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DRUG:

Yescarta (axicabtagene ciloleucel)

i
Other names: FKC876, FKC-876, anti-CD19-CAR PBL, anti-cluster of differentiation 19 (CD19)-CAR PBL, FKC 876, KTE-C19 CAR, anti-CD19 chimeric antigen receptor transduced T cells, KTEC19, KTE-C19, KTE-C19 chimeric antigen receptor T cell therapy
Company:
Cabaret Biotech, Fosun Kite, Gilead, National Cancer Institute
Drug class:
CD19-targeted CAR-T immunotherapy
Related drugs:
2d
Emerging role of lisocabtagene maraleucel chimeric antigen receptor-T cell in nodal and gastrointestinal follicular lymphoma. (PubMed, World J Gastroenterol)
Comparative insights highlight the advantages of liso-cel over other CAR-T cell products, such as axicabtagene ciloleucel and tisagenlecleucel in terms of toxicity, logistics, and outpatient feasibility. With ongoing improvements in manufacturing, accessibility, and biomarker development, liso-cel is well-positioned to become a central component in the evolving treatment paradigm for FL. However, challenges remain regarding durability of response, cost, and access, which warrant careful discussion.
Review • Journal • IO biomarker
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T)
3d
Endothelial dysfunction and proinflammatory state determine severe hematotoxicity and inferior outcome of CAR-T therapy. (PubMed, Hemasphere)
To identify predictive biomarkers, we performed flow cytometry and multiplex assays before and early after CAR-T infusion on 78 patients (ide-cel n = 31; axi-cel n = 24; and cilta-cel n = 23) undergoing CAR-T therapy. Baseline sIL-2R and sVCAM-1 demonstrated robust predictive value for prolonged neutropenia, severe infections, and mortality independently of key clinical variables such as the underlying disease and CAR-T product. Integration of these markers improves existing models and can help to refine risk assessment and guide individualized patient management in CAR-T therapy.
Journal • IO biomarker
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IL2RA (Interleukin 2 receptor, alpha) • VCAM1 (Vascular Cell Adhesion Molecule 1)
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Yescarta (axicabtagene ciloleucel) • Abecma (idecabtagene vicleucel) • Carvykti (ciltacabtagene autoleucel)
4d
PiNACLE-H2H: A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy (clinicaltrials.gov)
P3, N=400, Recruiting, Lyell Immunopharma, Inc. | Not yet recruiting --> Recruiting
Enrollment open
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Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • rondecabtagene autoleucel (LYL314)
5d
ODIN: Optimizing lymphoDepletion to Improve Outcomes In Patients Receiving Cell Therapy With Yescarta (clinicaltrials.gov)
P1, N=40, Recruiting, University Health Network, Toronto | Trial completion date: Jun 2027 --> Sep 2027 | Trial primary completion date: Jun 2025 --> Sep 2027
Trial completion date • Trial primary completion date
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CD20 negative
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cyclophosphamide • Yescarta (axicabtagene ciloleucel)
5d
NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Yescarta® (Axicabtagene Ciloleucel) or Post-Breyanzi® (Lisocabtagene Maraleucel) in Subjects With Relapsed/Refractory Large B-cell Lymphoma (clinicaltrials.gov)
P1, N=24, Not yet recruiting, Washington University School of Medicine | Trial completion date: Apr 2028 --> Aug 2028 | Initiation date: Oct 2025 --> Feb 2026 | Trial primary completion date: Jul 2027 --> Nov 2027
Trial completion date • Trial initiation date • Trial primary completion date
|
Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Hyleukin-7 (efineptakin alfa)
8d
Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov)
P2, N=27, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Oct 2026 --> Jan 2027 | Trial primary completion date: Oct 2025 --> Jan 2026
Trial completion date • Trial primary completion date
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JAK1 (Janus Kinase 1) • CRP (C-reactive protein)
|
Yescarta (axicabtagene ciloleucel) • itacitinib (INCB039110)
1m
Comparative Analysis of Lymphodepletion Regimens in CART-19 Treatment for Relapsed/Refractory Diffuse Large B Cell Lymphoma. (PubMed, Transplant Cell Ther)
Within the limitations of the size of our study and its retrospective nature, flu/cy and bendamustine LD resulted in similar ORR, PFS and OS; however, bendamustine had less hematologic toxicity. Bendamustine can be a viable alternative LD agent for CART-19 therapy for DLBCL, especially in patients with a compromised performance status.
