National Cancer Institute (NCI) Launches Clinical Trial for NGS Monitoring to Predict Relapse After Kymriah Therapy
NGS Monitoring for Leukemia Relapse After CAR-T Therapy
Novartis' Kymriah (tisagenlecleucel), a CD19-targeted CAR-T therapy, has become a standard treatment for pediatric and adolescent B-cell acute lymphoblastic leukemia (B-ALL) patients, demonstrating up to 50% long-term remission rates. However, patients who relapse after treatment often face difficulties in achieving second remission, making timely administration of high-risk treatments such as hematopoietic cell transplantation (HCT) crucial for survival. The CAR-CURE (NCT05621291) clinical trial by the National Cancer Institute (NCI) utilizes next-generation sequencing (NGS) technology to provide a model for real-time tracking of a patient's risk of relapse. This represents a prime example of precision medicine, organically combining diagnosis and treatment to improve cellular therapy outcomes.
Optimizing HCT Through Minimal Residual Disease (MRD) Tracking
This trial employs highly sensitive NGS MRD monitoring, such as Adaptive Biotechnologies' clonoSEQ, to precisely detect the presence of residual cancer cells in patients. Conventional flow cytometry has a sensitivity limit of 1 in 10,000, while NGS techniques can track minimal disease with a sensitivity of 1 in 1 million, enabling the detection of early relapse signs. This minimizes unnecessary high-risk HCT, preventing graft-related complications, and provides a basis for selectively performing early transplantation in high-risk patients. Consequently, it will contribute to reducing the physical burden and healthcare costs for patients after the administration of expensive therapies.
Competition and Value Reaffirmation in the CD19 CAR-T Market
In the global CD19 CAR-T market, Novartis' Kymriah recorded approximately $400 million in sales in 2025, but faced a 14% year-on-year decline due to the emergence of competitors such as Gilead's Tecartus and BMS' Breyanzi, leading to intense competition for market share. This study, which complements Kymriah's efficacy with NGS companion diagnostic technology, will serve as an opportunity to overcome the limitations of stand-alone administration, secure long-term survival data, and reaffirm the product's value. Furthermore, improved survival rates will lead to the establishment of partnerships with precision diagnostics platforms, providing new market expansion opportunities for liquid biopsy diagnostic companies.
Growth and Platform Advancement in the NGS MRD Diagnostics Market
Adaptive Biotechnologies, a leading provider of NGS MRD platforms used in the clinical trial, achieved $212 million in sales in its MRD business in 2025, a 46% year-on-year increase, and is on track to reach a maximum of $270 million in sales in 2026. If this protocol is established as a standard guideline, the number of NGS tests prescribed in clinical settings will increase, and insurance coverage will be expanded more rapidly. This signifies that diagnostic technology is being elevated to a key decision-making platform that determines the prescription efficiency of expensive therapies.
This pilot trial standardizes relapse prediction after the administration of expensive CD19 CAR-T therapies, which will greatly contribute to demonstrating the long-term clinical value of Novartis' Kymriah and competing drugs such as Breyanzi, which recorded sales of $400 million in 2025. Adaptive Biotechnologies' clonoSEQ NGS platform, a key tool in the trial, detects minimal residual disease (MRD) with a sensitivity of 1 in 1 million, reducing unnecessary hematopoietic cell transplantation (HCT) and promoting selective high-risk transplantation, thereby improving patient survival. In the short term, it will activate the business linkage between CAR-T cell therapy and NGS liquid biopsy diagnostics, and drive Adaptive's MRD sales from $212 million in 2025 to the upper end of its 2026 guidance of $270 million. In the medium to long term, it is expected to trigger revisions to global precision medicine and liquid biopsy diagnostics guidelines, accelerating the overall ecosystem of the cell therapy market, including joint development and licensing deals between major pharmaceutical companies and precision diagnostics developers.
Source: ClinicalTrials.gov (api_ct)