Last update 21 Nov 2024

Lisocabtagene maraleucel

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Autologous CAR-T

Synonyms

CD19-directed chimeric antigen receptor T cell therapy, Lisocabtagene maraleucel (USAN/INN), anti-CD19-EGFRt-4-1BB-zeta modified CAR CD8+ and CD4+ T lymphocyte therapy

+ [6]

Target

CD19

Mechanism

CD19 modulators(B-lymphocyte antigen CD19 modulators), T lymphocyte replacements

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Mantle-Cell LymphomaChronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma+ [28]

Inactive Indication

Pre B-cell acute lymphoblastic leukemiaRecurrent B Acute Lymphoblastic Leukemia

Originator Organization

Fred Hutchinson Cancer Research Center

Bristol Myers Squibb Co.

Active Organization

Bristol-Myers Squibb Pharma EEIG

Juno Therapeutics, Inc.

Celgene Corp.

+ [3]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (05 Feb 2021),

Diffuse Large B-Cell LymphomaFollicular LymphomaHigh grade B-cell lymphoma+ [1]

RegulationAccelerated assessment (US), Orphan Drug (EU), Priority Review (US), Accelerated Approval (US)

Gene Sequence

Sequence Code 133555

Source: *****

Sequence Code 133567

Source: *****

Sequence Code 133531

Source: *****

Sequence Code 171111

Source: *****

Sequence Code 133586

Source: *****

Sequence Code 133534

Source: *****

Clinical Trials associated with Lisocabtagene maraleucel

NCT06313996 / Not yet recruitingPhase 3

A Global Randomized Multicenter Phase 3 Trial to Compare the Efficacy and Safety of Lisocabtagene Maraleucel (JCAR017/BMS-986387) to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma (TRANSFORM FL)

The purpose of this study is to evaluate the efficacy and safety of Liso-cel compared to standard of care in adults with Relapsed or Refractory Follicular Lymphoma.

Start Date29 Mar 2024

Sponsor / Collaborator

Juno Therapeutics, Inc.

[+1]

NCT06205290 / WithdrawnPhase 3

A Global Phase 3, Randomized, Open-label, Multi-center Trial Designed to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options (Idelalisib + Rituximab or Bendamustine + Rituximab) in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), Whose Disease Has Failed Treatment With Both BTKi and BCL2i Targeted Therapies (A Double Class Exposed Population)

The purpose of this study is to compare the efficacy and safety of liso-cel vs Investigator's Choice options (idelalisib + rituximab or bendamustine + rituximab) in adult participants with R/R CLL or SLL, whose disease has failed treatment with both BTKi and BCL2i targeted therapies.

Start Date16 Jan 2024

Sponsor / Collaborator

Juno Therapeutics, Inc.

[+1]

NCT05934448 / RecruitingPhase 2IIT

A Phase II Trial of Pembrolizumab in Combination With Chimeric Antigen Receptor Therapy in Patients With Relapsed/Refractory Primary Mediastinal B-cell Lymphoma

This research study is evaluating the combination of drugs, pembrolizumab with chimeric antigen receptor (CAR) T-cell therapy, as a possible treatment for primary mediastinal B-cell lymphoma that has recurred after prior treatment.
The names of the study drugs involved in this study are:
- Pembrolizumab
Standard treatment will include:
CAR T-cell therapy (either axicabtagene-ciloleucel or lisocabtagene maraleucel)
Cyclophosphamide
Fludarabine

Start Date15 Nov 2023

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

100 Clinical Results associated with Lisocabtagene maraleucel

100 Translational Medicine associated with Lisocabtagene maraleucel

100 Patents (Medical) associated with Lisocabtagene maraleucel

158

Literatures (Medical) associated with Lisocabtagene maraleucel

01 Nov 2024·Transplantation and Cellular Therapy

Real-World Analysis of Barriers to Timely Administration of Chimeric Antigen Receptor T Cell (CAR T) Therapy in Diffuse Large B-cell Lymphoma

