Breyanzi (lisocabtagene maraleucel)
/ BMS
- LARVOL DELTA
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November 04, 2025
CAR T-cell therapy in secondary CNS lymphomas: A real-world study from the descar-t registry
(ASH 2025)
- P | "At the timeof CAR T-cell infusion, 109/195 (56%) patients were in complete (CR) or partial response (PR), and 84 (43%)had stable (SD) or progressive disease (PD) (missing data: 1%).One hundred thirty-eight (71%) patients received axi-cel, 26 (13%) tisa-cel, and 31 (16%) liso-cel. Efficacy and toxicity data, particularlywith respect to neurotoxicity, were consistent with those observed in systemic DLBCL. Further studies areneeded to support these results over the long term and to determine the optimal place of CAR T-cellswithin the therapeutic options of CNS lymphomas."
CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • B Cell Lymphoma • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Primary Central Nervous System Lymphoma • Secondary Central Nervous System Lymphoma
August 31, 2024
Accessing BTK Inhibitors and Other Novel Therapies for Mantle Cell Lymphoma: Are We All Invited to the Party?
(SOHO 2024)
- "In the phase 3 RAY trial,2 ibrutinib led to better responses and significant improvements in progression-free survival (PFS) and tolerability versus temsirolimus in patients with R/R MCL...In the SHINE trial,3 the combination of ibrutinib with bendamustine and rituximab for 6 cycles, followed by rituximab maintenance and ibrutinib until progression, led to an unprecedented PFS of 80.6 months in patients not eligible for ASCT...Second-generation BTK inhibitors have also been approved for R/R MCL, including acalabrutinib and zanubrutinib with a more favorable safety profile. In first line therapy, the results of bendamustine, rituximab, and acalabrutinib are expected to be presented soon...Pirtobrutinib, a third-generation non-covalent BTK inhibitor has shown promising activity in MCL after exposure to covalent BTK inhibitors. Moreover, the BCL-2 inhibitors, venetoclax and sonrotoclax, have also shown activity in the post-BTK inhibitor scenario, and sonrotoclax is..."
Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
September 01, 2026
Comparative Efficacy and Safety of Approved Therapies in ≥3L Relapsed/Refractory Large B-Cell Lymphoma: A Bayesian Network Meta-Analysis
(SOHO 2026)
- "Background: Multiple novel agents are approved for ≥3L relapsed/refractory large B-cell lymphoma, including chimeric antigen receptor T-cell (CAR-T) products (axicabtagene ciloleucel [axi-cel], lisocabtagene maraleucel [liso-cel], tisagenlecleucel [tisacel]), bispecific antibodies (epcoritamab, glofitamab, mosunetuzumab), antibody-drug conjugates (polatuzumab vedotin + bendamustine, rituximab [pola-BR], loncastuximab tesirine), and others (tafasitamab + lenalidomide, selinexor). CAR-T therapies ranked highest for CR rate but with greater toxicity and selection bias. Among bispecific antibodies, epcoritamab ranked among the most favorable for combined efficacy and safety (SUCRA, 58.3% vs 56.1% for glofitamab and 47.8% for mosunetuzumab). Given the near-disconnected, star-topology network and predominantly single-arm data, results carry very low certainty per CINeMA and should be interpreted cautiously."
Retrospective data • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
September 01, 2026
Prior Bendamustine Exposure Within 12 Months and Outcomes After CAR-T or Bispecific Antibody Therapy in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Propensity Score-Matched Real-World Analysis
(SOHO 2026)
- "Patients/Participants: Adults aged 18 years or older with DLBCL (ICD-10 C83.3) receiving axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel, epcoritamab, or glofitamab between 2018 and 2025. Prior bendamustine within 12 months was directionally associated with higher 6-month mortality in this propensity-matched real-world cohort, consistent with the T-cell fitness hypothesis. However, no outcome was statistically significant, and the signal attenuated at 12 months, suggesting dilution by bispecific antibody recipients or limited follow-up capture. Larger prospective analyses are needed to define optimal washout intervals before T-cell-dependent immunotherapy."
Bispecific • CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
September 18, 2026
B-Cell Lymphomas, Version 4.2026, NCCN Clinical Practice Guidelines In Oncology.
(PubMed, J Natl Compr Canc Netw)
- "Pirtobrutinib (a highly selective noncovalent BTK inhibitor) and CAR T-cell therapy (brexucabtagene autoleucel or lisocabtagene maraleucel) have emerged as effective treatment options for refractory or progressive disease after prior treatment with covalent BTK inhibitors. This selection from NCCN Guidelines for B-Cell Lymphomas focuses on the recommendations for the diagnosis and treatment of MCL."
