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Lisocabtagene maraleucel

Generic Name
Lisocabtagene maraleucel
Brand Names
Breyanzi
Drug Type
Biotech
Unique Ingredient Identifier
7K2YOJ14X0
Background

Lisocabtagene maraleucel is a chimeric antigen receptor (CAR) T-cell therapy, similar to brexucabtagene autoleucel and axicabtagene ciloleucel. Lisocabtagene maraleucel is a genetically modified autologous T-cell therapy that targets CD19, the B-lymphocyte surface antigen B4.

CAR T-cell therapy has changed the treatment of B-cell lymphomas, significantly increasing survival rates over standard therapy. However, data on the efficacy of CAR T-cell therapies on less severe forms of B-cell lymphoma are lacking. Despite the adverse reactions, the majority of patients given lisocabtagene maraleucel reported an overall increase in quality of life over a 1 year period.

Lisocabtagene maraleucel was granted FDA approval on 5 February 2021 and EC approval on 5 April 2022. It was later granted Health Canada approval on 6 May 2022.

Indication

Lisocabtagene maraleucel is indicated to treat adults with relapsed or refractory large B-cell lymphoma after ≥2 systemic therapies, diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma.

Associated Conditions
Grade 3b Follicular Lymphoma, High-grade B Cell Lymphoma (HGBCL), Primary Mediastinal (Thymic) Large B Cell Lymphoma (PMBCL), Refractory Diffuse Large B Cell Lymphoma (DLBCL), Refractory Large B-cell Lymphoma, Relapsed Diffuse Large B-cell Lymphoma (DLBCL)

NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma

Phase 1
Recruiting
Conditions
Refractory Diffuse Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
Recurrent Grade 3b Follicular Lymphoma
Refractory Grade 3b Follicular Lymphoma
Refractory Primary Mediastinal Large B-Cell Lymphoma
Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma
Recurrent Primary Mediastinal Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Interventions
Drug: Polymer-conjugated IL-15 Receptor Agonist NKTR-255
Procedure: X-Ray Imaging
Procedure: Echocardiography
Procedure: Multigated Acquisition Scan
Procedure: Bone Marrow Biopsy
Procedure: Bone Marrow Aspiration
Procedure: Lumbar Puncture
Procedure: Computed Tomography
Procedure: Positron Emission Tomography
Procedure: Biospecimen Collection
Procedure: Biopsy
First Posted Date
2022-05-03
Last Posted Date
2025-01-20
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
24
Registration Number
NCT05359211
Locations
🇺🇸

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy

Phase 1
Recruiting
Conditions
Refractory High Grade B-Cell Lymphoma
Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Refractory Diffuse Large B-cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
Interventions
First Posted Date
2021-10-13
Last Posted Date
2024-02-22
Lead Sponsor
NeoImmuneTech
Target Recruit Count
57
Registration Number
NCT05075603
Locations
🇺🇸

Duke Cancer Institute, Durham, North Carolina, United States

🇺🇸

City of Hope, Duarte, California, United States

🇺🇸

Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center, Detroit, Michigan, United States

and more 1 locations

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

Phase 2
Recruiting
Conditions
Lymphoma, Non-Hodgkin
Interventions
First Posted Date
2020-01-29
Last Posted Date
2025-04-29
Lead Sponsor
Celgene
Target Recruit Count
276
Registration Number
NCT04245839
Locations
🇺🇸

UCLA Medical Centre-Santa Monica, Santa Monica, California, United States

🇺🇸

University Of Colorado Cancer Center, Aurora, Colorado, United States

🇺🇸

Yale Cancer Center, New Haven, Connecticut, United States

and more 56 locations

A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL)

Phase 1
Terminated
Conditions
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Non-Hodgkin
Interventions
First Posted Date
2018-11-16
Last Posted Date
2024-08-15
Lead Sponsor
Celgene
Target Recruit Count
21
Registration Number
NCT03743246
Locations
🇺🇸

Local Institution - 167, Redwood City, California, United States

🇺🇸

Local Institution - 161, Seattle, Washington, United States

🇺🇸

Local Institution - 165, Houston, Texas, United States

and more 16 locations

A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)

Phase 2
Completed
Conditions
Immunoproliferative Disorders
Lymphoma, B-Cell
Lymphoproliferative Disorders
Immune System Disorder
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphatic Diseases
Neoplasms
Interventions
First Posted Date
2018-11-16
Last Posted Date
2025-02-27
Lead Sponsor
Juno Therapeutics, a Subsidiary of Celgene
Target Recruit Count
104
Registration Number
NCT03744676
Locations
🇺🇸

Local Institution - 0061, San Antonio, Texas, United States

🇺🇸

Local Institution - 0057, Los Angeles, California, United States

🇺🇸

Local Institution - 0101, Southfield, Michigan, United States

and more 20 locations

MT2017-45: CAR-T Cell Therapy for Heme Malignancies

First Posted Date
2018-08-22
Last Posted Date
2025-04-02
Lead Sponsor
Masonic Cancer Center, University of Minnesota
Target Recruit Count
144
Registration Number
NCT03642626
Locations
🇺🇸

Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States

Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma

Phase 2
Completed
Conditions
Lymphoma, Non-Hodgkin
Interventions
First Posted Date
2018-04-02
Last Posted Date
2024-12-27
Lead Sponsor
Celgene
Target Recruit Count
113
Registration Number
NCT03484702
Locations
🇮🇹

Local Institution - 402, Milan, Italy

🇬🇧

Local Institution - 501, London, United Kingdom

🇬🇧

Local Institution - 502, Manchester, Lancashire, United Kingdom

and more 17 locations
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