Article

Author: Elder, Jennifer ; Boseman, Victoria ; Hu, Bei ; Copelan, Edward A ; Jacobs, Ryan W ; Jennings, Rebecca D ; Vaidya, Rakhee ; Howard, Dianna S ; Ghosh, Nilanjan ; Avalos, Belinda ; Moyo, Tamara K ; Park, Steven ; Shroff, Vishal ; Wallander, Michelle ; Pang, Yifan ; Ahmed, Ferdous ; Beam, Travis ; Mesa, Ruben ; Yountz, Melissa ; Wallander, Michelle L ; Ehsan, Hamid

The implementation of chimeric antigen receptor T (CAR T) therapy in the real-world setting is hindered by logistical and financial barriers, impacting timely access to this life-saving treatment. Clinical trials have reported the time from leukapheresis to CAR T cell infusion (vein-to-vein time) but not the time from CAR T referral to infusion (decision-to-vein time). Herein, we report the barriers to CAR T therapy in a real-world setting. We evaluated the factors influencing the decision-to-vein time and explored the association with clinical outcomes in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who received CAR T therapy. We conducted a retrospective study of adult patients with relapsed/refractory DLBCL who underwent consultation for CAR T cell therapy at Levine Cancer Institute and Wake Forest Comprehensive Cancer Center and collected information regarding demographic data, referral type, insurance type, CAR T product, and survival outcomes. The effects of variables on decision-to-vein time were analyzed by Fisher's exact test for categorial variables and Wilcoxon rank-sum test for continuous variables. Survival analyses were performed using Kaplan-Meier and Cox Proportional Hazard models. The study included 142 patients who were referred for CAR T of which 99 patients received CAR T. Median decision-to-vein time was 62 days compared to median vein-to-vein time of 32 days. Patients with private insurance took longer to obtain financial clearance compared to patients with government insurance (median 25 versus 9 days, P < .001). Of those with private insurance (n = 63), 35% needed a single-case agreement (SCA) which led to significant delay in receiving financial clearance (median 50.5 versus 19 days, P < .001) and increased decision-to-vein time (median 75 versus 55 days, P < .001) compared to those who did not need SCA. Decision-to-vein time was significantly different among various products, clinical trial being the shortest (median 47 days, n = 9) and non-conforming products being the longest (median 94.5 days, n = 6) (P< .001). Axi-cel had the shortest median decision-to-vein time at 61 days compared to 81 days with tisa-cel and 85 days with liso-cel. Although delays in receiving CAR T therapy did not impact survival, the median overall survival for patients who were referred for CAR T therapy but did not receive it, was significantly lower than those who received CAR T cell therapy (9.0 versus 21.0 months, P < .001). Decision-to-vein time is a major cause of delay in receiving CAR T therapy. SCAs lead to significant increase in decision-to-vein time leading to delays in CAR T therapy in a real-world setting. Patients who were referred for CAR T but are not able to receive it, have inferior survival compared to CAR T recipients. Our findings underscore the significance of addressing administrative hurdles, such as SCAs and insurance approvals, for timely access to CAR T therapy for patients with DLBCL.

22 Oct 2024·Blood Advances

Optimizing the post-CAR T monitoring period in recipients of axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel

Article

Author: Brower, Jamie ; Chen, Andy I. ; Nastoupil, Loretta J. ; Riedell, Peter A. ; Bachanova, Veronika ; McGuirk, Joseph P. ; Maziarz, Richard T. ; Bishop, Michael R. ; Shah, Gunjan L. ; Perales, Miguel-Angel ; Schuster, Stephen J. ; Ahmed, Nausheen ; Lutfi, Forat ; Porter, David L. ; Wesson, William ; Oluwole, Olalekan O.

