CAR T-Cell Therapy in 2026 and Beyond: Evolving Evidence, Expanding Indications, and the Path to Broader Access

Introduction

Chimeric antigen receptor (CAR) T-cell therapy has emerged as one of the most transformative advances in modern oncology, redefining treatment paradigms for select hematologic malignancies.¹ By harnessing a patient’s own immune system through ex vivo genetic modification, CAR T-cell therapies enable targeted recognition and elimination of malignant cells, offering the potential for deep and durable remissions in populations with historically limited therapeutic options.^1,2 While CAR T-cell therapy is typically administered as a single, onetime infusion after a patient’s own T cells are genetically modified, it differs from other novel therapies such as bispecific antibodies, which are given as repeated, ongoing doses (weekly or biweekly) to continuously bridge existing T cells to cancer cells.² CAR T-cell therapy is a living therapy that represents a paradigm shift from conventional cytotoxic and targeted approaches, introducing both unprecedented clinical promise and substantial complexity in care delivery.

Since the initial regulatory approvals of CAR T-cell therapies in relapsed or refractory B-cell malignancies, the field has evolved rapidly.^1,3 Early milestones included approvals for pediatric and young adult acute lymphoblastic leukemia and diffuse large B-cell lymphoma in 2017, followed by expanded indications across additional lymphoma subtypes, and subsequent approvals for multiple myeloma in 2021 and 2022.^1,3 More recently, CAR T-cell therapy is expanding beyond oncology into areas such as autoimmune, infectious, and fibrotic diseases, with early successes including HIV treatment and promising outcomes in conditions such as systemic lupus erythematosus and antisynthetase syndrome.⁴ Parallel advances in chimeric antigen receptor construct design, manufacturing efficiency, and toxicity management have contributed to improved safety profiles and broader applicability.^1,5,6 At the same time, real-world evidence has begun to validate, and in some cases challenge, clinical trial findings, particularly in more heterogeneous patient populations; 1 real-world outcomes study demonstrated lower overall response rates in relapsed/refractory large B-cell lymphoma among non-Hispanic Black patients treated with axicabtagene ciloleucel (Yescarta; Kite Pharma) compared with clinical trial efficacy. ⁷ As clinical experience has grown, so, too, has interest in expanding access to CAR T-cell therapy beyond academic medical centers into community oncology settings.

Historically, CAR T-cell delivery has been concentrated in specialized centers due to the need for multidisciplinary expertise, complex logistics, and infrastructure to manage potentially severe toxicities such as cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS).⁸ However, evolving care models, improved toxicity mitigation strategies, and increasing demand from patients and providers have prompted a re-examination of where and how CAR T-cell therapy can be safely and effectively delivered.⁸

Despite these advances, significant barriers to access remain. These include challenges related to referral pathways, manufacturing timelines, reimbursement complexity, site-of-care restrictions, and disparities in geographic availability.⁸ Community oncology networks, which provide the majority of cancer care in the US, are increasingly exploring pathways to participate in CAR T-cell delivery.⁹ Understanding the operational realities of integrating CAR T-cell therapy into these settings is critical to ensuring equitable access while maintaining high standards of care.

The purpose of this article is to bridge the gap between the rapidly evolving clinical landscape of CAR T-cell therapy and the practical considerations required for broader implementation. This review examines clinical progress in CAR T-cell therapy and provides a comprehensive framework for stakeholders seeking to expand access to care, particularly in community oncology settings.

Evolution of CAR T-Cell Therapy

Initial approvals of autologous CAR T-cell therapies targeting CD19 established proof of concept for adoptive cellular immunotherapy, demonstrating high response rates and the potential for durable remissions in heavily pretreated populations.³ The first CAR T-cell therapy approved by the FDA was tisagenlecleucel (Kymriah; Novartis) in August 2017 for pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).⁴ This was followed by its later approval for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after 2 or more lines of systemic therapy.¹⁰ In October 2017, axicabtagene ciloleucel was approved for adult patients with relapsed or refractory large B-cell lymphoma, including DLBCL, primary large mediastinal B-cell lymphoma, high-grade B-cell lymphoma, and transformed follicular lymphoma, also after 2 or more prior lines of therapy. ^4,11

Subsequent approvals expanded both the range of eligible malignancies and available CAR T-cell products. Brexucabtagene autoleucel (Tecartus; Kite Pharma) received FDA approval in July 2020 for relapsed or refractory mantle cell lymphoma, and in October 2021, for adult patients with relapsed or refractory B-cell precursor ALL.^4,12,13 Lisocabtagene maraleucel (Breyanzi; Bristol Myers Squibb) was approved in February 2021 for relapsed or refractory large B-cell lymphoma after 2 or more prior lines of therapy and has since gained expanded indications, including second-line use in certain patients with high-risk disease.^4,14

