CLINICAL TRIALS PROFILE FOR YESCARTA

All Clinical Trials for YESCARTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03642626 ↗	MT2017-45: CAR-T Cell Therapy for Heme Malignancies	Recruiting	Masonic Cancer Center, University of Minnesota		2018-12-18	This is a phase II study of FDA-approved CAR-T products for patients with hematologic malignancies. Patients will be assigned to Arm A and B based on age and diagnosis. Overall remission rate, safety events and other endpoints will be calculated for Arm A and B separately.
NCT03954106 ↗	A Safety and Efficacy Study of Defibrotide in the Prevention of Chimeric Antigen Receptor-T-cell-associated Neurotoxicity	Terminated	Jazz Pharmaceuticals	Phase 2	2019-10-04	This is a prospective, open-label, single-arm study evaluating the safety and efficacy of defibrotide for the prevention of CAR-T-associated neurotoxicity in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) receiving Yescarta.
NCT04205838 ↗	Anakinra in Preventing Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome in Patients With Recurrent or Refractory Large B-cell Lymphoma	Suspended	National Cancer Institute (NCI)	Phase 2	2020-03-04	This phase II trial studies how well anakinra works in preventing severe chimeric antigen receptor T-cell-related encephalopathy syndrome after chimeric antigen receptor T-cell therapy in patients with large B-cell lymphoma that has come back or has not responded to treatment. Immunosuppressive therapy, such as anakinra, is used to decrease the body?s immune response, which may prevent severe chimeric antigen receptor T-cell-related encephalopathy syndrome.
NCT04205838 ↗	Anakinra in Preventing Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome in Patients With Recurrent or Refractory Large B-cell Lymphoma	Suspended	Jonsson Comprehensive Cancer Center	Phase 2	2020-03-04	This phase II trial studies how well anakinra works in preventing severe chimeric antigen receptor T-cell-related encephalopathy syndrome after chimeric antigen receptor T-cell therapy in patients with large B-cell lymphoma that has come back or has not responded to treatment. Immunosuppressive therapy, such as anakinra, is used to decrease the body?s immune response, which may prevent severe chimeric antigen receptor T-cell-related encephalopathy syndrome.
NCT04257578 ↗	Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma	Recruiting	AstraZeneca	Phase 1/Phase 2	2020-12-02	This phase I/II trial studies the safety of acalabrutinib and axicabtagene ciloleucel in treating patients with B-cell lymphoma. Acalabrutinib may stop the growth of tumor cells by blocking key pathways needed for cell growth. Immunotherapy with axicabtagene ciloleucel is engineered to target a specific surface antigen on lymphoma cells. Acalabrutinib may enhance the efficacy of axicabtagene ciloleucel in treating patients with B-cell lymphoma.
NCT04257578 ↗	Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma	Recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2020-12-02	This phase I/II trial studies the safety of acalabrutinib and axicabtagene ciloleucel in treating patients with B-cell lymphoma. Acalabrutinib may stop the growth of tumor cells by blocking key pathways needed for cell growth. Immunotherapy with axicabtagene ciloleucel is engineered to target a specific surface antigen on lymphoma cells. Acalabrutinib may enhance the efficacy of axicabtagene ciloleucel in treating patients with B-cell lymphoma.

Clinical Trial Conditions for YESCARTA

Condition Name

Condition Name for YESCARTA
Intervention	Trials
Recurrent Diffuse Large B-Cell Lymphoma	4
Refractory Diffuse Large B-Cell Lymphoma	4
Refractory High Grade B-Cell Lymphoma	3
Recurrent High Grade B-Cell Lymphoma	3

Condition MeSH

Condition MeSH for YESCARTA
Intervention	Trials
Lymphoma	8
Lymphoma, Large B-Cell, Diffuse	7
Lymphoma, B-Cell	7
Lymphoma, Follicular	5

Clinical Trial Locations for YESCARTA

Trials by Country

Trials by Country for YESCARTA
Location	Trials
United States	13
Canada	1

Trials by US State

Trials by US State for YESCARTA
Location	Trials
Massachusetts	2
Missouri	1
Oregon	1
Florida	1
New York	1

Clinical Trial Progress for YESCARTA

Clinical Trial Phase

Clinical Trial Phase for YESCARTA
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 2	5

Clinical Trial Status

Clinical Trial Status for YESCARTA
Clinical Trial Phase	Trials
Recruiting	6
Not yet recruiting	3
NOT_YET_RECRUITING	2

