: A Network Meta-Analysis
(SOHO 2026)
- " Four databases were searched for studies evaluating four major CAR-T products: axicabtagene ciloleucel (axi-cel), lisocabtagene maraleucel (liso-cel), tisagenlecleucel (tisa-cel), and zamtocabtagene autoleucel (zamto-cel)...P-score ranking identified axi-cel as the best overall therapy for OS (P score, 0.93) and PFS (P score, 0.83), whereas lisocel ranked highest for EFS (P score, 0.82)... Among currently available CAR-T therapies, axi-cel appears to demonstrate the strongest efficacy profile, with improved response rates and survival outcomes, followed by liso-cel and potentially zamto-cel. Tisa-cel, while ranking lower in efficacy outcomes, appears to be associated with a more favorable safety profile, particularly with regard to neurological toxicities. CAR-T: chimeric antigen receptor T-cell, CD: cluster of differentiation, CI: confidence interval, CRS: cytokine release syndrome, EFS: event-free survival, HR: hazard ratio, NE: neurological events, NHL: non-Hodgkin..."
CAR T-Cell Therapy • Retrospective data • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
September 01, 2026
Real-World Outcomes of Lisocabtagene Maraleucel in Patients With Relapsed and/or Refractory Mantle Cell Lymphoma
(SOHO 2026)
- "Liso-cel demonstrated high response rates in pretreated R/R MCL patients, consistent with pivotal trial results, with a manageable safety profile with low-grade CRS and ICANS but a relatively high rate of late infections. These findings support the real-world effectiveness and safety of lisocel in R/R MCL. BTK: Bruton tyrosine kinase, CAR-T: chimeric antigen receptor T-cell, CD: cluster of differentiation, CRR: complete remission rate, CRS: cytokine release syndrome, del17p: deletion 17p, ICANS: immune effector cell–associated neurotoxicity syndrome, Ki-67: antigen Kiel 67, ORR: overall response rate, OS: overall survival, PFS: progression-free survival, TP53: tumor protein p53, US: United States."
Clinical • IO biomarker • Real-world • Real-world evidence • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • TP53
September 01, 2026
Outcomes of Lisocabtagene Maraleucel in Patients With Relapsed or Refractory Mantle Cell Lymphoma: First Real-World Data From the Center for International Blood and Marrow Transplant Research
(SOHO 2026)
- P1 | "We present real-world outcomes for patients with R/R MCL who received lisocel. Liso-cel was associated with high response rates in a broad population of patients with R/R MCL, with early signs of durable benefit and safety profile consistent with TRANSCEND NHL 001. AE: adverse effect, CIBMTR: Center for International Blood and Marrow Transplant Research, CR: complete response, CRS: cytokine release syndrome, DoR: duration of response, HSCT: hematopoietic stem cell transplantation, ICANS: immune effector cell-associated neurotoxicity syndrome, liso-cel: lisocabtagene maraleucel, MCL: mantle cell lymphoma, NHL: non-Hodgkin lymphoma, NRM: nonrelapse mortality, ORR: objective response rate, OS: overall survival, PFS: progression-free survival, R/R: relapsed or refractory. Funding: Bristol Myers Squibb."
Clinical • Real-world • Real-world evidence • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Skin Cancer
May 12, 2026
COMPARATIVE REAL‑WORLD OVERALL SURVIVAL IN DIFFUSE LARGE B‑CELL LYMPHOMA: CAR T‑CELL THERAPIES VERSUS BISPECIFIC ANTIBODIES
(EHA 2026)
- "Two cohorts were analyzed: (1) DLBCL patients ≤60 years old treated solely with BsAbs (epcoritamab/glofitamab), and (2) DLBCL patients ≤60 years old treated solely with CAR T-therapies (tisacel/axicel/lisocel). While CAR T-cell therapies showed better survival over 2 years, the data's aggregate nature limits detailed clinical interpretation, including disease and treatment factors affecting outcomes. Still, the results support using CAR T-cell therapies over BsAbs for eligible younger patients with R/R DLBCL and emphasize the need for more research with patient-level data to improve comparative assessments."