Journal
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CRP (C-reactive protein)
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cyclophosphamide • Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • bendamustine • fludarabine IV
1m
Exploring CD19-targeted Immunotherapy Strategies for Human B-cell Lymphoma. (PubMed, Arch Razi Inst)
There are several FDA-approved anti-CD19 CAR-T cells, including Axicabtagene Ciloleucel, Tisagenlecleucel, and Lisocabtagene Maraleucel, as well as anti-CD19 monoclonal antibodies (mABs), such as loncastuximab tesirine and tafasitamab...Blinatumomab, the inaugural FDA-approved antibody to be produced using BiTE technology, has demonstrated notable benefits in clinical trials investigating its use in the treatment of B-cell acute lymphoblastic leukemia (B-ALL)...Furthermore, we engaged in a discourse on the various treatment options concerning CD19 targeting, accompanied by an exposition of the pertinent clinical studies. In this regard, the efficacy, safety, and limitations of each option were thoroughly delineated.
Review • Journal
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CD20 (Membrane Spanning 4-Domains A1) • TNFRSF8 (TNF Receptor Superfamily Member 8) • CD79B (CD79b Molecule) • CD52 (CD52 Molecule)
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Blincyto (blinatumomab) • Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • Zynlonta (loncastuximab tesirine-lpyl) • Monjuvi (tafasitamab-cxix)
1m
Effectiveness of axicabtagene ciloleucel versus conventional treatments as first-line therapy for high-risk large B-cell lymphoma: an external comparator study. (PubMed, BMC Cancer)
In the present study, we leveraged real-world data as a source for external comparator to present clinically meaningful evidence on the comparative effectiveness of axi-cel for treatment of high-risk LBCL.
Clinical • Journal
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MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
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Yescarta (axicabtagene ciloleucel)
1m
Liquid biopsy-directed therapy in primary bone lymphoma: Venetoclax-Pola-R-CHP and CAR-T achieve molecular remission: a case report. (PubMed, Curr Med Res Opin)
The patient received molecularly guided therapy with Pola-R-CHP (polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, prednisone) plus venetoclax, achieving complete metabolic remission. Due to the persistent MEF2B and TET2 mutations in ctDNA indicated MRD positive, which prompted she received consolidative CAR-T therapy (axicabtagene ciloleucel)...The BCL2 inhibitor venetoclax has shown good therapeutic effects on DLBCL overexpressing BCL2. An integrated approach incorporating these strategies may improve outcomes for this rare lymphoma subtype.
Journal • Liquid biopsy • IO biomarker
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TET2 (Tet Methylcytosine Dioxygenase 2)
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MYC rearrangement + BCL2 rearrangement • TET2 mutation
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Venclexta (venetoclax) • Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • Yescarta (axicabtagene ciloleucel) • prednisone • Polivy (polatuzumab vedotin-piiq)
2ms
Clinical Impact of LAG3 Single-Nucleotide Polymorphism in DLBCL Treated with CAR-T Cell Therapy. (PubMed, Int J Mol Sci)
LAG3 rs870849 may affect treatment outcome in CAR-T cell therapy, with favorable outcomes in T455 carriers. Specific combinations of CTLA4 and LAG3 germline variants may cooperate to affect the response to CAR-T cell therapy.
Journal • IO biomarker
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LAG3 (Lymphocyte Activating 3)
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Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T)
2ms
Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy (clinicaltrials.gov)
P1, N=17, Completed, NeoImmuneTech | Recruiting --> Completed | N=57 --> 17 | Trial completion date: Feb 2026 --> Mar 2025
Trial completion • Enrollment change • Trial completion date
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Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • Hyleukin-7 (efineptakin alfa)