Clinical Trial Sponsors for YESCARTA

Sponsor Name

Sponsor Name for YESCARTA
Sponsor	Trials
National Cancer Institute (NCI)	5
Southwest Oncology Group	1
Jazz Pharmaceuticals	1

Sponsor Type

Sponsor Type for YESCARTA
Sponsor	Trials
Other	14
Industry	5
NIH	5

Comprehensive Review: Clinical Trials, Market Analysis, and Future Projections for YESCARTA (Axicabtagene Ciloleucel)

Last updated: February 1, 2026

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Summary

YESCARTA (axicabtagene ciloleucel), developed by Gilead Sciences through its Kite Pharma division, is a CAR T-cell therapy approved for specific hematologic malignancies, primarily refractory large B-cell lymphoma (LBCL). This report delineates current clinical trial landscapes, evaluates market dynamics, and offers projections for future growth and use. It emphasizes regulatory milestones, competitive positioning, and potential market expansion opportunities through 2030.

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1. Clinical Trials Update for YESCARTA

1.1 Approved Indications and Ongoing Trials

Indications	Regulatory Status	Key Trials (Ongoing/Completed)	Trial Focus
Refractory large B-cell lymphoma	FDA approved (October 2017); EMA (2018)	ZUMA-1 (Completed), ZUMA-7 (Ongoing), ZUMA-12 (Ongoing), ZUMA-5 (Ongoing)	Efficacy, safety, real-world application, early line treatment
Primary mediastinal B-cell lymphoma	Approved in US and EU	ZUMA-1, ZUMA-7	Long-term durability, rapid response, safety profile
Transformed follicular lymphoma	Ongoing (ZUMA-5)	Evaluating response in different subtypes	Efficacy in transformed settings

1.2 Clinical Trial Milestones & Data Highlights

Year	Trial Name	Phase	Participants	Key Results
2017	ZUMA-1	Phase 2	101	ORR: 83%, CR: 58%, Median duration of response (DOR): 11.1 months
2021	ZUMA-7	Phase 3	366	Demonstrated superior complete response rate vs standard of care (45% vs 17%) (p<0.001)
2020	ZUMA-12	Phase 2	138	Evaluated efficacy in earlier-line setting; ORR: 83%, CR: 66%
2022	ZUMA-22 (Registrational)	Ongoing	N/A	Focusing on pivotal data for broader indications and potential label expansion

1.3 Safety & Management

• Cytokine Release Syndrome (CRS): observed in 93% of cases, with Grade ≥3 in 11% (ZUMA-1)
• Neurotoxicity: in 64%; Grade ≥3 in 21%
• Management protocols emphasize early intervention with tocilizumab, corticosteroids

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2. Market Analysis and Competitive Landscape

2.1 Current Market Size & Revenue

Region	2022 Market Size (USD million)	Key Competitors	Market Share (Estimated)
United States	\$1,200	YESCARTA, TECARTUS, KTE-X19	YESCARTA (45%), TECARTUS (35%)
European Union	\$750	YESCARTA, Tecartus	YESCARTA (50%), Tecartus (30%)
Rest of World	\$450	Limited deployment	Mainly in US/EU markets

Note: The CAR T-cell therapy market generated an estimated \$2.4 billion in 2022, projected to grow at a CAGR of 20% through 2030.

2.2 Competitive Products & Differentiation

Product	Developer	Indications	Approval Date	Key Differentiators
YESCARTA	Gilead/Kite	LBCL, primary mediastinal	2017 (FDA)	First FDA-approved CAR T for large B-cell lymphoma
TECARTUS (Breyanzi)	Celgene/Bristol-Myers Squibb	LBCL, MCL	2021 (FDA)	Approved for mantle cell lymphoma, differentiated by manufacturing process
KTE-X19	Gilead/Kite	Mantle cell lymphoma	Phase 2 only	Demonstrated high response rates in trials

2.3 Regulatory & Reimbursement Landscape

Region	Regulatory Status	Reimbursement Challenges	Policy Highlights
U.S.	FDA-approved for multiple indications; CMS SIM procedures support reimbursement for CAR T therapies	High initial costs; Value-based models emerging	Cost approximately \$373,000 per treatment, with new payment models under development
EU	EMA approved; national health authorities determine reimbursement levels	Varies by country; approval flux	Reimbursement often slower, impede access in some countries
Asia-Pacific	Limited approvals; clinical trials ongoing in China, Japan, South Korea	Regulatory variances; pricing	Growth anticipated as approvals expand, driven by unmet needs

2.4 Market Expansion & Future Opportunities

• Indications Expansion: Ongoing research into earlier-line therapy, combination regimens, and solid tumors.
• Geographical Penetration: Growing presence in Asian markets and Latin America.
• Line of Therapy: Moving from refractory to first-line treatment in certain indications based on trial results.

