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.
NCT04257578 ↗	Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma	Recruiting	University of Washington	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
Refractory Diffuse Large B-Cell Lymphoma	4
Recurrent 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
Jazz Pharmaceuticals	1
Incyte Corporation	1

Sponsor Type

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

YESCARTA (axicabtagene ciloleucel): Clinical-Stage Update, Market Trajectory and Pricing-Profit Outlook

Last updated: May 3, 2026

What is YESCARTA and where is it used clinically?

YESCARTA is a CD19-directed, autologous CAR T-cell therapy (axicabtagene ciloleucel) developed for B-cell malignancies. Commercial use and label scope are driven by two late-stage indications that anchor uptake: relapsed or refractory large B-cell lymphoma and, in expanded label settings, earlier lines where trial data supports durability and survival benefit.

Core commercialization logic

• Autologous CAR T has a constrained manufacturing window and an established treatment pathway.
• Adoption is concentrated in large academic centers and high-volume cell-therapy programs with strong referral and capacity.

Regulatory and labeling anchor points (U.S.)

• FDA approval: 2017 for relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy (then-classic positioning for CAR T adoption). Source: FDA label history for YESCARTA (see citations).
• Subsequent expansions have increased eligible patient volume as payer coverage and clinical practice shift toward earlier lines in selected settings. Source: FDA prescribing information (see citations).

What do the most relevant clinical trials signal today?

Clinical-trials momentum for YESCARTA is best read through (1) durability, (2) earlier-line integration, and (3) comparisons against standard-of-care and competing CAR T platforms. The most decision-relevant trials for market projection are those that either (a) expand label or (b) defend use by improving outcomes or reducing failure-to-manufacture risk through protocol changes.

Clinical-trials evidence structure used for projection

• Efficacy endpoints: objective response rate (ORR), complete response (CR), duration of response (DOR), progression-free survival (PFS), overall survival (OS).
• Safety endpoints: grade 3/4 cytokine release syndrome (CRS) and neurologic events; rates of treatment discontinuation.
• Manufacturing reliability: bridging therapy rates, time-to-treatment, and failure-to-manufacture.

Implications for market timing

• If data supports earlier-line use, eligible volumes rise faster than linearly.
• If safety margins and manufacturing reliability improve, provider adoption deepens and outcomes become less center-dependent.

Trial program status that informs uptake

• YESCARTA development historically spans trials in diffuse large B-cell lymphoma and related aggressive B-cell lymphomas across relapsed/refractory and earlier lines, with readouts shaping guideline placement and reimbursement confidence. Source: clinical trial listings summarized by sponsor and major registries (see citations).

What is the market baseline for CAR T in large B-cell lymphoma?

CAR T in large B-cell lymphoma has moved from “late-line salvage” to “earlier-line consideration” depending on patient fitness, transplant eligibility, and local cell-therapy infrastructure. YESCARTA’s market position is anchored by:

• Established utilization pathways and payer familiarity
• Competition with other CD19 CAR T products and non-CAR T immunotherapies
• Ongoing trial readouts that can either expand or defend label territory

Demand drivers

• Incidence of large B-cell lymphoma in the U.S. and EU continues to support a steady pool of candidates.
• Treatment algorithms have shifted as CAR T becomes a standard option in selected relapsed/refractory settings.
• Earlier-line trials and real-world practice determine whether the addressable base grows faster than replacement by competing modalities.

Key constraints

• Slot capacity at manufacturing and treatment centers
• Patient referral funnel and bridging therapy planning
• Economics of manufacturing + administration under outcomes-based contracting

How does YESCARTA price and reimbursement work in practice?

Pricing for CAR T is typically structured as high list prices with discounts, outcome-based arrangements, and center contracting. For business projection, the model is treated as net revenue after:

• Manufacturer rebates/discounts
• Channel and payer-specific contracting
• Revenue timing based on authorization and dosing

Actionable revenue mechanics for forecasts

• ACAR T adoption is sensitive to reimbursement guardrails (step edits, prior authorization standards, and required documentation such as disease status and prior therapy lines).
• Net price varies by payer mix and outcomes-based agreements; market share shifts can move net revenue even if gross list price is stable.

Operational pricing risk

• If competitor products show better safety or durability, payers can steer usage through access criteria and outcomes thresholds.
• If new data triggers label changes, payer policy can lag, creating near-term friction then step-function adoption later.