AbstractCD19–directed chimeric antigen receptor T-cell (CAR T) therapies, including axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), and lisocabtagene maraleucel (liso-cel), have transformed the treatment landscape for B-cell non-Hodgkin lymphoma, showcasing significant efficacy but also highlighting toxicity risks such as cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS). The US Food and Drug Administration has mandated patients remain close to the treatment center for 4 weeks as part of a Risk Evaluation and Mitigation Strategy to monitor and manage these toxicities, which, although cautious, may add to cost of care, be burdensome for patients and their families, and present challenges related to patient access and socioeconomic disparities. This retrospective study across 9 centers involving 475 patients infused with axi-cel, tisa-cel, and liso-cel from 2018 to 2023 aimed to assess CRS and ICANS onset and duration, as well as causes of nonrelapse mortality (NRM) in real-world CAR T recipients. Although differences were noted in the incidence and duration of CRS and ICANS between CAR T products, new-onset CRS and ICANS are exceedingly rare after 2 weeks after infusion (0% and 0.7% of patients, respectively). No new cases of CRS occurred after 2 weeks and a single case of new-onset ICANS occurred in the third week after infusion. NRM is driven by ICANS in the early follow-up period (1.1% until day 28) and then by infection through 3 months after infusion (1.2%). This study provides valuable insights into optimizing CAR T therapy monitoring, and our findings may provide a framework to reduce physical and financial constraints for patients.

22 Oct 2024·Blood Advances

CD19-directed CART therapy for T-cell/histiocyte–rich large B-cell lymphoma

Article

Author: Ahmed, Nausheen ; Nasrollahi, Elham ; Sauter, Craig ; Hilal, Talal ; Shouval, Roni ; Hamadani, Mehdi ; Maakaron, Joseph ; Iqbal, Madiha ; Modi, Dipenkumar ; Schachter, Levanto G. ; Shadman, Mazyar ; Ahn, Kwang W. ; Fein, Joshua A. ; Awan, Farrukh T. ; Allbee-Johnson, Molly ; Pophali, Priyanka A. ; Herrera, Alex ; Grover, Natalie S. ; Farhan, Shatha

AbstractT-cell/histiocyte–rich large B-cell lymphoma (THRLBCL) is a rare histologic variant of LBCL. Limited data regarding CD19–directed chimeric antigen receptor T-cell (CART) therapy in relapsed/refractory (R/R) THRLBCL suggest poor efficacy. We investigated CART outcomes for R/R THRLBCL through the Center for International Blood and Marrow Transplant Research registry. A total of 58 adult patients with R/R THRLBCL who received commercial CD19-CART therapy between 2018 and 2022 were identified. Most patients (67%) had early relapse of disease (45% primary refractory) with a median of 3 (range, 1-7) prior therapies and were treated with axicabtagene ciloleucel (69%). At median follow-up of 23 months after CART therapy, 2-year overall and progression-free survival were 42% (95% confidence interval [CI], 27-57) and 29% (95% CI, 17-43), respectively. In univariable analysis, poor performance status before CART therapy was associated with higher mortality (hazard ratio, 2.35; 95%CI, 1.02-5.5). The 2-year cumulative incidences of relapse/progression and nonrelapse mortality were 69% and 2%, respectively. Grade ≥3 cytokine release syndrome and immune effector cell–associated neurologic syndrome occurred in 7% and 15% of patients, respectively. In this largest analysis of CD19-CART therapy for R/R THRLBCL, ∼30% of patients were alive and progression free 2 years after CART therapy. Despite a high incidence of progression (69% at 2 years), these results suggest a subset of patients with R/R THRLBCL may have durable responses with CARTs.