The therapeutic landscape further broadened with the introduction of B-cell maturation antigen (BCMA)–targeted CAR T-cell therapies for multiple myeloma.^15,16 Idecabtagene vicleucel (Abecma; Bristol Myers Squibb) was approved in March 2021 for adult patients with relapsed or refractory multiple myeloma after 4 or more prior lines of therapy, followed by ciltacabtagene autoleucel (Carvykti; Janssen Biotech) in February 2022 for a similar population.^4,15-18 Both therapies have since moved into earlier lines of treatment, with label expansions reflecting strong efficacy in less heavily pretreated patients.^15,16

These approvals have been accompanied by key therapeutic breakthroughs that have improved both efficacy and safety. Early clinical experience highlighted significant risks associated with CRS and ICANS.² Over time, the development of standardized grading systems and earlier, protocol-driven intervention has substantially improved toxicity management.² Treatment guidelines for CRS and ICANS focus on rapid grading, supportive care, and early intervention with tocilizumab, an interleukin-6 antagonist, for CRS, and corticosteroids for ICANS; patients treated in an outpatient setting are advised to remain within 2 hours of the treatment center for 4 to 8 weeks following CAR T-cell administration to ensure prompt toxicity management.¹⁹ These advances have enabled more manageable safety profiles and reduced reliance on intensive care-level support.

In parallel, substantial progress has been made in the operational aspects of CAR T-cell delivery. Refinements in apheresis techniques, improvements in manufacturing consistency, and reductions in vein-to-vein time have enhanced feasibility.⁶ Innovations, including automated manufacturing platforms, cryopreservation, and exploration of allogeneic (“off-the-shelf”) CAR T-cell constructs, are further positioning the field for scalability.⁶

One of the most notable shifts in recent years has been the movement toward outpatient administration of CAR T-cell therapy. Initially limited to inpatient settings due to safety concerns, CAR T-cell therapy is increasingly being delivered in outpatient or hybrid models for appropriately selected patients.²⁰ This transition has been enabled by improved toxicity mitigation strategies, enhanced monitoring protocols, and accumulated institutional experience.²⁰ Outpatient administration carries important implications for patient access, health care resource utilization, and total cost of care, and represents a critical step toward broader adoption in community oncology settings.^9,20

Regulatory evolution has also facilitated expanded access. Early CAR T-cell therapy approvals were accompanied by stringent Risk Evaluation and Mitigation Strategy (REMS) requirements.²¹ However, in June 2025, the FDA removed REMS requirements for all approved CD19- and BCMA-directed CAR T-cell therapies, citing sufficient safety guidance within existing labeling and reflecting increased confidence in toxicity management and real-world safety outcomes.²¹ This change eliminates site certification and tocilizumab stocking requirements, reduces postinfusion monitoring proximity from 4 weeks to 2, and allows greater flexibility in monitoring and driving restrictions.²¹

Collectively, these clinical, operational, and regulatory advances have transformed CAR T-cell therapy from a highly specialized, resource-intensive intervention into a more scalable treatment modality. This evolution provides a foundation for expanding access beyond academic medical centers to community-based centers seeking to offer CAR T-cell therapy, while maintaining safety standards.

Current FDA-Approved CAR T-Cell Products and Clinical Positioning

B-Cell Malignancies

CAR T-cell therapies targeting CD19 have become a cornerstone in the management of relapsed or refractory B-cell malignancies. Multiple products are now approved across ALL and various non-Hodgkin lymphoma (NHL) subtypes.³

In pediatric and young adult ALL, tisagenlecleucel remains the primary CAR T-cell therapy option. The pivotal phase 2 ELIANA trial (NCT02435849) demonstrated a high overall remission rate (81%) and durable responses (6-month relapse-free survival rate, 80% in responders) in a heavily pretreated population.²² Grade 3 or 4 adverse events occurred in 88% of patients, with CRS of any grade occurring in 77%.²² Brexucabtagene autoleucel expanded the CAR T-cell landscape in the adult ALL setting based on results from the phase 2 ZUMA-3 trial (NCT02614066), with 71% achieving complete remission or complete remission with incomplete hematological recovery in adults with relapsed or refractory disease.²³ The most common grade 3+ adverse events were anemia (49%) and pyrexia (36%).²³

