A phase 2 clinical trial (NCT04718883) has shown promising results for relmacabtagene autoleucel (relma-cel), an anti-CD19 CAR T-cell therapy, in patients with relapsed or refractory mantle cell lymphoma who had already failed at least two previous treatments, including BTK inhibitors. The study included 59 heavily pretreated patients with a median age of 59.
The therapy produced rapid and strong responses. After three months, the overall response rate was 71.2%, and 54.2% of patients achieved a complete response. The median duration of response was 18.1 months, while median progression-free survival reached 15.5 months and median overall survival was 19.5 months. Patients responded quickly, with the first response occurring in about one month.
However, significant side effects were common. Most patients developed blood-related toxicities such as neutropenia and leukopenia. Cytokine release syndrome occurred in 81.4% of patients, although the majority of cases were mild to moderate. The 12-month non-relapse mortality rate was 14.5%, with several deaths linked to infections such as COVID-19 or pneumonia rather than lymphoma progression. Relma-cel has now been approved in China for relapsed or refractory mantle cell lymphoma and may offer a new option for patients who have exhausted standard therapies.