Bispecific • CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • Asthma • Atherosclerosis • B Cell Lymphoma • Cardiovascular • Chronic Obstructive Pulmonary Disease • Coronary Artery Disease • Diffuse Large B Cell Lymphoma • Heart Failure • Hematological Malignancies • Immunology • Lymphoma • Non-Hodgkin’s Lymphoma • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • CD20
May 12, 2026
IMPACT OF PRIOR LINES OF THERAPY ON PROGRESSION RISK AND POST-FAILURE OVERALL SURVIVAL FOLLOWING AXICABTAGENE CILOLEUCEL OR LISOCABTAGENE MARALEUCEL CAR T-CELLS THERAPY.
(EHA 2026)
- "Over the last decade, Axicabtagene ciloleucel (Axicel) and Lisocabtagene maraleucel (Lisocel) were approved for patients who had failed two or more therapies, with 5- year OS of 38%- 42%. Summary/Conclusion Despite limitations inherent to our population and the high number of primary refractory pts treated in 2L, this study showed that the probability of PD within 6 months following CAR T-cells was 20% lower in 2L+ than in 4L+. Despite a significant increase in bispecific therapy after 2L CAR T-cells failure, 1-year OS2 remained poor, underscoring a critical unmet clinical need."
CAR T-Cell Therapy • Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma
February 07, 2026
EFFICACY AND SAFETY OF GRANULOCYTE COLONY STIMULATING FACTOR (GCSF) USE FOLLOWING CHIMERIC ANTIGEN RECEPTOR T CELL THERAPY (CAR-T): A SYSTEMATIC REVIEW
(EBMT 2026)
- "CAR-T types included axi-cel, tisa-cel, brexa-cel, and lisocel.All studies assessed the impact of GCSF on CRS, ICANs, and neutropenia duration, with 8 also reporting on neutropenia severity. Our findings demonstrated that GCSF use may potentially exacerbate the rates and severity of CRS rates associated with CAR-T cell therapy. Given above, the routine use GCSF to reduce infection risks post CAR T cell therapy should be avoided while awaiting randomized, prospective data confirming the efficacy of growth factors in preventing infections without exacerbating CRS."
CAR T-Cell Therapy • Review • Febrile Neutropenia • Hematological Malignancies • Infectious Disease • Neutropenia
March 14, 2026
EFFICACY AND SAFETY OF GRANULOCYTE COLONY STIMULATING FACTOR (GCSF) USE FOLLOWING CHIMERIC ANTIGEN RECEPTOR T CELL THERAPY (CAR-T): A SYSTEMATIC REVIEW
(EBMT 2026)
- "CAR-T types included axi-cel, tisa-cel, brexa-cel, and lisocel.All studies assessed the impact of GCSF on CRS, ICANs, and neutropenia duration, with 8 also reporting on neutropenia severity. Our findings demonstrated that GCSF use may potentially exacerbate the rates and severity of CRS rates associated with CAR-T cell therapy. Given above, the routine use GCSF to reduce infection risks post CAR T cell therapy should be avoided while awaiting randomized, prospective data confirming the efficacy of growth factors in preventing infections without exacerbating CRS."
CAR T-Cell Therapy • Review • Febrile Neutropenia • Hematological Malignancies • Infectious Disease • Neutropenia
January 08, 2026
Higher Fludarabine Exposure Correlates with Attenuated Systemic Inflammation and Improved Outcomes after CD19 CAR-T for Large B-cell Lymphoma
(TCT-ASTCT-CIBMTR 2026)
- "Results : This is a single-center study of 297 patients with LBCL treated with CD19 CAR-T (46% axicel, 35% lisocel, 20% tisacel). 2) Fludarabine exposure >14 mg*h/L was associated with significantly improved PFS after multivariable adjustment for age, CAR T product, LDH, and InflaMix signature. 3) In patients with high systemic inflammation (high InflaMix), higher fludarabine exposure during lymphodepletion reduced inflammation and improved PFS, supporting PK-guided dosing to optimize outcomes."