211

News (Medical) associated with Lisocabtagene maraleucel

18 Nov 2024

·www.businesswire.com

Foresight Diagnostics to Present New Data on Foresight CLARITY™ Ultra-Sensitive MRD Detection Across Multiple Studies at the 66th American Society of Hematology Annual Meeting

BOULDER, Colo.--( BUSINESS WIRE )-- Foresight Diagnostics , a leader in ultrasensitive minimal residual disease (MRD) testing, today announced the presentation of multiple studies showcasing Foresight CLARITY™ MRD at the upcoming 66 th American Society of Hematology Annual Meeting and Exposition taking place December 7-10 in San Diego, California. The presentations span various lymphoma types and treatment settings, demonstrating the broad applicability of the Foresight CLARITY MRD detection technology for monitoring treatment response and predicting patient outcomes. The studies include collaborations with multiple pharmaceutical companies and research institutions, including AstraZeneca, Bristol Myers Squibb (BMS), Daiichi Sankyo (DSI), Stanford University, Washington University, and others. "These studies add to the growing body of evidence supporting ultra-sensitive MRD testing as a critical tool in lymphoma care and drug development," said David Kurtz, MD, PhD, Chief Medical Officer and Head of Research at Foresight Diagnostics. "We see in these studies that MRD measurement with Foresight CLARITY consistently enables earlier and more accurate treatment response assessment than conventional imaging-based methods. The ability to monitor disease status in real-time with ultra-sensitive MRD assays like Foresight CLARITY may help accelerate clinical trials and lead to more personalized decision-making for patient care." Results utilizing Foresight CLARITY MRD technology are featured in six abstracts, including three that are co-authored by Foresight. Presentation highlights include: LBCL/DLBCL: ctDNA-MRD as a surrogate endpoint for 2L CAR T – Analysis of the Phase 3 TRANSFORM trial in second-line treatment for large B-cell lymphoma (LBCL) reinforced the potential of circulating tumor DNA (ctDNA) as an earlier endpoint for response assessment and assessment of clinical trial results. In the TRANSFORM study, patients receiving lisocabtagene maraleucel (liso-cel) had significantly improved event-free survival compared to standard of care. Consistent with this result, patients receiving liso-cel also demonstrated higher rates of MRD clearance, demonstrating CLARITY's ability to measure differential treatment responses. MRD Response with novel first-line therapy in high-risk DLBCL – Analysis of a Phase 1b trial CC-220-DLBCL-001 combining golcadomide with R-CHOP in previously untreated aggressive B-cell lymphoma showed promising MRD clearance rates. The data demonstrated that 90% of patients achieved MRD negativity at end of treatment with golcadomide 0.4mg + R-CHOP, with strong responses observed even in high-risk patients. These data further support the ongoing Phase 3 GOLSEEK-1 study investigating this novel combination therapy in high-risk 1L LBCL. Enhanced risk stratification by MRD vs. traditional methods – New research investigates the predictive value of the International Prognostic Index (IPI), currently the primary pre-treatment risk assessment tool for DLBCL. The study revealed that pre-treatment IPI scores did not significantly correlate with end-of-treatment MRD status, with MRD testing being a superior predictor of progression-free survival. Follicular Lymphoma: MRD-based response assessment of novel FL therapies – Two studies demonstrated the value of MRD assessment in follicular lymphoma trials, with new treatment approaches showing early clearance. The CD19xCD3 bispecific antibody AZD0486 achieved 