Lisocabtagene maraleucel

BIOLOGICAL18 trials

Sponsors

Celgene Corp., Bristol-Myers Squibb Services Unlimited Company, Juno Therapeutics, a Subsidiary of Celgene, NeoImmuneTech, Fred Hutchinson Cancer Center

Conditions

Aggressive B-cell NHLC-MYC/BCL2 Double-Hit High-Grade B-Cell LymphomaC-MYC/BCL6 Double-Hit High-Grade B-Cell LymphomaChronic Lymphocytic LeukaemiaChronic Lymphocytic Leukemia (CLL)DLBCL, Nos Genetic SubtypesDe Novo or Transformed Indolent B-cell LymphomaDefined by parent protocol. The study will enroll all adult and paediatric subjects who received at least one genetically modified T cells infusion in a previous Celgene sponsored study.

Phase 1

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

CompletedNCT05075603

NeoImmuneTechRecurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified +2

Start: 2021-08-06End: 2025-03-12Updated: 2025-10-23

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

Active, not recruitingNCT05359211

Fred Hutchinson Cancer CenterRecurrent Diffuse Large B-Cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Recurrent Grade 3b Follicular Lymphoma +6

Start: 2022-12-08End: 2026-09-04Updated: 2026-03-20

ST-067 in Combination With CD19-Directed CAR T-Cell Therapy (Liso-cel) in Relapsed/Refractory Large B-Cell Lymphoma

RecruitingNCT07098364

Fred Hutchinson Cancer CenterRecurrent Diffuse Large B-Cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Recurrent Grade 3b Follicular Lymphoma +9

Start: 2025-12-27End: 2043-10-04Target: 33Updated: 2026-01-14

Phase 2

Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)

CompletedNCT03483103

Juno Therapeutics, a Subsidiary of CelgeneLymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Nonhodgkin +1

Start: 2018-07-27End: 2022-12-01Updated: 2023-12-20

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)

CompletedNCT03744676

Juno Therapeutics, a Subsidiary of CelgeneImmune System Disorder, Immunoproliferative Disorders, Lymphatic Diseases +7

Start: 2018-11-29End: 2023-09-22Updated: 2025-02-27

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

Active, not recruitingNCT05583149

Patrick C. Johnson, MDAggressive B-cell NHL, C-MYC/BCL2 Double-Hit High-Grade B-Cell Lymphoma, C-MYC/BCL6 Double-Hit High-Grade B-Cell Lymphoma +10

Start: 2023-03-01End: 2029-03-01Updated: 2026-01-29

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

RecruitingNCT05633615

SWOG Cancer Research NetworkDiffuse Large B-Cell Lymphoma, Grade 3b Follicular Lymphoma, Primary Mediastinal (Thymic) Large B-Cell Lymphoma +4

Start: 2023-06-12End: 2030-06-30Target: 396Updated: 2026-02-02

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

RecruitingNCT05672173

City of Hope Medical CenterRecurrent Transformed Chronic Lymphocytic Leukemia, Refractory Transformed Chronic Lymphocytic Leukemia, Richter Syndrome

Start: 2023-06-02End: 2026-09-10Target: 20Updated: 2025-12-15

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

RecruitingNCT05873712

Aseel AlsouqiRecurrent Transformed B-Cell Non-Hodgkin Lymphoma, Recurrent Transformed Chronic Lymphocytic Leukemia, Recurrent Transformed Non-Hodgkin Lymphoma +5

Start: 2023-07-28End: 2026-12-31Target: 24Updated: 2026-03-03

LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH GENE-MODIFIED T CELLS

RecruitingCTIS2023-504201-36-00

Celgene Corp.Defined by parent protocol. The study will enroll all adult and paediatric subjects who received at least one genetically modified T cells infusion in a previous Celgene sponsored study.

Start: 2018-12-21Target: 214Updated: 2025-10-27

A PHASE 2, OPEN-LABEL, SINGLE-ARM, MULTICOHORT, MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF JCAR017 IN ADULT SUBJECTS WITH RELAPSED OR REFRACTORY INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL) (Transcend FL)

Not yet recruitingCTIS2024-510966-18-00

Celgene Corp.Relapsed or refractory indolent B-cell Non-Hodgkin Lymphoma (NHL)

Target: 99Updated: 2025-08-25

Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Not yet recruitingNCT07194980

Fred Hutchinson Cancer CenterRecurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Start: 2026-04-01End: 2029-10-20Target: 20Updated: 2026-01-09

The CAROLYN Trial: Lisocabtagene Maraleucel as First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients

RecruitingCTIS2025-521144-38-00

Bristol-Myers Squibb Services Unlimited CompanyPrimary Central Nervous System Lymphoma

Start: 2025-12-23Target: 31Updated: 2025-11-21

Phase 3

A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy

RecruitingNCT07188558

Lyell Immunopharma, Inc.Diffuse Large B Cell Lymphoma (DLBCL), Diffuse Large B Cell Lymphoma Refractory, Diffuse Large B Cell Lymphoma Relapsed +6

Start: 2026-01-12End: 2032-01-01Target: 400Updated: 2026-03-04

Unknown Phase

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

RecruitingNCT06357754

Bristol-Myers SquibbChronic Lymphocytic Leukaemia, Multiple Myeloma, Non-Hodgkin Lymphoma