IO biomarker • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • IL10 • IL6
December 05, 2025
Comparative outcomes of CAR-T cell therapy with and without autologous stem cell transplant consolidation in diffuse large B-cell lymphoma: A real-world propensity-matched analysis
(ASH 2025)
- " Using TriNetX, adults (≥18 years) with DLBCL treated with tisacel, lisocel or axicel were identified. ASCT after CAR-T in DLBCL did not improve OS and was associated with increased MDS incidence and higher ICU and hospitalization hazards. Further clinical trials should be designed and studied."
CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • Acute Myelogenous Leukemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Transplantation
December 05, 2025
Health care utility and real-world comparison of CAR T-cell therapy versus autologous stem cell transplantation in Relapsed/Refractory diffuse large B-cell lymphoma: A propensity score-matched outcomes analysis
(ASH 2025)
- " Using the TriNetX Global Collaborative Network, we identified adults (≥18 years) with DLBCL who received either CAR T-cell therapy (axicel or lisocel) or ASCT between February 2021 and August 2024. In this real-world matched analysis, ASCT was associated with improved overall survival compared to CAR T-cell therapy in patients with R/R DLBCL, which could reflect the fact that patients eligible for ASCT were those who achieved remission status and transplant eligible. For healthcare utility perspective, CAR T therapy was linked to lower hospitalization risk, yet associated with increased ICU utilization and infectious complications compared to those of ASCT."
CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Transplantation
November 04, 2025
Multi-center real world analysis of treatment outcomes of non-COVALENT btki, pirtobrutinib, in patients with COVALENT btki relapsed/refracdtory Mantle Cell Lymphoma
(ASH 2025)
- "Brexucel,lisocel, and the non-covalent BTKi pirto have been approved in this population...Ninety-one pts (86%) received chemo-immunotherapy (CIT), 16 (15%) autologous stem celltransplant, 19 (18%) venetoclax (ven), 29 (27%) chimeric antigen receptor T-cell, 4 (4%) allogeneic stemcell transplant. For cBTKi, 39 (35%) pts received ibrutinib, 56 (50%) pts acalabrutinib, 33 (30%) ptszanubrutinib, and 17 (15%) pts received more than one cBTKi... This is the first RW report on pirto in MCL pts. In this high-risk population, ORR to pirto wascomparable to the BRUIN trial, while PFS was significantly worse, especially in pts w/ no response to cBTKiand w/ a high Ki67. However, prolonged remissions were seen in a subset of pts, suggesting that a bettercharacterization of this population w/ durable benefit from pirto is needed."
Clinical • IO biomarker • Real-world • Real-world evidence • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • TP53
November 04, 2025
Checkpoint inhibitors exposure does not affect survival and safety in PMBCL patients receiving CAR T-cells therapy: An analysis of the italian CART-SIE study
(ASH 2025)
- "Among the 1309 patients (pts) enrolled in the study, 93 with R/R PMBCL whoreceived axicel (n=90) or lisocel (n=3) were eligible for this analysis...The type of CPI used,Nivolumab or Pembrolizumab, had no impact on either OS or PFS...Findings ofthis study suggest that the use of CPI is safe and may be beneficial as part of salvage therapy to improvedisease control before infusion or to rescue patients following CAR T-cell failure. Due to the limitednumber of patients experiencing CAR T-cell failure, the optimal salvage strategy in this setting remainsundetermined."
CAR T-Cell Therapy • Checkpoint inhibition • Clinical • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma
November 04, 2025
Duration of lymphopenia after CAR-T cell therapy is associated with increased risk of non-melanoma skin cancers and decreased survival
(ASH 2025)
- "Bendamustine was lymphodepletion (LD) for 223 pts (78.5%) (NMSC, n=15[71.4%]; no NMSC, n=208 [79.1%]; ALC-R, n=121 [78.6%]; ALC-NR, n=102 [78.5%]). Of 369 pts screened, 284 were eligible for analysis (22 excluded due to death before CAR-T, 63due to prior NMSC). Of 284 pts, 21 (7.4%) developed NMSC post CAR-T. For 21 pts with NMSC post CAR-T,median age was 65 years (yrs; IQR 61-71); 16 pts (76.2%) were male; 19 (90%) had large B-cell (LBCL), 1(5%) follicular (FL), 1 (5%) mantle cell (MCL) lymphoma; 12 pts (57.1%) received tisacel, 5 (23.8%) axicel, 3(14.3%) lisocel, 1 (4.8%) brexucel."
