328MO - The pivotal clinical study of IM19 CAR-T cells in the treatment of relapsed or refractory aggressive B cell non-Hodgkin lymphomas

Background

IM19 is an autologous, CD19-directed, chimeric antigen receptor (CAR) T-cell product, which is manufactured in China using a commercial process. We aimed to evaluate the efficacy and safety of IM19 in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphomas in a pivotal clinical study.

Methods

A phase Ib/II pivotal study was launched to evaluate the clinical outcomes of IM19 in relapsed or refractory (r/r) aggressive B-cell non-Hodgkin lymphomas at 18 sites in China. The recommended target dose was 3×10⁶ CAR-T cells/kg. Primary endpoint was ORR at 3 months. This trial is registered in ClinicalTrials.gov, and the number is NCT 04440436.

Results

As of the data cutoff on 15 June 2023, 99 patients underwent leukapheresis for manufacture of CAR-T cells (IM19), and 71 patients received IM19 treatment (there are still 15 patients to be infused). Among the 59 patients who underwent at least one efficacy evaluation, the primary endpoint of the 3-month ORR was 51%. The incidences of CRS and neurotoxicity were 42% and 7%, respectively; no patient experienced grade 3-4 CRS or grade 3-4 neurotoxicity.

Conclusions

IM19 treatment of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma can achieve a high rate of durable responses, with an extremely low incidence of grade 3 or more severe CRS and neurotoxicity.

Clinical trial identification

NCT04440436.

Editorial acknowledgement

Legal entity responsible for the study

Beijing Imunopharm Technology Co., Ltd.

Funding

Beijing Imunopharm Technology Co., Ltd.

Disclosure

T. He, F. Wu, G. Liu, Y. Ding, X. Lu: Financial Interests, Institutional, Full or part-time Employment: Beijing Imunopharm Technology Co., Ltd. All other authors have declared no conflicts of interest.