Tecartus (brexucabtagene autoleucel)
/ Gilead, Fosun Kairos, Fosun Pharma, Kite Pharma
- LARVOL DELTA
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November 03, 2023
GLOBRYTE: A Phase III, Open-Label, Multicenter, Randomized Trial Evaluating Glofitamab Monotherapy in Patients with Relapsed or Refractory Mantle Cell Lymphoma
(ASH 2023)
- "Chimeric antigen receptor (CAR) T-cell therapies, such as brexucabtagene autoleucel, have shown promising outcomes, but alternative systemic therapies are still needed in this pt population...A Phase I/II trial of glofitamab monotherapy with step-up dosing (SUD) and obinutuzumab pretreatment (Gpt; 1000 or 2000mg) to mitigate the risk of cytokine release syndrome (CRS) showed high and durable complete response (CR) rates (73.0%) and manageable, mostly low-grade CRS in heavily pretreated pts with R/R MCL (n=37), most of whom had failed prior BTKi therapy (Phillips et al...Study Design and The GLOBRYTE study (GO43878; EU CT: 2023-503206-37-00) is a Phase III, open-label, multicenter, randomized, controlled trial that will evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (biomarkers) of glofitamab monotherapy in pts with R/R MCL, in comparison with an investigator's choice of rituximab + bendamustine (BR) or rituximab + lenalidomide..."
Clinical • Monotherapy • P3 data • Cardiovascular • CNS Disorders • CNS Lymphoma • Epilepsy • Fatigue • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • Secondary Central Nervous System Lymphoma • Vasculitis
September 01, 2026
Therapeutic Implications of TP53 and High-Risk Genomic Alterations in Mantle Cell Lymphoma: A Systematic Review
(SOHO 2026)
- "Cellular immunotherapies demonstrated promising efficacy, with brexucabtagene autoleucel and lisocabtagene maraleucel achieving CR rates of 82% and 74.3%, respectively, in relapsed/refractory disease. Triplet regimens incorporating a BTK inhibitor, venetoclax, and obinutuzumab demonstrated CR rates of up to 88% in early-phase studies... Genomic alterations are important determinants of prognosis and treatment outcomes in MCL. TP53 abnormalities remain the strongest adverse prognostic biomarker. Current evidence supports the increasing role of genomic profiling in routine risk stratification and therapeutic decision-making in MCL."
IO biomarker • Review • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • BIRC3 • CDKN2A • KMT2D • NOTCH1 • TP53
September 26, 2026
MCC-22286: Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)
(clinicaltrials.gov)
- P2 | N=60 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Nov 2028 ➔ Jul 2031 | Trial primary completion date: Nov 2028 ➔ Jul 2031
Minimal residual disease • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology
August 29, 2026
Hepatobiliary Adverse Event Signals Across FDA-Approved CAR-T Cell Therapy Agents: A Pharmacovigilance Analysis of the FDA Adverse Event Reporting System
(ACG 2026)
- "Six agents were analyzed: axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel, brexucabtagene autoleucel, idecabtagene vicleucel, and ciltacabtagene autoleucel, by both generic and proprietary names from respective FDA approval dates. Of 22,486 CAR-T-related adverse event reports, 466 (2.1%) involved hepatobiliary adverse events; all met seriousness criteria (100%), with overall CFR 36.7% (171/466). Tisagenlecleucel had a positive signal (ROR 2.45; 95% CI 2.01-2.97; PRR 2.39; chi-square 69.53; CFR 51.3%), exceeding ciltacabtagene autoleucel (ROR 0.33; Z=10.60, p< 0.001) and brexucabtagene autoleucel (ROR 0.79; Z=5.49, p< 0.001). CD19-targeted agents showed higher disproportionality than BCMA-targeted agents (ROR 2.26; 1.75-2.91; p< 0.001)."
Adverse events • CAR T-Cell Therapy • Hematological Malignancies • Hepatology • Liver Failure
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
Real-World CAR-T Utilization and Competing Mortality Following Covalent BTKi Therapy in Mantle Cell Lymphoma
(SOHO 2026)
- "Since FDA approval of brexucabtagene autoleucel for relapsed/refractory MCL in 2020, limited data have described post-covalent Bruton tyrosine kinase inhibitor (cBTKi) treatment trajectories, chimeric antigen receptor T-cell (CAR-T) therapy utilization, and competing mortality...During follow-up, 14.7% received venetoclax, 12.2% switched cBTKi, and 11.8% received pirtobrutinib. In this real-world MCL cohort, CAR-T therapy utilization after cBTKi initiation was uncommon, and the competing risk of death before CAR-T exceeded CAR-T receipt, particularly among older patients. These findings support further research into factors influencing real-world CAR-T utilization and treatment delivery."
CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
November 04, 2025
Acalabrutinib plus rituximab followed by brexucabtagene autoleucel for frontline treatment of high-risk Mantle Cell Lymphoma: The window-3 clinical trial
(ASH 2025)
- P1 | "Our results in this pilot WINDOW-3 trial indicate that AR followed by brexu-cel treatment ishighly effective with induction of high rates of undetectable MRD state in patients with previouslyuntreated high-risk MCL. Additional follow-up is needed to assess durability of responses and impact ofacalabrutinib maintenance on long-term safety and efficacy. While the incidence of high-grade CRS andICANS were similar to prior results with brexu-cel in high-risk relapsed or refractory MCL patients,strategies to mitigate these toxicities warrant further investigation."
Clinical • IO biomarker • Dermatology • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Thrombocytopenia • KMT2D • NOTCH1 • NSD2 • SMARCA4 • TP53 • UBR5
September 30, 2025
Outcome of Patients with Mantle Cell Lymphoma after Failure of Anti-CD19 CAR-T Cell Therapy: A Descar-T Study By Lysa Group.
(PubMed, Blood Adv)
- "Brexucabtagene autoleucel (brexu-cel) is the anti-CD19 CAR-T therapy approved for the treatment of relapse/refractory (RR) mantle cell lymphoma (MCL)...Forty-nine patients received salvage therapy: 16 lenalidomide ± rituximab (Len/R2), 13 immunochemotherapy (ICT), 8 Bruton tyrosine kinase inhibitor ± venetoclax (BTKi/Ven), 7 a bispecific T-cell engager (TCE), 3 another targeted therapy, and 2 radiations...Notably, none of the TCE responders have relapsed to date (DOR of 100%). Our series highlights the poor outcomes of MCL patients following CAR-T failure and suggest a potential benefit of bispecific antibodies in this population."
IO biomarker • Journal • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • TP53
April 11, 2025
ZUMA-8: A Phase 1 Study of Brexucabtagene Autoleucel in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia.
(PubMed, Blood)
- P1 | "Patients with ≥2 prior lines of therapy (including a BTK inhibitor) underwent leukapheresis, followed by optional bridging therapy, then conditioning chemotherapy (fludarabine/cyclophosphamide) before infusing 1×106 (Cohort 1) or 2×106 (Cohort 2) anti-CD19 CAR T cells/kg. Patients in Cohort 3 (low tumor burden), and Cohort 4A (ibrutinib pre-treated closely to the apheresis) received 1×106 cells/kg...CAR T-cell expansion occurred in 4 patients (27%), with an apparent weak inverse correlation with absolute lymphocyte count (ALC) prior to the apheresis. Brexu-cel did not have any new safety signals in R/R CLL, and CAR T-cell expansion and responses occurred in patients with low tumor burden."
Journal • P1 data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology
March 16, 2025
Itacitinib for the Prevention of IEC Therapy-Associated CRS: Results From the Two-Part Phase 2 INCB 39110-211 Study.
(PubMed, Blood)
- P2 | "Patients in part 1 received once-daily itacitinib 200 mg 3 days before IEC therapy (axicabtagene ciloleucel [axi-cel], brexucabtagene autoleucel, or tisagenlecleucel) through Day 26, with guidelines for use of other CRS/ICANS interventions. Importantly, itacitinib did not impact IEC therapy efficacy (objective response rate at 6 months: 39.1% for itacitinib 200 mg bid vs 26.1% for placebo). Trial registration: clinicaltrials.gov; #NCT04071366."
Journal • P2 data • Hematological Disorders • Hematological Malignancies • 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 05, 2021
A Phase II Study of Prophylactic Anakinra to Prevent CRS and Neurotoxicity in Patients Receiving CD19 CAR T Cell Therapy for Relapsed or Refractory Lymphoma
(ASH 2021)
- P2 | "CD19 CAR products included axicabtagene (23 pts; 74%), tisagenlecleucel (4 pts; 13%) and brexucabtagene (4 pts; 13%). Early use of IL-1 receptor inhibitor anakinra appears to be safe and feasible, and reduces the rates of both severe CRS and ICANS with the comparable response rates in adult pts with R/R B-cell lymphoma receiving CD19 CAR T cells. The overall severe CRS and ICANS rates were 6% each with relatively low utilization of tocilizumab (29%) and corticosteroids (19%). In pts receiving axicabtagene, the rate of severe ICANS was 4%."
