China’s CAR-T Cell Therapy: Leading a New Revolution in the Treatment of Relapsed/Refractory Mantle Cell Lymphoma (MCL)
MCL
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Mantle Cell Lymphoma (MCL), a rare and complex subtype of non-Hodgkin’s lymphoma, exhibits both aggressive and indolent characteristics. Since MCL patients are usually diagnosed at an advanced stage, often with poor prognostic factors, traditional treatments such as chemotherapy and immunotherapy have brought survival benefits to some patients. However, most still face disease relapse or progression, particularly those with relapsed/refractory (r/r) MCL, where treatment poses significant challenges. For a long time, treatment options for MCL have been limited, making it difficult to achieve long-term remission or cure, highlighting the need for breakthroughs.
Chinese CAR-T Cell Therapy: Offering Hope for Relapsed/Refractory MCL With the rapid development of biotherapeutics, Chinese CAR-T cell therapy has emerged as a breakthrough innovation in lymphoma treatment. Since the approval of the world’s first CAR-T product in 2017, China has made significant progress in CAR-T research and application, especially in treating r/r MCL, where CAR-T therapy has shown excellent efficacy. CAR-T therapy not only significantly improves patient remission rates but also offers new survival opportunities for high-risk patients with poor prognoses.
Efficacy: In recent years, multiple international and Chinese clinical studies have confirmed the efficacy of CAR-T cell therapy in patients with relapsed/refractory MCL. Clinical data from China have also demonstrated outstanding results. In August 2024, the Chinese CAR-T product Relmacabtagene Autoleucel, a CD19-targeted CAR-T cell therapy, was approved for its third indication, treating adult patients with relapsed/refractory MCL (r/r MCL). Clinical data showed that Relmacabtagene Autoleucel achieved an overall response rate of 81.4%, with a complete response rate of 67.8%. The median progression-free survival (PFS) was 13 months, and the median overall survival (OS) was 19.5 months. These data further prove that Chinese CAR-T cell therapy not only has high efficacy in r/r MCL patients but also provides lasting survival benefits.
Side Effect Management: Despite its remarkable efficacy, CAR-T therapy is associated with certain side effects, such as cytokine release syndrome (CRS) and neurotoxicity (NT). However, with the continuous optimization of treatment technologies and accumulated experience in China, the incidence of side effects has been effectively controlled. In treating relapsed/refractory MCL patients, Chinese medical teams have been able to limit the occurrence of grade ≥3 CRS and NT to 6.8% in clinical practice. This lower toxicity makes CAR-T therapy safer in clinical applications, offering a new option for patients who cannot tolerate traditional treatments. Particularly for those who are resistant to Bruton’s tyrosine kinase inhibitors (BTKi) or ineligible for autologous hematopoietic stem cell transplantation, Chinese CAR-T therapy provides a gentler and effective treatment option.
Indications: The following groups of patients can benefit from Chinese CAR-T cell therapy:
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Patients with relapsed/refractory MCL (r/r MCL)
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MCL patients who do not respond to conventional treatments
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Patients with poor prognostic factors (TP53 mutation, Ki67≥30%, blastoid MCL, pleomorphic MCL, POD24)
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Patients previously exposed to BTKi or resistant/relapsed/refractory MCL
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High-risk patients unsuitable for transplantation who cannot achieve good remission