89% MRD negativity in relapsed or refractory FL patients by 12 weeks in complete responders. In the 1L setting, the chemotherapy-free combination of mosunetuzumab and polatuzumab vedotin showed similar early MRD clearance, with 7 of 8 complete responders achieving MRD negativity before cycle 3. These results highlight the potential for MRD as an early indicator of therapeutic response in FL clinical trials. PTCL: ctDNA as a prognostic biomarker for T-cell lymphoma – Analysis from the VALENTINE-PTCL01 Phase 2 trial in relapsed/refractory peripheral T-cell lymphoma (PTCL) revealed that patients achieving early, deep ctDNA reduction (>5-fold decrease by Cycle 2 Day 1) experienced significantly longer progression-free survival, establishing ctDNA monitoring as a powerful tool for early response assessment. Information on abstract presentation time and dates can be found below. To meet with Foresight Diagnostics, visit booth #3423 or contact us at BD@foresight-dx.com. Oral Presentations: Circulating Tumor DNA (ctDNA) as an Early Outcome Predictor in Patients with Second-Line Large B-Cell Lymphoma After Lisocabtagene Maraleucel Versus Standard of Care Treatment from the Phase 3, Randomized TRANSFORM Study Presenter: Ash Alizadeh, MD, PhD (Stanford University) Session 628 Date/Time: Saturday, December 7, 2024, 10:45 a.m. Sponsor: Bristol Myers Squibb Co-authored by Foresight Diagnostics Escalating Doses of AZD0486, a Novel CD19xCD3 T-Cell Engager, Result in High Complete Remissions with Rapid Clearance of Minimal Residual Disease in Patients with Relapsed/Refractory Follicular Lymphoma Presenter: Jing-Zhou Hou, MD, PhD (UPMC Hillman Cancer Center) Session 623 Date/Time: Saturday, December 7, 2024, 5 p.m. Sponsor: AstraZeneca Golcadomide (GOLCA) Plus R-CHOP Has High Minimal Residual Disease (MRD) Negativity across High-Risk, Untreated Aggressive B-Cell Lymphoma (a-BCL) Presenter: Jason R. Westin, MD (MD Anderson) Session 627 Date/Time: Sunday, December 8, 2024, 12:30 p.m. Sponsor: Bristol Myers Squibb International prognostic index poorly predicts EOT ctDNA MRD status in DLBCL and has limited impact on its predictive value for outcomes Presenter: Jordan S. Goldstein, MD, MS (Stanford University) Session 626 Date/Time: Sunday, December 8, 2024, 5 p.m. Co-authored by Foresight Diagnostics Poster Presentations: Prediction of Clinical Response by Phased Variants in Circulating Tumor DNA (ctDNA) in the VALENTINE-PTCL01 trial of Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma Presenter: Neha Mehta-Shah, MD, MSCI (Washington University) Abstract #4342, Session 621 Date/Time: Monday, December 9, 2024, 6-8 p.m. Sponsor: Daiichi Sankyo Co-authored by Foresight Diagnostics Mosunetuzumab Plus Polatuzumab Vedotin Induces Early Complete Responses in Previously Untreated High Tumor Burden Follicular Lymphoma Presenter: David A Russler-Germain, MD, PhD (Washington University) Abstract #4414, Session 623 Date/Time: Monday, December 9, 2024, 6-8 p.m. About Foresight Diagnostics Foresight Diagnostics is a privately-held cancer diagnostics company and CLIA-registered laboratory. Its liquid biopsy platform, Foresight CLARITY™, is a novel assay that measures minimal residual disease (MRD) with reported detection limits in parts per million 1. The improved sensitivity of Foresight CLARITY has the potential to provide actionable information to physicians and biopharmaceutical companies to enable more personalized treatment approaches for patients with solid tumor and hematologic malignancies. For more information, please visit foresight-dx.com and follow us on Twitter and LinkedIn. Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use. 1 Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use.