CAR T-Cell Therapy • IO biomarker • Lymphopenia • B Cell Lymphoma • Genetic Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Non-melanoma Skin Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • CD4
November 04, 2025
Image-based classification of lymphocyte subsets from routine blood smears reveals distinct immune dynamics after CAR-T infusion
(ASH 2025)
- "Liso-cel and ide-celdemonstrated sustained near-peak absolute lymphocyte count (ALC) levels through day 30...For example, when comparing Axicel to Lisocel, Lisocel hassignificantly higher ABLs (p<0.01) and lower DCLs (p<0.05)... Peripheral blood smears, a widely available and cost-effective modality, reveal distinct lymphocytemorphologies emerging after CAR-T infusion that can be reproducibly classified using deep learning.These morphologic fingerprints correlate with clinical outcomes and support the further development ofPBS-based immune profiling as a scalable approach for real-time monitoring of CAR-T patients."
Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma
November 06, 2025
Impact of hematopoiesis on collection efficiency for autologous CAR T-cell therapy
(DGHO 2025)
- "Thereof, commercial CD19-specific and BCMA-specific CAR T-cell products, respectively, (Axicel, Brexucel, Lisocel, Tisacel, Idecel), or CD19-directed CAR T-cells as part of the HD-CAR-1 trial were produced. Statistical analyses included Spearman's correlation, Student's t-test, Welch's t-test, and Mann-Whitney-U test, depending on data distribution. In 181 patients, a sufficient CD3+ T-cell yield was achieved for CAR T-cell manufacturing, while four patients required a second leukapheresis due to not reaching the target yield of ≥10×10⁸ in three patients (Tisacel) and a markedly low CD3+ T-cell yield in one patient possibly due to prior treatment with polatuzumab, bendamustine... For most patients, a sufficient amount of CD3+ T-cells can be collected by a single leukapheresis procedure. However, these findings highlight that leukapheresis for CAR T-cell manufacturing is a critical step and timing is important to reach optimal CAR T-cell therapy outcomes."
CAR T-Cell Therapy • Acute Lymphocytic Leukemia • B Cell Lymphoma • Hematological Malignancies • Leukemia • Leukopenia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • CD8
November 03, 2023
Impact of Response to Systemic Bridging Therapy on Clinical Outcomes and Cytokine Profiles in Patients Receiving CD19- CAR T-Cell Therapy for B-Cell Lymphoma
(ASH 2023)
- "BT was classified as Polatuzumab (pola) based, intensive chemotherapy, lenalidomide/ Bruton tyrosine kinases inhibitors (len/BTKi), or others...Among all pts, 86 (47%) received Axicel, 49 (27%) Tisacel, 36 (20%) Lisocel and, 11 (6%) Brexucel... Our findings suggest that achieving a response to BT is associated with reduced tumor burden and inflammatory markers pre-LD, reflecting inherent disease biology and treatment-refractoriness. Further studies are required to evaluate which BT strategies may optimize the inflammatory cytokine environment for improved outcomes after CD19 CAR T cell therapy."
CAR T-Cell Therapy • Clinical • Clinical data • IO biomarker • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IL6
November 06, 2024
Real World Comparison of Axicabtagene Ciloleucel and Lisocabtagene Maraleucel in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
(ASH 2024)
- "Background : Chimeric antigen receptor T-cell (CAR-T) therapies targeting CD19, such as Axicabatagene ciloleucel (axicel) and Lisocabtagene maraleucel (lisocel), have shown efficacy with a tolerable safety profile in the treatment of relapsed or refractory diffuse large B-cell lymphoma (RR DLBLC) in clinical trials. Although comparisons for OS cannot be made due to published trial's data maturity, this study provides real-world evidence for pts with RR DLBCL who underwent treatment with either axicel or lisocel. Further maturation of data from clinical trials is needed to better guide treatment for these groups, but comparison data from our analysis looks promising and doesn't show any significant difference between the two products."