CAR T-Cell Therapy • Clinical • P2 data • Critical care • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Inflammation • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19
June 08, 2022
Three-Year Follow-Up of KTE-X19 in Patients With Relapsed/Refractory Mantle Cell Lymphoma, Including High-Risk Subgroups, in the ZUMA-2 Study.
(PubMed, J Clin Oncol)
- "These data, representing the longest follow-up of CAR T-cell therapy in patients with MCL to date, suggest that KTE-X19 induced durable long-term responses with manageable safety in patients with relapsed/refractory MCL and may also benefit those with high-risk characteristics."
Journal • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology
November 06, 2024
Primary Analysis of ZUMA-2 Cohort 3: Brexucabtagene Autoleucel (Brexu-Cel) in Patients (Pts) with Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Who Were Naive to Bruton Tyrosine Kinase Inhibitors (BTKi)
(ASH 2024)
- P2 | "Prior anti-CD20, anthracycline, and bendamustine therapies were received by 100%, 79%, and 27% of pts, respectively; 48% had prior autologous stem cell transplantation, and 36% received bridging therapy. Additionally, no new safety signals were detected, with a low rate of Gr ≥3 CRS and an expected rate of Gr ≥3 neurological events. These results support the continued use of brexu-cel in the R/R MCL setting, including pts naive to BTKi therapy."
Clinical • Hematological Malignancies • Infectious Disease • Inflammation • Lymphoma • Mantle Cell Lymphoma • Musculoskeletal Diseases • Oncology • Orthopedics • Septic Shock • TP53
November 04, 2025
Brexucabtagene autoleucel (Brexucel) as a consolidation therapy in B-cell acute lymphoblastic leukemia (B-ALL) post HCVAD/minihcvd-inotuzumab-blinatumomab regimens: Initial Results of a prospective Phase 2 trial.
(ASH 2025)
- P1/2 | "Leukapheresis could be followed by further chemo-immunotherapy and then standard lymphodepletion (LD) with fludarabine-cyclophosphamide beforebrexucel infusion...Adverse events included cytokine release syndrome (CRS) in 8 (57%) pts (all grade 1); 3 pts neededsingle dose tocilizumab... From Dec 2024-July 31 2025, 28 pts have had leukapheresis,18 pts were infused and 14 pts with afollow-up (FU) >1 month post brexucel infusion were included in this report. The median age of theinfused pts was 35 years (range 19-77), and 5 pts (36%) were ³60 years of age. Ten pts (71%) receivedbrexcuel as FL consolidation therapy for adverse genomics, 3 FL pts (21%) had persistent (n=2)/recurrent(n=1) MRD, and 1 (7%) pt had R/R ALL."
Clinical • IO biomarker • P2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Inflammation • Leukemia • KMT2A • TP53
November 04, 2025
IL18-armored CAR T cells in relapsed/refractory B cell acute lymphoblastic leukemia
(ASH 2025)
- P1 | "NEJM 2025), and here we share our initial experiencetreating patients with R/R B cell acute lymphoblastic leukemia (ALL).MethodsIn a single center, first in human clinical trial utilizing huCART19-IL18 (NCT04684563), adult patients withR/R CD19+ ALL were eligible, including those with CNS disease and those with relapses after priorCART19, blinatumomab, and allogeneic transplant (alloHCT)...Subjects then receivedlymphodepleting (LD) fludarabine and cyclophosphamide followed by huCART19-IL18 infusion.ResultsAs of Aug...Subjects had a median of 5 (3-11) priorlines of therapy including alloHCT in 4 patients, blinatumomab in 4 (3 as salvage for post-alloHCT relapse),and brexucabtagene autoleucel in 2...Three patients received tocilizumab for CRS, and 1 received corticosteroids andanakinra for ICANS...All treated patients withadequate follow-up achieved early MRD-negative CR (including in the CNS), and there have been norelapses or deaths with a median follow-up of 15.1..."