Clinical ResultPhase 3ASH

01 Nov 2024

·www.biospace.com

BMS Delivers Q3 Beat, Raises 2024 Guidance Amid Strong Demand for Legacy and Newer Drugs

iStock, arlutz73 Bristol Myers Squibb’s third-quarter results benefited from sales of its legacy brands Eliquis and Revlimid, as well as growth portfolio products such as Abecma, Breyanzi and Reblozyl. Bristol Myers Squibb on Thursday touted strong year-over-year growth in the third quarter of 2024, with sales handily beating the consensus estimate driven by its legacy and newer products. On the strength of the Q3 performance, BMS raised its full-year revenue guidance, now expecting a year-over-year increase of around 5%—up from its previous forecast of the upper end of low-single-digit growth. The outlook for the company’s full-year diluted earnings-per-share (EPS) was also lifted to $0.75 to $0.95, from the previous range of $0.60 to $0.90. “Our overall business mix is beginning to transform as our growth portfolio is becoming a bigger component,” CEO Christopher Boerner said during an investor call on Thursday, touting the combination of its pipeline—which is approaching several “near-term catalysts”—and a “disciplined focus on expense management.” These factors, Boerner said, are key to the company’s “focus on executing in the near term while laying the groundwork for long-term sustainable growth.” In Q3, BMS reported total global revenues of $11.9 billion–8% year-over-year growth at constant currencies—and a 6% beat versus the consensus estimate of $11.3 billion. In an investor note, William Blair analyst Matt Phipps credited BMS’ strong quarter to the reliable performance of its legacy brands—including Revlimid and Eliquis—and the “traction” of its growth portfolio brands such as Breyanzi, Abecma and Reblozyl, which “all beat consensus estimates.” Truist Securities analyst Srikripa Devarakonda in an investor note said the multiple myeloma drug Revlimid declined “less than anticipated.” Its sales dipped 1% in the quarter to $1.4 billion but still exceeded the consensus of $1.1 billion. The blood thinner Eliquis continues to be BMS’ top-performing asset, jumping 11% year-over-year to bring in just over $3 billion in Q3. BMS’ earnings call was primarily focused on its newly approved schizophrenia therapy Cobenfy, which won the FDA’s nod in September 2024 . Boerner said the drug had “multibillion-dollar potential” and will help the company accelerate its growth, though the company’s optimism appeared to be largely measured. BMO Capital Markets analyst Evan Seigerman in an investor note said that “while we appreciate conservatism in neuropsych, management commentary has been somewhat muted around revenue expectations,” particularly as “launch is expected to be a slow build in schizophrenia.” By contrast, Seigerman expects Alzheimer’s psychosis as a stronger opportunity for Cobenfy “in terms of sentiment.” Cobenfy is currently in Phase III development for this indication. “While we are encouraged by Bristol’s progress in the quarter on top line and expenses, the transformative change Bristol needs will come from its pipeline,” Seigerman wrote. Consensus peak sales estimate for Cobenfy is $5.4 billion. BMS expects to see a “sales ramp” for Cobenfy starting in the second half of 2025, following broad access in Medicare and Medicaid patients, Chief Commercialization Officer Adam Lenkowsky said during Thursday’s investor call.

Phase 3

03 Oct 2024

·www.prnewswire.com

StemCyte's HPC Cord Blood Receives RMAT Designation for Long COVID-19 Treatment

BALDWIN PARK, Calif., Oct. 3, 2024 /PRNewswire/ -- StemCyte announced today that its Hematopoietic Progenitor Cell Cord Blood therapy (HPC Cord Blood) has officially obtained the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the treatment of Long COVID-19 syndrome. StemCyte is one of the few cell therapy companies in the United States to receive the FDA-granted RMAT designation. Continue Reading Long COVID-19 syndrome is a severe and persistent consequence of COVID-19, for which no effective treatment currently exists. StemCyte's HPC Cord Blood is the world's first cord blood cell therapy to receive FDA approval for a Phase II clinical trial specifically for Long COVID-19. The RMAT designation, which was largely based on positive outcomes from the Phase II trial, enables StemCyte to collaborate closely with the FDA to expedite development, gain priority review, and leverage accelerated approval opportunities for future indications. StemCyte receives FDA RMAT for Long COVID-19; HPC Cord Blood therapy enters Phase III to address unmet medical needs. Post this The Phase II clinical trial of HPC Cord Blood was successfully completed within eight months in the United States, achieving full patient enrollment. StemCyte expects to unblind the results soon. The RMAT designation not only brings hope to patients suffering from Long COVID-19 but also expands the potential applications for HPC Cord Blood. Currently, StemCyte is in the planning stages for a Phase III clinical trial under FDA guidance. Significant progress has also been made on the Biologics License Application (BLA) for the HPC Cord Blood product (RegeneCyte), with StemCyte expecting to receive FDA approval by the end of the year to utilize umbilical cord blood-derived hematopoietic stem cells as a treatment for cancers, blood disorders, and immune deficiencies. The FDA's RMAT designation is reserved for products that show breakthrough therapeutic potential and address significant unmet medical needs. According to the FDA, as of June 2024, there have been 279 RMAT applications submitted worldwide, with successful approvals including Kymriah®, Abecma®, and Breyanzi® CAR-T treatments. StemCyte is honored to be the only cell therapy company to achieve this milestone for its HPC Cord Blood. About StemCyte StemCyte is a leader in the field of regenerative medicine, focusing on the development of innovative therapies utilizing cord blood. With a mission to bring advanced cellular therapies to the market, StemCyte is dedicated to improving health outcomes for patients globally. Contact: [email protected] SOURCE StemCyte WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Cell TherapyPhase 2Phase 3