Clinical • Real-world • Real-world evidence • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
November 11, 2025
Length of Stay (LOS) and Associated Healthcare Resource Use (HCRU) for a First Infusion of Axi-cel or Lisocel in Second Line for Large B-cell Lymphoma in France: Differences Observed From Comprehensive Hospital Databases
(ISPOR-EU 2025)
- "The majority were monoclonal antibodies, with 48.7% of patients treated with axi-cel (n=167) and 13.5% of patients treated with liso-cel (n=5) receiving tocilizumab or siltuximab. Despite the limited number of patients, a shorter LOS is observed in patients treated with liso-cel compared to those treated with axi-cel, with fewer ICU and extra-DRG drugs, a potential proxy for safety."
Clinical • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma
September 15, 2025
A Post-marketing Analysis of Autoimmune Toxicities Following Chimeric Antigen Receptor T-cell Therapy Using the FDA Adverse Event Reporting System
(ACR Convergence 2025)
- "All individual case safety reports listing any of the CAR-T therapies—tisagenlecleucel (tisacel), axicabtagene ciloleucel (axicel), lisocabtagene maraleucel (lisocel), brexucabtagene autoleucel (brexucel), idecabtagene vicleucel (idecel), and ciltacabtagene autoleucel (ciltacel)—as the suspected drug were included. This post-marketing pharmacovigilance analysis highlights product- and disease-specific patterns of autoimmune AEs following CAR-T therapy. While limited by FAERS reporting bias, these findings support the need for monitoring strategies and emphasize the importance of prospective studies to validate these associations. Integrating pharmacogenomic and immunologic correlates may further elucidate underlying mechanisms."
Adverse events • CAR T-Cell Therapy • IO biomarker • P4 data • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Complement-mediated Rare Disorders • Follicular Lymphoma • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Indolent Lymphoma • Inflammatory Arthritis • Leukemia • Lupus • Lymphoma • Musculoskeletal Diseases • Myositis • Non-Hodgkin’s Lymphoma • Ocular Inflammation • Ophthalmology • Optic Neuritis • Rheumatology • Sarcoidosis • Vasculitis • ROR1
November 06, 2025
"AUC fludarabine and product choice are main predictors of CRS/ICANS after CAR T cell therapy: generation of an improved model"
(DGHO 2025)
- "Additionally, previous studies only comprised patients treated with tisacel, axi-cel, and a few experimental products. The effects of mEASIX and AUC fludarabine on CRS/ICANS in liso-cel treated or multiple myeloma (MM) patients are unknown... Elevated AUC fludarabine was significantly associated with CRS/ICANS>=°II. In contrast, lisocel and MM were associated with decreased risk. The previously reported association of mEASIX with CRS/ICANS was less pronounced in our models."
CAR T-Cell Therapy • Chronic Kidney Disease • Hematological Malignancies • Multiple Myeloma
August 30, 2025
A Post-Marketing Analysis of Gastrointestinal Adverse Events Following Chimeric Antigen Receptor T-Cell Therapy Using the FDA Adverse Event Reporting System
(ACG 2025)
- "Individual case safety reports listing any CAR-T therapies—Tisagenlecleucel (tisacel), Axicabtagene Ciloleucel (axicel), Lisocabtagene Maraleucel (lisocel), Brexucabtagene Autoleucel (brexucel), Idecabtagene Vicleucel (idecel), and Ciltacabtagene Autoleucel (ciltacel)—as the suspected drug for GI AEs were included. There were 1395 GI AEs with CAR-T reported in FAERS (Table 1). Compared to other CAR-T, Ciltacel was associated with immune effector-cell mediated enterocolitis (IEC-EC) and non-immune colitis; Lisocel with GI ulceration, necrosis, and cholestasis; Idecel with functional/motility disorders; and Axicel and Tisacel with GI bleed. Tisacel was also associated with abnormal liver function tests, pancreatitis, and functional/motility disorders.Distinct patterns were observed based on primary cancer."
Adverse events • CAR T-Cell Therapy • P4 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Cholestasis • Diffuse Large B Cell Lymphoma • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Hematological Malignancies • Hepatology • Immunology • Large B Cell Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Pancreatitis • Primary Mediastinal Large B-Cell Lymphoma
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