CLINICAL TRIALS PROFILE FOR LISOCABTAGENE MARALEUCEL

All Clinical Trials for lisocabtagene maraleucel

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03575351 ↗	A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas	Active, not recruiting	Celgene	Phase 3	2018-10-23	The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a randomized, open-label, parallel-group, multi-center trial in adult subjects with Relapsed or refractory (R/R) aggressive Non-Hodgkin lymphoma (NHL) to compare safety and efficacy between the standard of care (SOC) strategy versus JCAR017 (also known as lisocabtagene maraleucel or liso-cel). Subjects will be randomized to either receive SOC (Arm A) or to receive JCAR017 (Arm B). All subjects randomized to Arm A will receive Standard of care (SOC) salvage therapy (R-DHAP, RICE or R-GDP) as per physician's choice before proceeding to High dose chemotherapy (HDCT) and Hematopoietic stem cell transplant (HSCT). Subjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an EFS event. Subjects randomized to Arm B will receive Lymphodepleting (LD) chemotherapy followed by JCAR017 infusion.
NCT04245839 ↗	A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)	Recruiting	Celgene	Phase 2	2020-07-14	This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL. The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This study is divided into three periods: - Pretreatment, which consists of screening assessments, leukapheresis and the Pretreatment evaluation; - Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and continues through JCAR017 administration at Day 1 with follow-up through Day 29; - Posttreatment, which includes follow-up assessments for disease status and safety for 2 years.
NCT05359211 ↗	NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma	Not yet recruiting	Nektar Therapeutics	Phase 1	2022-05-01	This phase Ib trial studies the effects of NKTR-255 in combination with chimeric antigen (CAR)-T cell therapy and to see how well they work in treating patients with large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). NKTR-255 is an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer. T cells are infection fighting blood cells that can kill tumor cells. Lisocabtagene maraleucel is a CAR-T cell product that consists of genetically engineered T cells, modified to recognize CD19, a protein on the surface of cancer cells. These CD19-specific T cells may help the body's immune system identify and kill CD19-positive cancer cells. Giving NKTR-255 together with lisocabtagene maraleucel may work better in treating large B-cell lymphoma than either drug alone.
NCT05359211 ↗	NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma	Not yet recruiting	Fred Hutchinson Cancer Center	Phase 1	2022-05-01	This phase Ib trial studies the effects of NKTR-255 in combination with chimeric antigen (CAR)-T cell therapy and to see how well they work in treating patients with large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). NKTR-255 is an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer. T cells are infection fighting blood cells that can kill tumor cells. Lisocabtagene maraleucel is a CAR-T cell product that consists of genetically engineered T cells, modified to recognize CD19, a protein on the surface of cancer cells. These CD19-specific T cells may help the body's immune system identify and kill CD19-positive cancer cells. Giving NKTR-255 together with lisocabtagene maraleucel may work better in treating large B-cell lymphoma than either drug alone.
NCT05583149 ↗	Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas	Not yet recruiting	AstraZeneca	Phase 2	2022-10-01	This research is being done to assess the effectiveness and safety of acalabrutinib combined with lisocabtagene maraleucel (liso-cel) for people with relapsed/refractory aggressive B-cell lymphoma. This research study involves the study drug acalabrutinib in combination with lisocabtagene maraleuce

Clinical Trial Conditions for lisocabtagene maraleucel

Condition Name

Condition Name for lisocabtagene maraleucel
Intervention	Trials
Recurrent Transformed Chronic Lymphocytic Leukemia	2
Refractory Transformed Chronic Lymphocytic Leukemia	2
Grade 3b Follicular Lymphoma	2
Refractory Diffuse Large B-Cell Lymphoma	2

Condition MeSH

Condition MeSH for lisocabtagene maraleucel
Intervention	Trials
Lymphoma	8
Lymphoma, B-Cell	7
Lymphoma, Non-Hodgkin	6
Lymphoma, Large B-Cell, Diffuse	5

Clinical Trial Locations for lisocabtagene maraleucel

Trials by Country

Trials by Country for lisocabtagene maraleucel
Location	Trials
United States	68
France	9
Germany	9
Spain	7
Canada	5

Trials by US State

Trials by US State for lisocabtagene maraleucel
Location	Trials
Washington	5
Texas	5
Massachusetts	5
California	5
New York	4

Clinical Trial Progress for lisocabtagene maraleucel

Clinical Trial Phase

Clinical Trial Phase for lisocabtagene maraleucel
Clinical Trial Phase	Trials
PHASE3	2
PHASE2	3
PHASE1	1

Clinical Trial Status

Clinical Trial Status for lisocabtagene maraleucel
Clinical Trial Phase	Trials
NOT_YET_RECRUITING	5
Not yet recruiting	5
Recruiting	2

Clinical Trial Sponsors for lisocabtagene maraleucel

Sponsor Name

Sponsor Name for lisocabtagene maraleucel
Sponsor	Trials
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company	3
National Cancer Institute (NCI)	2
Merck Sharp & Dohme LLC	2

Sponsor Type

Sponsor Type for lisocabtagene maraleucel
Sponsor	Trials
Industry	12
Other	9
NIH	2

Lisocabtagene Maraleucel (liso-cel): Clinical Trials, Market Analysis, and Projections

Last updated: February 22, 2026

What is lisocabtagene maraleucel?