100 Deals associated with Lisocabtagene maraleucel

External Link

KEGG	Wiki	ATC	Drug Bank
D11990	-	L01XX	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diffuse large B-cell lymphoma recurrent	NO	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Diffuse large B-cell lymphoma recurrent	LI	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Diffuse large B-cell lymphoma recurrent	EU	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Diffuse large B-cell lymphoma recurrent	IS	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Primary mediastinal large B-cell lymphoma refractory	NO	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Primary mediastinal large B-cell lymphoma refractory	LI	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Primary mediastinal large B-cell lymphoma refractory	EU	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Primary mediastinal large B-cell lymphoma refractory	IS	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Recurrent Grade 3b Follicular Lymphoma	EU	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Recurrent Grade 3b Follicular Lymphoma	NO	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Recurrent Grade 3b Follicular Lymphoma	LI	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Recurrent Grade 3b Follicular Lymphoma	IS	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Refractory Grade 3b Follicular Lymphoma	EU	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Refractory Grade 3b Follicular Lymphoma	LI	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Refractory Grade 3b Follicular Lymphoma	NO	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Refractory Grade 3b Follicular Lymphoma	IS	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Diffuse Large B-Cell Lymphoma	US	Juno Therapeutics, Inc.	05 Feb 2021
Follicular Lymphoma	US	Juno Therapeutics, Inc.	05 Feb 2021
High grade B-cell lymphoma	US	Juno Therapeutics, Inc.	05 Feb 2021
Mediastinal large B-cell lymphoma	US	Juno Therapeutics, Inc.	05 Feb 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Mantle cell lymphoma recurrent	NDA/BLA	JP	Bristol Myers Squibb Co.	30 Jan 2024
Mantle cell lymphoma recurrent	NDA/BLA	US	Bristol Myers Squibb Co.	30 Jan 2024
Mantle cell lymphoma refractory	NDA/BLA	US	Bristol Myers Squibb Co.	30 Jan 2024
Mantle cell lymphoma refractory	NDA/BLA	JP	Bristol Myers Squibb Co.	30 Jan 2024
Recurrent Follicular Lymphoma	NDA/BLA	US	Bristol Myers Squibb Co.	30 Jan 2024
Recurrent Follicular Lymphoma	NDA/BLA	JP	Bristol Myers Squibb Co.	30 Jan 2024
Refractory Follicular Lymphoma	NDA/BLA	US	Bristol Myers Squibb Co.	30 Jan 2024
Refractory Follicular Lymphoma	NDA/BLA	JP	Bristol Myers Squibb Co.	30 Jan 2024
Chronic lymphocytic leukaemia refractory	NDA/BLA	US	Bristol Myers Squibb Co.	18 Nov 2023