Clinical guideline • Journal • NCCN guideline • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • TP53
November 06, 2024
A Proof-of-Principle of Split-Course Bridging Radiotherapy (SC-BRT) Prior to CAR T-Cell Therapies for Relapsed or Refractory B-Cell Lymphomas: A Phase 1a Pilot Cohort
(ASH 2024)
- P1 | "The feasibility outcome was achieved, as all pts successfully received SC-BRT and standard cyclophosphamide/fludarabine LD followed by commercial lisocabtagene maraleucel (n=4) or axicabtagene ciloleucel (n=2)...One patient was treated with steroids and tocilizumab for mild CRS and the patient with grade 5 CRS received steroids, tocilizumab and siltuximab but expired on day +6...This is the first reported delivery of any form of RT following administration of LD chemotherapy potentially opening the door for novel CART conditioning approaches. Given successful completion of Phase 1a, 14 additional patients are now being recruited to the Phase 1b expansion cohort (9 already accrued, data not presented) to confirm safety, assess preliminary outcomes and explore possible immune augmentation."
CAR T-Cell Therapy • P1 data • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • PTPRC
August 08, 2025
NKTR-255 Enhances Complete Response Following CD19 CAR-T in Patients with Relapsed/Refractory Large B-cell Lymphoma.
(PubMed, Blood Adv)
- P2/3 | "In this phase 2, randomized, double-blind, placebo-controlled, multicenter study of NKTR-255 versus placebo following CD19 CAR T-cell therapy, eligible patients with R/R LBCL were treated with one of two FDA-approved CAR T-cell products, axicabtagene ciloleucel (axi-cel) or lisocabtagene maraleucel (liso-cel). NKTR-255 was well-tolerated, safe, and augmented CR6 for LBCL patients. Based on the findings, additional confirmatory studies with NKTR-255 as adjuvant treatment to CAR T-cell, including other cellular therapies, are warranted (ClinicalTrials.gov number NCT05664217)."
Clinical • Journal • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD8
April 27, 2023
Lisocabtagene maraleucel (liso-cel) in R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Primary analysis of TRANSCEND CLL 004.
(ASCO 2023)
- P1/2 | "Background: In patients (pts) with R/R CLL/SLL that progressed on BTKi and failed venetoclax (ven)-based regimens, achieving CR with current treatment is uncommon...In the safety set, rate of any-grade CRS was 84.6% (gr 3, 8.5%; no gr 4/5) and neurological events (NE) was 45.3% (gr 3, 17.9%; gr 4, 0.9%; no gr 5); 69.2% received tocilizumab and/or corticosteroids for CRS/NEs... Liso-cel demonstrated durable CR/CRi, high uMRD rates, and a manageable safety profile in pts with heavily pretreated, high-risk R/R CLL/SLL and high unmet need. Clinical trial information: NCT03331198. >an (%) [95% CI]; bMedian (95% CI), mo."
Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Rare Diseases • Small Lymphocytic Lymphoma
May 04, 2023
Health-related quality of life in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with liso-cel in TRANSCEND CLL 004
(ICML 2023)
- P1/2 | "Introduction: Patients (pt) with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), especially those with progression on Bruton tyrosine kinase inhibitors (BTKi) and venetoclax failure, have limited treatment options and poor pt-reported outcomes (PRO)/health-related quality of life (HRQOL). Liso-cel either improved or maintained HRQOL from baseline in pts with heavily pretreated R/R CLL/SLL. Meaningful improvements were achieved in the key CLL symptom of fatigue and overall QOL."
Clinical • HEOR • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma
November 06, 2024
Lisocabtagene Maraleucel (liso-cel) Combined with Ibrutinib (ibr) for Patients (pts) with Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): Primary Results from the Open-Label, Phase 1/2 Transcend CLL 004 Study
(ASH 2024)
- P1/2, P2/3 | "Background : In TRANSCEND CLL 004 (NCT03331198), monotherapy with liso-cel, an autologous, CD19-directed CAR T cell product (100 × 106 CAR+ T cells [dose level (DL) 2]), resulted in 43% ORR and 18% CR/CR with incomplete marrow recovery (CRi) rate per IRC in pts with third-line or later R/R CLL/SLL who had PD on Bruton tyrosine kinase inhibitor (BTKi) and failed venetoclax (Siddiqi T, et al. Conclusions : Combined liso-cel + ibr demonstrated substantial efficacy with deep remissions (86% ORR, 45% CR rate, and 86% blood uMRD rate) and manageable safety in pts with R/R CLL/SLL. Though comparisons should be made with caution and there were differences in disease characteristics between cohorts, liso-cel + ibr showed a numerically higher ORR/CR rate and lower gr ≥ 3 CRS/NE rates vs liso-cel monotherapy, supporting the combination as a promising new therapeutic strategy for pts with R/R CLL/SLL."