In aggressive B-cell lymphomas, including DLBCL and primary mediastinal B-cell lymphoma (PMBCL), 3 CD19-directed CAR T-cell products are utilized: axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel.³ The ZUMA-1 trial (NCT02348216) demonstrated high response rates of axicabtagene ciloleucel in DLBCL/PMBCL, with an objective response rate of 82% and a complete response (CR) of 52%.²⁴ Tisagenlecleucel was evaluated in the JULIET trial (NCT02445248) for refractory DLBCL, achieving an objective response rate of 52%, with 40% CR and 12% partial response. ²⁵ In the TRANSCEND NHL 001 trial (NCT02631044), lisocabtagene maraleucel achieved high efficacy in relapsed/refractory LBCL with a 73% objective response rate, including 53% CR.²⁵

More recently, randomized phase 3 trials have reshaped the treatment paradigm by evaluating CAR T-cell therapy in the second-line setting for patients with early relapse or primary refractory disease.²⁶ Axicabtagene ciloleucel and lisocabtagene maraleucel have been compared with standard salvage chemotherapy followed by autologous stem cell transplantation, leading to their approvals as a second-line option in eligible patients.²⁶ At a median follow-up of 24.9 months, axicabtagene ciloleucel demonstrated event-free survival (EFS) of 8.3 months vs 2.0 months in the standard-of-care group.²⁷ In a similar setting, median EFS was not reached for lisocabtagene maraleucel vs 2.4 months for standard of care at a median 17.5-month follow-up.²⁸

In indolent lymphomas, CAR T-cell therapy has also demonstrated strong efficacy. Axicabtagene ciloleucel received approval for relapsed or refractory follicular lymphoma based on the ZUMA-5 trial (NCT03105336), while tisagenlecleucel was approved for the same indication based on the ELARA study (NCT03568461).²⁹ Both trials reported high CR rates (79% and 69.1%, respectively) and durable remissions, positioning CAR T-cell therapy as a valuable option after multiple prior lines of therapy.²⁹

In mantle cell lymphoma, brexucabtagene autoleucel demonstrated efficacy in the ZUMA-2 trial (NCT02601313), with high response rates (overall response rate, 85%; CR, 59%) in a population that failed to respond to or progressed on Bruton tyrosine kinase inhibitors.²⁹

Across B-cell malignancies, CAR T-Cell therapies are increasingly being integrated earlier in treatment algorithms, particularly in high-risk or refractory disease. However, optimal sequencing relative to other emerging therapies remains an area of active investigation and has important implications for real-world clinical decision-making.

Multiple Myeloma

The introduction of BCMA-targeted CAR T-cell therapies has significantly altered the treatment landscape for relapsed or refractory multiple myeloma (RRMM), a disease characterized by repeated relapses and eventual treatment resistance.

Two CAR T-cell products are currently approved in the RRMM setting: idecabtagene vicleucel and ciltacabtagene autoleucel.³⁰ Idecabtagene vicleucel was evaluated in the KarMMa phase 2 study (NCT03361748), which demonstrated a meaningful overall response rate of 81% in patients receiving the highest target CAR T-cell dose, with 59% achieving a minimal residual disease–negative status after 12 months.³⁰ Patients were heavily pretreated and received at least 3 prior lines of therapy.³⁰ CRS was common, occurring in 84% of patients.³⁰ Ciltacabtagene autoleucel, studied in the CARTITUDE-1 phase 1b trial (NCT03548207), showed particularly high response rates (overall response rate, 98%), with 80% achieving stringent CR in RRMM patients.³⁰ CRS was reported in 95% of patients.³⁰

Subsequent phase 3 trials have supported the movement of CAR T-cell therapy into earlier lines of treatment. The KarMMa-3 trial (NCT03651128) demonstrated improved progression-free survival with idecabtagene vicleucel compared with standard regimens in patients with 2 to 4 prior lines of therapy (13.8 months vs 4.4 months).³⁰ Similarly, the CARTITUDE-4 study (NCT04181827) showed improved outcomes for ciltacabtagene autoleucel in earlier lines of treatment (1-3 prior lines), with patients achieving an overall response rate of 85% vs 67% for standard therapies.³⁰ These findings have led to label expansions and are reshaping treatment sequencing in clinical practice.³⁰

Vision for an Expanded Community-Based CAR T-Cell Therapy Ecosystem

Historically, site accreditation through Foundation for the Accreditation of Cellular Therapy (FACT) has served as an important benchmark for quality, ensuring that centers meet rigorous standards for cellular therapy collection, processing, and administration.³¹ As CAR T-cell therapy continues to mature clinically, attention has increasingly shifted toward expanding access beyond academic medical centers and into community oncology settings. Some community oncology programs have successfully implemented components of CAR T-cell care in collaboration with accredited treatment centers or partner hospitals, without independently maintaining full FACT accreditation. The Association of Cancer Care Centers (ACCC) and other stakeholders have articulated a vision for a more distributed, patient-centered CAR T-cell therapy ecosystem.⁸

A foundational element of this model is early and accurate patient identification, which remains a persistent gap in community oncology. ACCC emphasizes the importance of structured referral pathways supported by multidisciplinary committees that evaluate patients using a 3-pronged framework encompassing clinical eligibility, financial feasibility including preauthorization, and logistical readiness to assess potential barriers to care.⁸ This approach ensures that patients are identified within the optimal treatment window and reduces delays associated with fragmented evaluation processes.