What is the market projection logic for YESCARTA?

A credible projection for YESCARTA must map clinical-trial readouts into label coverage and then into payer adoption. The most finance-relevant linkages are:

1. Label expansion or guideline reinforcement

   • Increases addressable volume by broadening eligible lines or subtypes.
   • Raises steady-state utilization at high-volume centers.

2. Clinical durability and retreatment/next-therapy dynamics

   • Durable remissions reduce later lines of therapy utilization and influence payer willingness.
   • Longer DOR can stabilize share against competitors with shorter durability curves.

3. Safety and manufacturing reliability

   • Lower high-severity CRS and neurotoxicity rates can expand eligibility among frailer patients.
   • Improved manufacturability and shorter time-to-treatment increase successful dosing rates.

4. Competitive landscape

   • Uptake is share-weighted between CAR T products and other late-stage B-cell lymphoma therapies.
   • Share moves faster when outcomes are superior or when logistics are easier for providers.

Projected adoption curve (framework, not a single-point number)

• Phase 1 (baseline): stable uptake driven by established relapsed/refractory pathways.
• Phase 2 (growth): acceleration if trial results support earlier-line use and payer policy updates.
• Phase 3 (maturity): share stabilization as competing CAR T platforms reach scale and as newer non-CAR T options expand.

Where does competition pressure YESCARTA?

Competition in CD19 CAR T and in aggressive B-cell lymphoma includes:

• Other CAR T therapies targeting CD19 with different conditioning regimens and manufacturing workflows
• Bispecific antibodies and antibody-drug conjugates used in relapsed/refractory settings
• Standard-of-care regimens that regain share in subsets (for example, transplant-eligible patients or those with better performance status)

Competitive pressure points

• Efficacy: ORR and CR depth and durability are the primary drivers of durable share.
• Toxicity: rates of grade 3/4 CRS and neurologic events influence center protocols and patient selection.
• Logistics: time-to-treatment and bridging rates influence real-world success.

What are the key commercial KPIs to track for YESCARTA in 2026?

For business decisions, the KPIs that most directly map to revenue are:

• Patient conversion rate: referrals that become successfully dosed (manufacturing success).
• Time-to-dose: impacts bridging burden and scheduling capacity.
• CRS/neurotoxicity incidence: impacts hospitalization cost and throughput.
• Dose distribution: by line of therapy (where label expansions change mix).
• Payer authorization metrics: step-edit frequency and approval times.

Key takeaways for investors and R&D teams

• YESCARTA’s market trajectory depends on how trial data changes eligible line-of-therapy and patient selection, then how quickly payers incorporate it into access policy.
• Sustained share requires durable response evidence that holds against other CAR T products and non-CAR T options in relapsed/refractory diffuse large B-cell lymphoma.
• Clinical outcomes translate into economics through dosing success, inpatient burden from CRS management, and contracting structures tied to access and performance.

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Key Takeaways

1. YESCARTA is entrenched in relapsed/refractory large B-cell lymphoma and can grow if earlier-line trial data expands label and guideline use.
2. Market projection is driven more by eligible volume and payer access speed than by list price.
3. Manufacturing success and safety profile affect throughput and net economics in cell-therapy scale-up.
4. Competitive share will be determined by durability and toxicity management, plus logistics that determine real-world dosing rates.

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FAQs

1) What does YESCARTA target?

YESCARTA is a CD19-directed CAR T-cell therapy.

2) What clinical outcomes matter most for YESCARTA adoption?

ORR, CR durability (DOR/PFS), and the incidence of grade 3/4 CRS and neurologic events.

3) Why does manufacturing success drive revenue in CAR T?

Only successfully manufactured product can be dosed; failure-to-manufacture and delays reduce conversion from referral to treatment.

4) How does earlier-line use change market size?

Earlier-line indications expand the pool of eligible patients and increase utilization before patients reach later relapsed/refractory stages.

5) What is the main competitive risk to YESCARTA?

Competitors with superior durability, lower toxicity, or easier logistics can gain center and payer share, shifting net utilization.

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References

[1] U.S. Food and Drug Administration. Yescarta (axicabtagene ciloleucel) prescribing information. FDA.
[2] U.S. Food and Drug Administration. Yescarta approval and labeling history records. FDA.
[3] ClinicalTrials.gov. Search results and study listings for axicabtagene ciloleucel (Yescarta). U.S. National Library of Medicine.