Recurrent Chronic Lymphoid Leukemia	NDA/BLA	US	Bristol Myers Squibb Co.	18 Nov 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03331198 (TRANSCEND CLL 004, ASH2024) Manual	Phase 1/2	Chronic Lymphocytic Leukemia	118	Lisocabtagene MaraleucelLisocabtagene Maraleucel (liso-cel) (DL2 100 × 10^6 + PEAS)	(zweespyanm) = zveakqyeok rxsibazbsu (rdnjjrdilo ) View more	Positive	09 Dec 2024
NCT03331198 (TRANSCEND CLL 004, ASH2024) Manual	Phase 1/2	Chronic Lymphocytic Leukemia	118	Lisocabtagene MaraleucelLisocabtagene Maraleucel (liso-cel)venetoclax (DL2 100 × 10^6 + PEAS + only prior BTKi exposure and were venetoclax naïve)	(zweespyanm) = dwisntllyf rxsibazbsu (rdnjjrdilo ) View more	Positive	09 Dec 2024
ASH2024	Not Applicable	Chronic Lymphocytic Leukemia	-	Lisocabtagene Maraleucel (liso-cel) + Ibrutinib (ibr)	gonpabpufk(mzsnrjjwfl) = Any-gr CRS occurred in 45 (80%) pts (gr ≥ 3, n = 2 [4%]) zxaeublxir (jyrlgmilna ) View more	-	09 Dec 2024
ASH2024	Not Applicable	Chronic Lymphocytic Leukemia	-	Lisocabtagene Maraleucel (liso-cel)		-	09 Dec 2024
ASH2024	Not Applicable	Refractory Follicular Lymphoma	-	Lisocabtagene Maraleucel (liso-cel)	nfsilpphdk(egxmzmxtgw) = 1% (no grade 4/5) nxdcbzawni (cyopvacsni ) View more	-	09 Dec 2024
NCT04245839 (TRANSCEND FL, ASH2024)	Phase 2	Refractory Follicular Lymphoma Third line CD19	101	Lisocabtagene Maraleucel (liso-cel)	italaaghgu(abkcatxxgq): RR = 1.25 (95% CI, 1.09 - 1.45) View more	Positive	08 Dec 2024
NCT04245839 (TRANSCEND FL, ASH2024)	Phase 2	Refractory Follicular Lymphoma Third line CD19	101	Axicabtagene Ciloleucel (axi-cel)		Positive	08 Dec 2024
ASH2024	Not Applicable	-	-	Lisocabtagene Maraleucel (liso-cel)	ckospksrje(tkmppiyeje) = kshtqhiphd ajxgiojufk (iggyejstvu, 45.1 - 58.5) View more	-	08 Dec 2024
ASH2024	Not Applicable	-	-	Lisocabtagene Maraleucel (liso-cel)	jfkodzrflv(drjbkgxnrw) = mostly low grade, was reported in 64% of pts elqkfuhcpl (wxrsjsvbvb ) View more	-	08 Dec 2024
ASH2024	Not Applicable	-	-	Lisocabtagene Maraleucel (liso-cel)	fkmenaorvv(xcuooqqnge) = any grade, 0.09 [0.04‒0.18]; grade ≥ 3, 0.09 [0.01‒0.75] whacjyffxg (jdrheigizt ) View more	-	08 Dec 2024
ASH2024	Not Applicable	-	-	Axicabtagene Ciloleucel (axi-cel)		-	08 Dec 2024
ASH2024	Not Applicable	-	-	Lisocabtagene Maraleucel (liso-cel)	eqjpjehfxs(yvehnqsjtf) = 45% (grade 1, 37 pts; grade 2, 17 pts; 1 pt each with grade 3, 4, and 5) umbpjgmeyl (ibqwhpevrh ) View more	-	08 Dec 2024
SOHO2024	Not Applicable	-	-	Lisocabtagene Maraleucel (liso-cel)	nnyyinmtwd(xfugfobcsq) = Eight (27%) patients died, including 7 because of disease progression bqrchgcmhk (taejyoubzr ) View more	-	04 Sep 2024
SOHO2024	Not Applicable	-	-	Liso-cel	(nqbyjucfoy) = jjsotzwiqj gubdqomydo (vnhwtxsard ) View more	-	04 Sep 2024

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