Equally critical is robust care coordination between referring providers and certified treatment centers. CAR T-cell therapy involves multiple transitions, including referral, leukapheresis, bridging therapy, lymphodepletion, infusion, and posttreatment monitoring, each of which requires clear delineation of roles and continuous communication.⁸ ACCC underscores that referring oncologists should remain actively engaged throughout the patient journey, co-managing care alongside treating centers.⁸

Operationalizing CAR T-cell therapy in community settings also depends on infrastructure readiness and workforce development. Case studies highlighted by ACCC show that outpatient programs can be successfully implemented with appropriate staffing, comprehensive education and training, intensive monitoring protocols, and established processes for patient triage.⁸ These models not only enhance patient convenience and satisfaction but also may improve reimbursement dynamics and optimize health care accessibility.⁸

Finally, financial navigation and reimbursement alignment remain central to ecosystem expansion. Estimates of the costs of care per patient associated with CAR T-cell therapy can exceed $1 million.⁸ The complexity of prior authorization, variability in payer policies, and high total cost of care are significant barriers to treatment.⁸ Programs that proactively engage payers and streamline authorization processes are better positioned to avoid treatment delays and expand access.

Taken together, the ACCC framework reinforces that the future CAR T-cell therapy ecosystem will depend on tightly coordinated, multidisciplinary, and networked care models. By aligning clinical workflows, operational infrastructure, and reimbursement strategies, community oncology practices can play an increasingly central role in delivering CAR T-cell therapy, ultimately improving access, reducing geographical disparities, and advancing patient-centered cancer care.

Pipeline Snapshot: Where Cellular Therapies Are Heading Next

The next wave of cellular therapy innovation is focused on improving scalability, expanding indications, and integrating these treatments into broader oncology care pathways. A major area of development is allogeneic CAR T-cell therapies, which utilize donor-derived T cells to eliminate the need for individualized manufacturing and bypass the time-consuming, patient-specific manufacturing required for autologous CAR T-cell therapy. These approaches aim to improve product availability and enable treatment of patients with rapidly progressive disease, although challenges related to graft-vs-host disease and persistence remain under investigation.³²

An additional area of emerging interest is in vivo CAR T-cell generation, which seeks to eliminate the need for ex vivo cell collection and manufacturing.³³ This approach involves delivering genetic constructs, typically via viral vectors or lipid nanoparticles, directly into the patient to reprogram T cells within the body to express CARs.³³ By bypassing leukapheresis and centralized manufacturing, in vivo CAR T-cell therapy has the potential to dramatically reduce production time and lower costs.³³ Although still in early-stage development, preclinical studies and initial clinical investigations suggest feasibility.³³

Tumor-infiltrating lymphocyte (TIL) therapies are also gaining momentum, particularly in solid tumors where CAR T-cell efficacy has been limited.³⁴ By expanding and reinfusing tumor-reactive T cells harvested directly from the tumor microenvironment, TIL therapies offer a personalized yet potentially more adaptable approach for cancers such as melanoma.³⁴ In February 2024, the FDA approved the first personalized TIL therapy, lifileucel (Amtagvi; Iovance Biotherapeutics), for metastatic melanoma.³⁴

Additionally, there is growing interest in combining cellular therapies with other modalities, including checkpoint inhibitors, antibody-drug conjugates, and cytotoxic agents, to enhance durability and overcome resistance.³⁵ Digital innovations, including telehealth, remote patient monitoring, and data-driven care platforms, are expected to play a critical role in enabling decentralized delivery, supporting toxicity management, and facilitating broader adoption across community oncology settings.³⁶

In summary, CAR T-cell therapy has evolved from a highly specialized intervention into a more scalable and increasingly accessible treatment modality, driven by advances in clinical efficacy, safety management, and operational infrastructure. Expanding delivery into community oncology settings, supported by coordinated care models, workforce readiness, and reimbursement alignment, represents a critical next step in improving access and reducing disparities. At the same time, emerging innovations across the cellular therapy pipeline promise to further streamline delivery and broaden applicability. Together, these developments position CAR T-cell therapy for more integrated, equitable, and sustainable use in routine oncology care.

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