Start: 2023-10-06End: 2038-10-06Target: 50Updated: 2026-01-22

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

RecruitingNCT06788652

Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyMantle Cell Lymphoma (MCL)

Start: 2025-02-04End: 2044-09-30Target: 300Updated: 2025-02-24

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

RecruitingNCT06788639

Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyChronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)

Start: 2025-02-04End: 2044-06-30Target: 300Updated: 2025-02-24

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

RecruitingNCT06794268

Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyFollicular Lymphoma

Start: 2025-02-04End: 2044-08-31Target: 300Updated: 2025-02-24

Related Papers

A phase II multi-institutional Study evaluating the safety and efficacy of the combination of lisocabtagene maraleucel and zanubrutinib in patients with richter transformation

Blood2025-11-03

A Phase 1 study evaluating NT-I7 (efineptakin alfa), a long-acting human IL-7, post-tisagenlecleucel (tisa-cel), post-axicabtagene ciloleucel (axi-cel), or post-lisocabtagene maraleucel (liso-cel) in Relapsed/Refractory large B-cell lymphoma

Blood2025-11-03

INSIGHT: A baseline laboratory profile independently predicts outcomes and demonstrates superiority of lisocabtagene maraleucel (liso-cel) over standard of care (SOC) in second-line (2L) large B-cell lymphoma (LBCL) regardless of baseline profile

Blood2025-11-03

Optimizing post–chimeric antigen receptor (CAR) T cell monitoring: Evidence across lisocabtagene maraleucel (liso-cel) pivotal clinical trials and real-world experience.

Journal of Clinical Oncology2025-05-28

Lisocabtagene maraleucel for R/R LBCL in patients not intended for HSCT: final results of the phase 2 PILOT study

Blood Advances2025-04-305 citations

Real-World (RW) Outcomes of Lisocabtagene Maraleucel (liso-cel) As Second-Line (2L) Therapy in Patients (pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL): First Results from the Center for International Blood and Marrow Transplant Research (CIBMTR) Registry

Blood2024-11-056 citations

Comparative efficacy of lisocabtagene maraleucel in the PILOT study <i>versus</i> second-line chemotherapy regimens in the real world

Haematologica2024-10-311 citations

OUTREACH: phase 2 study of lisocabtagene maraleucel as outpatient or inpatient treatment at community sites for R/R LBCL

Blood Advances2024-09-3013 citations

Lisocabtagene Maraleucel as Second-Line Therapy for R/R Large B-Cell Lymphoma in Patients Not Intended for Hematopoietic Stem Cell Transplant: Final Analysis of the Phase 2 PILOT Study

Blood2023-11-0214 citations

Postinfusion Monitoring Health Care Resource Utilization and Costs By Site of Care Among Inpatients and Outpatients with Relapsed or Refractory Large B-Cell Lymphoma Who Received Second-Line Treatment with Lisocabtagene Maraleucel in the TRANSFORM and PILOT Clinical Trials

Blood2023-11-021 citations

Cytokine Release Syndrome and Neurological Event Management Resource Use and Costs Among Patients with Relapsed or Refractory Large B-Cell Lymphoma Who Received Second-Line Lisocabtagene Maraleucel Treatment in TRANSFORM and PILOT

Blood2023-11-02

Lisocabtagene maraleucel for second-line relapsed or refractory large B-cell lymphoma: patient-reported outcomes from the PILOT study

Haematologica2023-08-3011 citations

Results from Outreach: A Phase 2 Study of Lisocabtagene Maraleucel (Liso-cel) Administered As Outpatient (Outpt) or Inpatient (Inpt) Treatment in the Community/Nonuniversity Setting in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL)

Blood2022-11-155 citations

Comparative Effectiveness of Lisocabtagene Maraleucel (Liso-cel) in PILOT in Patients (Pt) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) for Whom Transplant Was Not Intended (TNI) Versus Conventional Second-Line (2L) Chemotherapy Regimens in the Real World

Blood2022-11-153 citations

A Phase Ib Open-Label Study Evaluating the Safety and Efficacy of NKTR-255 in Combination with CD19-Directed CAR-T Cell Therapy in Patients with Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL)

Blood2022-11-152 citations

Lisocabtagene Maraleucel (Liso-cel) in Patients with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) Treated As Outpatients or Inpatients in the Community/Nonuniversity Setting: Patient-Reported Outcomes/Health-Related Quality of Life from the Outreach Study

Blood2022-11-152 citations

A novel polymer-conjugated human IL-15 improves efficacy of CD19-targeted CAR T-cell immunotherapy

Blood Advances2022-11-0422 citations

Expansion of CAR-T Cells in Vivo With Long-Acting Interleukin-7 Analog

Oncology Times2022-08-17

Lisocabtagene maraleucel as second-line therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation (PILOT): an open-label, phase 2 study.

2022-07-12170 citations

Lisocabtagene maraleucel (liso-cel) as second-line (2L) therapy for R/R large B-cell lymphoma (LBCL) in patients (pt) not intended for hematopoietic stem cell transplantation (HSCT): Primary analysis from the phase 2 PILOT study.

Journal of Clinical Oncology2022-06-015 citations

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