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DRUG:

Breyanzi (lisocabtagene maraleucel)

i
Other names: anti-CD19/EGFRt/4-1BB/zeta modified CAR CD8+ and CD4+ T lymphocyte therapy, JCAR 017, liso-cel, JCAR-017, JCAR017, anti-CD19-EGFRt-4-1BB-zeta modified CAR CD8+ and CD4+ T lymphocyte therapy, CD19-CAR T cell immunotherapy, CD19 specific CAR T cells also expressing an EGFRt
Company:
BMS
Drug class:
CD19-targeted CAR-T immunotherapy
Related drugs:
1d
Lisocabtagene Maraleucel, Nivolumab and Ibrutinib for the Treatment of Richter's Transformation (clinicaltrials.gov)
P2, N=9, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting | N=20 --> 9
Enrollment closed • Enrollment change
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clonoSEQ®
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Opdivo (nivolumab) • Imbruvica (ibrutinib) • cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • fludarabine IV
15d
Phase 2 Trial of Lisocabtagene Maraleucel for Minimal Residual Disease in Patients With Large B-cell Lymphoma (clinicaltrials.gov)
P2, N=50, Active, not recruiting, M.D. Anderson Cancer Center | Suspended --> Active, not recruiting
Enrollment closed • Minimal residual disease
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BCL2 (B-cell CLL/lymphoma 2)
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Foresight CLARITY™
|
Breyanzi (lisocabtagene maraleucel)
19d
Enrollment change • Minimal residual disease
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BCL2 (B-cell CLL/lymphoma 2)
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Foresight CLARITY™
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Breyanzi (lisocabtagene maraleucel)
21d
Trial suspension • Minimal residual disease
|
BCL2 (B-cell CLL/lymphoma 2)
|
Foresight CLARITY™
|
Breyanzi (lisocabtagene maraleucel)
24d
Naïve CD4+ T-cells and disease status at CART infusion correlate with clinical outcomes in real-world large B-cell lymphoma patients receiving second-line CAR T therapy. (PubMed, Nat Commun)
Axicabtagene ciloleucel (axi-cel) and lisocabtagene maraleucel (liso-cel) are standard-of-care second-line therapies for relapsed or refractory large B-cell lymphomas, yet clinical and immunological predictors of durable benefit remain poorly defined. Greater CART expansion, enrichment for naïve CD8+ CAR+ T-cells, and lower PD1 expression at day 7 post-infusion are associated with response. Thus, these findings highlight the efficacy of second-line CART and identify disease and immune-related predictors of long-term response.
Clinical data • Journal • Real-world evidence • PD(L)-1 Biomarker • IO biomarker
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CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule)
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Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel)
1m
Outcomes and salvage strategies for large B-cell lymphoma progressing after second-line CAR T-cell therapy: A DESCAR-T study from the LYSA group. (PubMed, Hemasphere)
We conducted a multicenter retrospective study using the French DESCAR-T registry, including patients with LBCL who relapsed after 2L CAR T-cell therapy with axicabtagene ciloleucel or lisocabtagene maraleucel. This study represents the first real-world analysis of outcomes after relapse following 2L CAR T-cell therapy. Despite the more frequent incorporation of BsAbs into the therapeutic landscape, overall prognosis and treatment efficacy remain dismal, highlighting the urgent need for innovative therapeutic strategies and dedicated prospective trials in this emerging double-refractory population.
Journal
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CRP (C-reactive protein)
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Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel)
1m
Enrollment open
|
cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • nemtabrutinib (MK-1026)
1m
Phase 2 Trial of Lisocabtagene Maraleucel for Minimal Residual Disease in Patients With Large B-cell Lymphoma (clinicaltrials.gov)
P2, N=10, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
Enrollment open • Minimal residual disease
|
BCL2 (B-cell CLL/lymphoma 2)
|
Foresight CLARITY™
|
Breyanzi (lisocabtagene maraleucel)
1m
Circulating Tumor DNA Assessment of Disease Response in Large B-Cell Lymphoma: Lisocabtagene Maraleucel Versus Autologous Stem Cell Transplantation Standard Therapy. (PubMed, J Clin Oncol)
Liso-cel achieved deeper, more durable molecular clearance by ctDNA, consistent with superior EFS and PFS versus ASCT for second-line LBCL treatment. ctDNA-MRD provided prognostic value beyond PET, supporting its role as a complementary biomarker for treatment response and relapse prediction.
Journal • Circulating tumor DNA
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PhasED-Seq™ ctDNA assay
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Breyanzi (lisocabtagene maraleucel)
2ms
New P4 trial
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Breyanzi (lisocabtagene maraleucel) • lisaftoclax (APG-2575)
2ms
Impaired hematopoiesis affects apheresis and CAR T-cell product composition and treatment response. (PubMed, Transfusion)
These findings highlight the importance of early leukapheresis, ideally before intensive treatments, to optimize T-cell yield, product quality, and therapeutic efficacy.
Journal
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CD8 (cluster of differentiation 8)
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Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • HD-CAR-1
2ms
Trial initiation date
|
cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • nemtabrutinib (MK-1026)