CAR T-Cell Therapy • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • CNS Disorders • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • IL18
November 03, 2023
A Phase II Trial of Prophylactic Anakinra to Prevent Neurotoxicity in Patients Receiving Anti-CD19 CAR T-Cell Therapy for Relapsed or Refractory Lymphoma: Final Results from Cohort 2
(ASH 2023)
- P2 | "Rates of severe (≥ grade 3) ICANS remain high with axicabtagene (axi-cel) and brexucabtagene (brexu-cel) at > 30%...The median age of the cohort was 65yrs (range: 24 – 81yrs) and patients received axi-cel (19 pts; 63%), brexu-cel (5 pts; 17%), lisocabtagene (4 pts; 13%) and tisagenlecleucel (2 pts; 7%)...23 patients (77%) received tocilizumab and 18 (60%) received steroids for CRS and/or ICANS... Early use of prophylactic anakinra was safe, feasible and reduced the rate of severe ICANS without affecting efficacy in adult patients receiving anti-CD19 CAR-T for r/r B-cell lymphoma. Rates of severe ICANS were very similar between cohorts 1 and 2; at 9.7% and 10% in the entire cohorts, respectively, and 11% and 12.5% in patients treated with CD28-containing CARs, respectively. The risk-adapted dosing of anakinra likely contributed to the low rates of severe ICANS in this study."
CAR T-Cell Therapy • Clinical • IO biomarker • P2 data • B Cell Lymphoma • CNS Disorders • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
November 03, 2023
Real-World Outcomes of Brexucabtagene Autoleucel (Brexu-cel) for Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL): A CIBMTR Subgroup Analysis of High-Risk Characteristics
(ASH 2023)
- "Pts with Ki-67 PI ≥ 50% were more likely to receive Bruton's tyrosine kinase inhibitor (BTKi) (92% vs 81%) and bridging therapy (52% vs 37%), but less likely to receive bendamustine (47% vs 62%). These real-world findings with 12 mo of follow-up suggest that outcomes of brexu-cel treatment are largely consistent, including a high CR rate, regardless of ZUMA-2 eligibility or the high-risk feature subgroups analyzed. Although pts without deletion of TP53/17p appeared to have longer OS than pts with deletion of TP53/17p, the data further support brexu-cel as the standard of care across pts with R/R MCL, including those with high-risk features. An updated dataset is planned to be analyzed and results can be presented at the conference."
Clinical • Real-world • Real-world evidence • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Oncology • Thrombocytopenia • TP53
April 27, 2023
Real-world outcomes of brexucabtagene autoleucel (brexu-cel) for relapsed or refractory (R/R) mantle cell lymphoma (MCL): A CIBMTR subgroup analysis by prior treatment.
(ASCO 2023)
- "Sponsored by Pharmaceutical/Biotech Company, Kite, a Gilead Company, NCI grant: National Cancer Institute (CIDR [U24 CA233032]). These early findings suggest that real-world outcomes of brexu-cel are consistent regardless of prior BTKi, bendamustine, or autoHCT. Use of brexu-cel in earlier lines may help achieve a higher CR rate. Further studies with longer follow-up are warranted to contextualize response rates in relation to long-term clinical benefits of brexu-cel."
Clinical • Real-world • Real-world evidence • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Oncology • TP53
September 01, 2026
Successful Treatment of CD19+ Mixed-Phenotype Acute Leukemia With Brexucabtagene Autoleucel Plus Tyrosine Kinase Inhibitor
(SOHO 2026)
- "She underwent induction therapy with a tyrosine kinase inhibitor (TKI), cyclophosphamide, vincristine, and dexamethasone for 2 cycles as well as intrathecal methotrexate and cytarabine, resulting in complete remission (CR) with detectable breakpoint cluster region–Abelson murine leukemia viral oncogene homolog 1 fusion (BCR::ABL1) transcripts by quantitative polymerase chain reaction (qPCR; 0.02%) in bone marrow (BM). In an effort to eliminate minimal residual disease, the patient received 2 cycles of blinatumomab with a TKI, which was complicated by grade 1 cytokine release syndrome (CRS) without improvement in BCR:: ABL1 (post-treatment BM qPCR 0.06%)...Treatment was complicated by grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS; handwriting) treated with dexamethasone and grade 2 CRS (fever and hypotension) treated with tocilizumab... This represents the first reported use of anti-CD19 CAR T-cell therapy for MPAL and supports its feasibility in..."
Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR
September 01, 2026
Pirtobrutinib-First vs Brexucabtagene Autoleucel–First Sequencing Post Covalent BTK Inhibitor Failure in Mantle Cell Lymphoma: A Propensity-Matched Real-World Analysis
(SOHO 2026)
- "Among patients with post-cBTKi MCL, brexu-cel-first was associated with better OS compared with pirtobrutinib-first. After multivariable adjustment for patient fitness indicators, including hemoglobin and infection history, the OS advantage became nonsignificant. These findings highlight a favorable patient selection bias toward fit patients being chosen for CAR-T therapy and should be considered when sequencing treatment in post-cBTKi MCL."
Clinical • Real-world • Real-world evidence • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology
September 01, 2026
CD19-Directed Chimeric Antigen Receptor T-Cell Therapy in Patients With HIV-Associated Relapsed/Refractory Lymphoma: A Systematic Review
(SOHO 2026)
- P1 | "Interventions: Twenty-six patients received axicabtagene ciloleucel; one received brexucabtagene autoleucel. Lymphodepleting fludarabine/cyclophosphamide (dose-adjusted for HIV and cytopenias) preceded infusion... CAR T-cell therapy is safe and potentially efficacious in PLWHA with R/R NHL, with toxicity and survival outcomes comparable to HIV-negative populations. Ongoing trials like AMC-112 (NCT05077527) will further define safety and long-term outcomes in this underserved population. AMC: AIDS Malignancy Consortium, ART: antiretroviral therapy, CAR: chimeric antigen receptor, CD: cluster of differentiation, CR: complete response, CRS: cytokine release syndrome, DLBCL: diffuse large B-cell lymphoma, FDA: United States Food and Drug Administration, ICANS: immune effector cell–associated neurotoxicity syndrome, NHL: non-Hodgkin lymphoma, OS: overall survival, PLWHA: people living with HIV/AIDS, PR: partial response, R/R: relapsed/refractory, VL: viral load."
CAR T-Cell Therapy • Clinical • Review • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD4
May 13, 2022
THREE-YEAR FOLLOW-UP OF OUTCOMES WITH KTE-X19IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA IN ZUMA-2
(EHA 2022)
- "Three new Grade 5 AEs occurred, none of which were considered related to study treatment: Salmonella bacteremia (24.9 mo post-infusion), myelodysplastic syndrome (25.2 mo post-infusion), and acute myeloid leukemia (37.5 mo post-infusion). Conclusion These data represent the longest follow-up of CAR T-cell therapy in pts with MCL to date and suggest that KTE-X19 induces durable long-term responses with manageable safety and low late relapse potential in R/R MCL."
Clinical • Acute Myelogenous Leukemia • CNS Disorders • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Leukemia • Lymphoma • Mantle Cell Lymphoma • Myelodysplastic Syndrome • Neutropenia • Oncology • Pneumonia • Respiratory Diseases
December 16, 2022
Subgroup Analyses of Kte-X19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy, in Adult Patients (Pts) with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL) in Zuma-3
(TCT-ASTCT-CIBMTR 2023)
- "Results from a pooled analysis of all Phase 1 and 2 pts treated at the pivotal dose (N=78) (median follow-up of 29.7 mo [range, 20.7-58.3]) were similar, further supporting the subgroup outcomes in Phase 2 pts ( Table ). Conclusions : Adult pts with R/R B-ALL benefitted from KTE-X19, with manageable safety, regardless of prior exposure to blinatumomab or prior alloSCT, but survival appeared better in pts without these prior therapies and in earlier lines of therapy, with limited pt numbers in some subgroups."
Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Inflammation • Leukemia • Oncology • Transplantation
July 04, 2023
CD19 CAR T-cell therapy and prophylactic anakinra in relapsed or refractory lymphoma: phase 2 trial interim results.
(PubMed, Nat Med)
- "Among 31 treated patients, 74% received axicabtagene ciloleucel, 13% received brexucabtagene ciloleucel and 4% received tisagenlecleucel. The overall disease response rate was 77% with 65% complete response rate. These initial results show that prophylactic anakinra resulted in a low incidence of ICANS in patients with lymphoma receiving anti-CD19 CAR T-cell therapy and support further study of anakinra in immune-related neurotoxicity syndromes."
CAR T-Cell Therapy • Journal • P2 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
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