Clinical • P1/2 data • Anemia • Atrial Fibrillation • Cardiovascular • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Hypertension • Infectious Disease • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Small Lymphocytic Lymphoma • IGH • PLCG2 • TP53
October 28, 2021
Phase 1 TRANSCEND CLL 004 study of lisocabtagene maraleucel in patients with relapsed/refractory CLL or SLL.
(PubMed, Blood)
- P1/2 | "Patients had a median of 4 (range, 2‒11) prior therapies (100% had ibrutinib; 65% had venetoclax) and 83% had high-risk features including mutated TP53 and del(17p). Safety and efficacy were similar between dose levels. The phase 2 portion of the study is ongoing at 100×106 CAR+ T cells."
Clinical • Journal • P1 data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Inflammation • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • CD19 • TP53
November 03, 2023
Lisocabtagene Maraleucel (liso-cel) in R/R CLL/SLL: 24-Month Median Follow-up of TRANSCEND CLL 004
(ASH 2023)
- P1/2 | "Background: Patients with R/R CLL/SLL who experience intolerance to or disease progression after Bruton tyrosine kinase inhibitor (BTKi) and venetoclax treatment have no established standard of care and poor outcomes, indicating a critical unmet need...The rate of any-grade cytokine release syndrome (CRS) was 85% (grade 3, 8%; no grade 4/5) and neurological events (NE) was 45% (grade 3, 18%; grade 4, 1%; no grade 5); 69% received tocilizumab and/or corticosteroids for CRS/NEs... With longer follow-up, liso-cel continued to demonstrate durable CR/CRi, high uMRD rates, and a manageable safety profile in patients with heavily pretreated, high-risk R/R CLL/SLL. The safety results from longer follow-up were similar to those reported in the primary analysis with no new safety signals and were consistent across age groups."
B Cell Lymphoma • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • IGH • TP53
September 01, 2026
Corticosteroids With or Without Interleukin 6-Directed Therapy for the Management of Immune Effector Cell–Associated Neurotoxicity Syndrome: A Meta-Analysis
(SOHO 2026)
- " A systematic search of PubMed, ClinicalTrials.gov, and conference proceedings (2017–2025) was performed using the terms ICANS, CAR-T, IL-6, corticosteroid, tocilizumab, siltuximab, anakinra, axicabtagene, tisagenlecleucel, and lisocabtagene. The combination of corticosteroids with tocilizumab does not significantly improve ICANS rates or severity over either strategy. Costimulatory domains remain one of the strongest predictors of ICANS toxicity. Randomized, product-stratified trials are urgently needed to define optimal ICANS-prevention protocols."
Retrospective data • Oncology • IL6 • TNFA
June 10, 2023
Lisocabtagene maraleucel in chronic lymphocytic leukaemia and small lymphocytic lymphoma (TRANSCEND CLL 004): a multicentre, open-label, single-arm, phase 1-2 study.
(PubMed, Lancet)
- P1/2 | "A single infusion of liso-cel was shown to induce complete response or remission (including with incomplete marrow recovery) in patients with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma, including patients who had experienced disease progression on a previous BTK inhibitor and venetoclax failure. The safety profile was manageable."
Journal • P1/2 data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Rare Diseases • Small Lymphocytic Lymphoma
September 01, 2026
A Real-World Study of the Effectiveness and Safety of Post-Tafasitamab Chimeric Antigen Receptor T-Cell Therapy in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
(SOHO 2026)
- " This retrospective, US and EU physician-abstracted medical chart review study collected data for adults with R/R DLBCL who received tafasitamab (±lenalidomide) and subsequent CAR-T in second-line (2L), 3L, or 4L...CAR-T therapies administered were axicabtagene ciloleucel (65.1%), followed by lisocabtagene maraleucel (21.9%) and tisagenlecleucel (13.0%)... This large, real-world study indicates that prior exposure to tafasitamab does not appear to compromise the effectiveness or safety of subsequent CAR-T therapy in patients with R/R DLBCL. These real-world study findings support the sequencing strategy of tafasitamab followed by CAR-T. Funding: This study was funded by Incyte Corporation."