Lisocabtagene maraleucel (liso-cel) is a chimeric antigen receptor T-cell (CAR-T) therapy developed by Bristol-Myers Squibb. It targets CD19-positive B-cell malignancies, primarily diffuse large B-cell lymphoma (DLBCL). The therapy involves collecting patient T-cells, genetically modifying them to attack cancer cells, then reinfusing them.

What is the current status of clinical trials?

Ongoing and Completed Trials

Trial Phase	Number of Trials	Focus	Status	Key Outcomes/Progress
Phase 1 / 2	6	Safety, dose escalation, efficacy in B-cell lymphoma	Ongoing	Preliminary data indicates response rates of approximately 80%.
Phase 3	1 (Transplant-eligible DLBCL)	Efficacy compared to standard therapies	Recruiting	Expected completion in Q4 2024.
Registrational	2	Confirmatory trials for DLBCL and primary mediastinal B-cell lymphoma (PMBCL)	Initiated	Pending initial data release.

Recent Clinical Data

• A Phase 2 study (TRANSCEND NHL 001) enrolled 268 patients with relapsed/refractory large B-cell lymphoma, reporting overall response rates (ORR) of 73%, with complete responses (CR) at 53%.
• Median duration of response (DOR) exceeded 11 months.
• Grade 3 or higher cytokine release syndrome (CRS) occurred in 4% of cases, neurotoxicity in 9%, indicating a manageable safety profile.

Regulatory Status

• Approved in U.S. (FDA: August 2021) for adult patients with relapsed/refractory large B-cell lymphoma after two or more lines of systemic therapy.
• Approved in EU (EMA: August 2022) under similar indications.
• Submission ongoing in Japan and other markets, with regulatory decisions anticipated through 2023-2024.

Market Analysis

Market size

Indicator	Value	Source
U.S. population with R/R DLBCL	10,000 – 15,000 cases/year	[1]
Market for CAR-T therapies in hematologic cancers	$7.7 billion (2022)	[2]
Expected CAGR (2023-2030)	15%	[3]

Competitive landscape

Product	Developer	Approval	Indications	Response Rates	Key Differences
Axicabtagene ciloleucel (Yescarta)	Gilead	Yes	R/R DLBCL	ORR: 80%, CR: 54%	Established, first-mover in CAR-T
Lisocabtagene maraleucel (Breyanzi)	Bristol-Myers Squibb	Yes	R/R LBCL, PMBCL	ORR: 73%, CR: 53%	Improved safety profile, standardized dosing
Tisagenlecleucel (Kymriah)	Novartis	Yes	R/R ALL, DLBCL	ORR: 52-75%	Approved for pediatric and adult indications

Revenue projections (2023-2030)

Year	Estimated sales	Assumptions	Source
2023	$300 million	Launch uptake, initial approvals	[4]
2025	$1 billion	Expanded indications, global approval	Industry estimates
2030	$3-4 billion	Market penetration, repeat treatments	Company projections

Drivers & Challenges

Drivers:

• Growing approval of CAR-T therapies for hematologic cancers.
• High response rates and durable remissions in relapsed/refractory populations.
• Expanding indications beyond DLBCL.

Challenges:

• Manufacturing complexity and costs.
• Safety concerns such as CRS and neurotoxicity.
• Competition from established CAR-T products and emerging therapies.

Future outlook

• Pending results from ongoing Phase 3 trials will determine lisocabtagene maraleucel’s broader approval scope.
• The therapy’s positioning depends on safety profile, cost-effectiveness, and compatibility with combination regimens.
• Market share forecast hinges on regulatory approvals in Asia, especially Japan, and reimbursement pathways.

Key Takeaways

• Lisocabtagene maraleucel is approved for R/R large B-cell lymphoma with promising clinical data.
• Current trials aim to establish efficacy in earlier lines and other B-cell malignancies.
• The global CAR-T therapy market is expanding rapidly, with projections reaching $3-4 billion by 2030.
• Competition remains intense among first- and second-generation CAR-T therapies.
• Manufacturing, safety, and cost remain critical factors shaping market access.

FAQs

1. What are the main differences between lisocabtagene maraleucel and other CAR-T therapies?
Liso-cel features a defined composition of CD4+ and CD8+ T cells, aiming for a more consistent product. It has a favorable safety profile, with lower incidences of severe CRS and neurotoxicity compared to some competitors.

2. How does the safety of liso-cel compare in clinical trials?
Clinical data shows a lower incidence of severe adverse events. Grade 3 or higher CRS occurs in approximately 4% of patients, neurotoxicity in 9%, versus higher rates in earlier-generation CAR-T therapies.

3. When will lisocabtagene maraleucel gain approvals for additional indications?
Pending trial results, regulatory filings for earlier lines of therapy and other B-cell malignancies are expected in 2024-2025.

4. What are the primary competitors for lisocabtagene maraleucel?
Primarily, Yescarta and Kymriah. These have extensive market presence and approval for a broad range of indications. Next-generation therapies and pipeline products also pose future competition.

5. What are the key barriers to market growth?
Manufacturing complexity, treatment costs, safety management, and reimbursement policies are significant barriers. The high cost of therapy (~$375,000 to $475,000 per treatment) influences adoption.

---

References

1. National Cancer Institute. (2022). B-cell Non-Hodgkin Lymphoma Treatment (Adult).
2. Clarivate. (2022). Oncology Pipeline & Market Analytics.
3. Grand View Research. (2023). CAR-T Cell Therapy Market Size, Share & Trends.
4. Bristol-Myers Squibb. (2023). Breyanzi (lisocabtagene maraleucel) Prescribing Information.