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)

Clinical Trials

A Study to Patients With Relapsed/Refractory Follicular Lymphoma Treated With Liso-cel (Lisocabtagene Maraleucel) in the Post Marketing Setting

Recruiting

Conditions: Follicular Lymphoma

Interventions: Biological: Lisocabtagene maraleucel

First Posted Date: 2025-01-27

Last Posted Date: 2025-02-24

Lead Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Target Recruit Count: 300

Registration Number: NCT06794268

Locations: 🇺🇸
CIBMTR, Milwaukee, Wisconsin, United States

A Study of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting

Recruiting

Conditions: Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)

Interventions: Biological: Lisocabtagene maraleucel

First Posted Date: 2025-01-23

Last Posted Date: 2025-02-24

Lead Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Target Recruit Count: 300

Registration Number: NCT06788639

Locations: 🇺🇸
Center for International Blood and Marrow Transplant Research (CIBMTR), Milwaukee, Wisconsin, United States

A Study of Patients With Relapsed/Refractory Mantle Cell Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting

Recruiting

Conditions: Mantle Cell Lymphoma (MCL)

Interventions: Biological: Lisocabtagene maraleucel

First Posted Date: 2025-01-23

Last Posted Date: 2025-02-24

Lead Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Target Recruit Count: 300

Registration Number: NCT06788652

Locations: 🇺🇸
Center for International Blood and Marrow Transplant Research (CIBMTR), Milwaukee, Wisconsin, United States

Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Second Primary Malignancy

Recruiting

Conditions: Chronic Lymphocytic Leukaemia
Multiple Myeloma
Non-Hodgkin Lymphoma

Interventions: Biological: Lisocabtagene maraleucel
Biological: Idecabtagene vicleucel

First Posted Date: 2024-04-10

Last Posted Date: 2025-04-11

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 50

Registration Number: NCT06357754

Locations: 🇺🇸
Local Institution - 0010, Salt Lake City, Utah, United States
🇺🇸
Local Institution - 0004, Madison, Wisconsin, United States
🇨🇭
Kantonsspital Aarau, Aarau, Switzerland

and more 2 locations

A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma

Phase 3

Not yet recruiting

Conditions: Relapsed or Refractory Follicular Lymphoma

Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Liso-cel
Drug: Vincristine
Drug: Rituximab
Drug: Prednisone
Drug: Bendamustine
Drug: Lenalidomide

First Posted Date: 2024-03-15

Last Posted Date: 2024-03-15

Lead Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Target Recruit Count: 300

Registration Number: NCT06313996

Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome

Phase 2

Recruiting

Conditions: Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma
Recurrent Transformed Non-Hodgkin Lymphoma
Recurrent Transformed Chronic Lymphocytic Leukemia
Refractory Transformed Chronic Lymphocytic Leukemia
Refractory Transformed Non-Hodgkin Lymphoma
Refractory Transformed B-cell Non-Hodgkin Lymphoma
Recurrent Transformed B-Cell Non-Hodgkin Lymphoma
Refractory Transformed

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Drug: Cyclophosphamide
Drug: Fludarabine
Procedure: Leukapheresis
Biological: Lisocabtagene Maraleucel
Procedure: Lymph Node Biopsy
Procedure: Positron Emission Tomography
Drug: Zanubrutinib

First Posted Date: 2023-05-24

Last Posted Date: 2025-04-08

Lead Sponsor: Aseel Alsouqi

Target Recruit Count: 24

Registration Number: NCT05873712

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States
🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Lisocabtagene Maraleucel, Nivolumab and Ibrutinib for the Treatment of Richter's Transformation

Phase 2

Recruiting

Conditions: Richter Syndrome
Recurrent Transformed Chronic Lymphocytic Leukemia
Refractory Transformed Chronic Lymphocytic Leukemia

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Ibrutinib
Biological: Lisocabtagene Maraleucel
Biological: Nivolumab
Procedure: Pheresis
Procedure: Positron Emission Tomography

First Posted Date: 2023-01-05

Last Posted Date: 2025-04-01

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 20

Registration Number: NCT05672173

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Phase 2

Recruiting

Conditions: Primary Mediastinal (Thymic) Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
Transformed Marg Zone Lymph to Diff Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
Grade 3b Follicular Lymphoma
Transformed Follic Lymph to Diff Large B-Cell Lymphoma

Interventions: Biological: Axicabtagene Ciloleucel
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Cyclophosphamide
Biological: Mosunetuzumab
Other: Patient Observation
Drug: Fludarabine
Drug: Polatuzumab Vedotin
Biological: Lisocabtagene Maraleucel
Procedure: Positron Emission Tomography
Biological: Tisagenlecleucel

First Posted Date: 2022-12-01

Last Posted Date: 2024-12-20

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 396

Registration Number: NCT05633615

Locations: 🇺🇸
Highlands Oncology Group - Fayetteville, Fayetteville, Arkansas, United States
🇺🇸
Highlands Oncology Group - Rogers, Rogers, Arkansas, United States
🇺🇸
Highlands Oncology Group, Springdale, Arkansas, United States

and more 73 locations

Low Dose Radiation as Bridging Therapy in Relapsed B-Cell Non-Hodgkin Lymphoma

Phase 1

Recruiting

Conditions: Mediastinal Large B-cell Lymphoma
High-grade B-cell Lymphoma
Indolent B-Cell Non-Hodgkin Lymphoma
Relapsed Non-Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma
DLBCL - Diffuse Large B Cell Lymphoma
Follicular Lymphoma

Interventions: Radiation: Bridging radiation therapy
Biological: Liso-cel
Radiation: Post-infusion radiation

First Posted Date: 2022-11-17

Last Posted Date: 2024-07-09

Lead Sponsor: University of Nebraska

Target Recruit Count: 33

Registration Number: NCT05621096

Locations: 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States

Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas

Phase 2

Recruiting

Conditions: Refractory B-Cell Non-Hodgkin Lymphoma
Refractory Aggressive B-cell Lymphomas
Aggressive B-cell NHL
De Novo or Transformed Indolent B-cell Lymphoma
High-Grade B-Cell Lymphoma, Nos
Grade 3b Follicular Lymphoma
T Cell/Histiocyte-rich Large B-cell Lymphoma
C-MYC/BCL6 Double-Hit High-Grade B-Cell Lymphoma
Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL, Nos Genetic Subtypes

Interventions: Drug: ACALABRUTINIB
Drug: LISOCABTAGENE MARALEUCEL
Drug: Lymphodepleting chemotherapy

First Posted Date: 2022-10-17

Last Posted Date: 2024-04-04

Lead Sponsor: Patrick C. Johnson, MD

Target Recruit Count: 27

Registration Number: NCT05583149

Locations: 🇺🇸
Beth-Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

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