Potential Market Opportunities (USD million)	Predicted Timeline	Key Drivers
First-line LBCL (early-line use)	2025-2030	Positive trial outcomes, regulatory approvals, payer acceptance
Pediatric B-cell lymphoma	2025-2028	Ongoing trials, unmet needs
Expanded indications (e.g., multiple myeloma)	2027-2030	Research progression

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3. Future Market Outlook and Projections

3.1 Market Growth Projections (2023–2030)

Year	Estimated Global Market (USD million)	CAGR	Comments
2023	\$2.8 billion	—	Current market size
2025	\$4.8 billion	20%	Expansion into earlier-line therapy
2030	\$10 billion	20%	Expected broad indication approval, increased access

3.2 Key Factors Influencing Growth

• Regulatory Approvals: Expanded indications and line-of-therapy approvals.
• Manufacturing Capacity: Increased production facilities and technological advances.
• Price and Reimbursement: Adoption of value-based reimbursement models.
• Competition: Entry of novel CAR T therapies, biosimilars, and allogeneic options.
• COVID-19 Impact: Continued effects on clinical trial operations and supply chain.

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4. Comparative Analysis with Peer Therapies

Parameter	YESCARTA	TECARTUS	KTE-X19	Emerging Therapies
Approval Year	2017	2021	Phase 2	NA
Indications	LBCL, PMBCL	LBCL, MCL	MCL	Solid tumors, other hematologic
Response Rate	ORR: 83%, CR: 58% (ZUMA-1)	High in MCL	Promising in early trials	Varies
Toxicity Profile	CRS (93%), Neurotoxicity	Similar	Similar	Varies
Manufacturing	Autologous	Autologous	Autologous	Allogeneic (off-the-shelf)

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5. FAQs

Q1: How does YESCARTA compare to other CAR T therapies in efficacy?
A: Clinical data indicates that YESCARTA offers high response rates (ORR around 83%; CR approximately 58%) comparable or superior to competitors in refractory LBCL, with long-term durability shown in extended follow-ups.

Q2: What are the main safety concerns associated with YESCARTA?
A: CRS and neurotoxicity are primary adverse events. Management protocols involving tocilizumab and corticosteroids effectively mitigate severity, but close monitoring remains essential.

Q3: Are there ongoing efforts to expand YESCARTA’s indications?
A: Yes. Trials are evaluating its use in earlier lines of therapy, primary mediastinal lymphoma, and potentially in solid tumors, aiming to broaden market access.

Q4: How does manufacturing complexity affect market supply?
A: Autologous cell therapy manufacturing involves complex logistics, contributing to high costs and capacity constraints. Advances in automation and off-the-shelf allogeneic versions seek to address these challenges.

Q5: What is the outlook for YESCARTA’s market share by 2030?
A: With expanding indications and increasing acceptance, YESCARTA could maintain around 40-50% of the CAR T-market, potentially increasing if competitors face delays or set-backs.

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Key Takeaways

• Regulatory Milestones: YESCARTA remains a pioneer, with approved indications expanding and ongoing pivotal trials supporting future label expansions.
• Market Potential: The global CAR T-cell therapy market is projected to reach \$10 billion by 2030, with YESCARTA at the forefront.
• Competitive Dynamics: While YESCARTA maintains a leading position, emerging therapies and biosimilars pose competitive pressure.
• Operational Challenges: Manufacturing complexities and reimbursement policies significantly influence market reach.
• Growth Drivers: Advancements in trial data, indication expansion, and regional penetration will sustain growth momentum.

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References

[1] Gilead Sciences. (2022). YESCARTA (axicabtagene ciloleucel) Prescribing Information.
[2] US Food and Drug Administration. (2017). FDA approves first CAR T-cell therapy for certain types of large B-cell lymphoma.
[3] MarketWatch. (2022). Global CAR T-cell Therapy Market report.
[4] ClinicalTrials.gov. (accessed 2023). List of clinical trials involving YESCARTA.
[5] IQVIA. (2022). The evolving landscape of gene therapies.