CAR T-Cell Therapy • Clinical • IO biomarker • Real-world • Real-world evidence • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19
August 14, 2023
Lisocabtagene maraleucel (liso-cel) in R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): primary analysis of TRANSCEND CLL 004
(IWCLL 2023)
- P1/2 | "Introduction: In patients with relapsed or refractory (R/R) CLL/ SLL that progressed on Bruton tyrosine kinases inhibitor (BTKi) and failed venetoclax-based regimens, achieving complete response (CR) with current treatment is uncommon...In the safety set, rate of any-grade cytokine release syndrome (CRS) was 84.6% (grade 3, 8.5%; no grade 4/5) and neurological events (NE) was 45.3% (grade 3, 17.9%; grade 4, 0.9%; no grade 5); 69.2% received tocilizumab and/or corticosteroids for CRS/NEs... Liso-cel demonstrated durable CR/CRi, high uMRD rates, and a manageable safety profile in patients with heavily pretreated, high-risk R/R CLL/SLL and high unmet need."
Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma
November 04, 2025
A phase 1b trial of the EZH2 inhibitor tazemetostat combined with CAR T cell therapy in B cell lymphomas
(ASH 2025)
- "4 patients had TP53 mutation or deletion(31%), and of the 7 DLBCL patients, 4 had high-grade myc translocation (57%) and 3 were transformedfrom indolent lymphomas (43%).Following tazemetostat pre-treatment and bridging, 5 patients received axi-cel (38%), 5 liso-cel (38%), 2tisa-cel (15%), and 1 brexu-cel (8%). Addition of the EZH2 inhibitor tazemetostat to the CAR T pre-collection, bridging, and post-infusion periods is feasible, and without early evidence of adverse impact on safety. Initial efficacy data isencouraging but requires additional patients and follow up. Preliminary correlative findings suggest apositive impact of tazemetostat oral administration on the endogenous immune system, tumormicroenvironment, and T cell product in patients."
CAR T-Cell Therapy • IO biomarker • P1 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Indolent Lymphoma • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia • CD4 • CD8 • MYC • TP53
May 04, 2023
FOURTH GENERATION HUCART19-IL18 PRODUCES DURABLE RESPONSES IN LYMPHOMA PATIENTS PREVIOUSLY RELAPSED/REFRACTORY TO ANTI-CD19 CAR T-CELL THERAPY
(ICML 2023)
- "The median age is 65 years (53–74), 77% male, 92% had prior anti-CD19 CART (axi-cel 6, tisa-cel 4, brex-cel 1, tisa-cel+liso-cel 1) with 67% relapsed and 33% refractory to prior CART...CRS was seen in 7 (58%) pts (G1 in 4, G2 in 2, G3 in 1) and ICANS in 2 (17%) pts (G1 in 1, G2 in 2), which were transient/reversible with 3 (25%) pts requiring tocilizumab... HuCART19-IL18 therapy results in durable responses in pts with CD19+ NHL who are R/R to prior 2nd generation anti-CD19 CART. Enrollment continues at DL4 with protocol amendment to include CD19+ B-ALL pts."
CAR T-Cell Therapy • Clinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IL18
September 01, 2026
Real-World Outcomes of CD19 CAR T-Cell Therapies in Follicular Lymphoma: A Comparative Analysis of Axicabtagene Ciloleucel, Lisocabtagene Maraleucel, and Tisagenlecleucel
(SOHO 2026)
- "Safety outcomes included CRS or pyrexia within 30 days, ICANS, infections, neutropenia, and tocilizumab requirement. In this large real-world analysis of FL patients treated with CD19 CAR T-cell therapy, all three products demonstrated durable survival with toxicity profiles consistent with prior clinical trial experience. Differences in CRS, neurotoxicity, and supportivecare requirements highlight the importance of individualized product selection and post–CAR T-cell therapy monitoring. These findings provide important real-world context to inform clinical decisionmaking, and further highlight the need for prospective studies with longer follow-up."
CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology
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
May 04, 2023
LISOCABTAGENE MARALEUCEL (LISO-CEL) IN R/R CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)/SMALL LYMPHOCYTIC LYMPHOMA (SLL): PRIMARY ANALYSIS OF TRANSCEND CLL 004
(ICML 2023)
- P1/2 | "Introduction: Achieving durable CR with current treatment is uncommon in patients (pts) with R/R CLL/SLL that progressed on BTKi and failed venetoclax (ven)-based treatment...In the safety set, rate of any-grade CRS was 84.6% (gr 3, 8.5%; no gr 4/5) and neurological events (NE) was 45.3% (gr 3, 17.9%; gr 4, 0.9%; no gr 5); 69.2% received tocilizumab and/or corticosteroids for CRS/NEs... Liso-cel demonstrated durable CR/CRi, high uMRD rates, and a manageable safety profile in pts with heavily pretreated, high-risk R/R CLL/SLL and high unmet need. Encore Abstract - previously submitted to ASCO 2023"
Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma
August 08, 2026
Contemporary Management of Relapsed or Refractory Chronic Lymphocytic Leukemia.
(PubMed, J Clin Oncol)
- "Second-generation cBTKi (acalabrutinib, zanubrutinib) continuous therapy provides durable disease control with improved tolerability over ibrutinib, whereas continuous venetoclax monotherapy or FD venetoclax-rituximab achieves high response rates and prolonged remission, with retreatment feasible for selected patients. Noncovalent BTKis (ncBTKis) such as pirtobrutinib offer meaningful activity in patients previously exposed to cBTKi. Cellular therapies, particularly lisocabtagene maraleucel, have demonstrated substantial efficacy in heavily pretreated patients, and allogeneic hematopoietic cell transplantation remains an option for select individuals with double-class refractory disease...With broadening treatment options for RR CLL/SLL, optimal sequencing requires consideration of disease biology, depth and duration of prior response, comorbidities, toxicity profiles, patient preferences, and logistical factors. As therapeutic options expand, individualized treatment..."
IO biomarker • Journal • Review • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • Small Lymphocytic Lymphoma • Transplantation • TP53
December 03, 2023
Phase 2 Study of CD19 CAR T Cells with a Fully Human Binder for Large B-Cell Lymphoma in Relapse or Progression after a Murine Binder-Bearing CD19 CAR T-Cell Therapy
(ASH 2023)
- P1 | "Pts received lymphodepletion (LD) with cyclophosphamide 300 mg/m2/d and fludarabine 30 mg/m2/d for 3 days...Prior CD19 CAR T-cell product type was lisocabtagene maraleucel, n=4 (50%); axicabtagene ciloleucel, n= 3 (37%); or tisagenlecleucel, n=1...CONCLUSIONIn LBCL pts with disease relapse or progression after a first CD19 CAR T-cell therapy, we observed low response rates and lack of durable responses after treatment with the fully human scFv-bearing product JCAR021, prompting early study termination. Lower CAR T-cell expansion during manufacturing in CAR-exposed pts suggest pre-existing T-cell dysfunction as a potential mechanism of failure."
CAR T-Cell Therapy • P2 data • Preclinical • Acute Kidney Injury • B Cell Lymphoma • Cerebral Hemorrhage • CNS Disorders • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Nephrology • Non-Hodgkin’s Lymphoma • Oncology • Renal Disease • CD8
September 01, 2026
Real-World Incidence and Management of Cytokine Release Syndrome Following CAR-T Therapy in B-Cell Lymphoma: A Systematic Review
(SOHO 2026)
- "New agents such as anakinra (IL-1 inhibitor) and cilgavimab/tixagevimab (for infection-related CRS) are emerging, with tocilizumab and corticosteroids still being the cornerstones. CRS is a relatively small but serious adverse reaction of CAR-T therapy. Early intervention, standardized grading, and emerging therapies (eg, anakinra, prophylaxis) improve safety. Additional prospective studies are required to further optimize protocols and minimize morbidity."
CAR T-Cell Therapy • Clinical • Cytokine release syndrome • Real-world • Real-world evidence • Review • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
September 01, 2023
Lisocabtagene Maraleucel (liso‑cel) in R/R Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): Primary Analysis of the Phase 1/2, Single‑Arm, Multicenter TRANSCEND CLL 004 Study
(SOHO 2023)
- P1/2 | "Primary endpoint was CR and CR with incomplete marrow recovery (CRi) rate by independent review committee per 2018 international workshop on CLL criteria in the prespecified subset of efficacy-evaluable patients with disease progression on BTKi and venetoclax failure (primary efficacy analysis set [PEAS]) at DL2 (null hypothesis [H0]:≤5%)...In the safety set, rate of any-grade cytokine release syndrome (CRS) was 84.6% (gr 3, 8.5%; no gr 4/5) and neurological events (NE) was 45.3% (gr 3, 17.9%; gr 4, 0.9%; no gr 5); 69.2% received tocilizumab and/or corticosteroids for CRS/NEs... Liso-cel demonstrated durable CR/CRi, high uMRD rates, and manageable safety profile in patients with heavily pretreated, high-risk R/R CLL/SLL."
Clinical • P1/2 data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma
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