【AJH】Preliminary efficacy and safety of Ricky Orence injection in the treatment of relapsed/refractory follicular lymphoma in China

Follicular lymphoma (FL) is the second most common non-Hodgkin lymphoma, and the development of CAR-T cell therapy provides a new and effective treatment strategy for patients with relapsed/refractory (r/r) FL

The RELIANCE Study (NCT04089215) is a Phase I/II, single-arm, multicenter study evaluating Ricky Orensey injection for LBCL or FL in six tertiary hospitals in China, divided into A-arm (LBCL) and B-arm (FL).

Research methods

The authors analyzed patients

All subjects received leukocyte monoscopy to prepare CAR-T cells

The primary endpoint was CRR

Results of the study

patient

Of the 30 patients screened for r/r FL, 24 received relma-cel and were included in this study, plus four patients in the phase I study, and a total of 28 patients with r/r FL were included in the final analysis, of which 9 (32.

The median time from leukocyte single to relma-cel infusion was 34 days

efficacy

Of the 27 patients analysed for efficacy, the investigator-assessed 3-month CRR was 85.

security

In all 28 patients, the incidence of adverse events (TEAE) after treatment was 96.

Fifteen patients (53.

discuss

The ZUMA-5 study showed that CRR and ORR in patients treated with grade 1-3a r/r FL with axi-cel were 79% and 94%, respectively; In the Phase 2 ELARA study, tisagenlecleucel treated patients with grade 1-3a r/r FL with CRR of 69.

The incidence and type of AE in this study was comparable to that in previous CAR-T cell therapy studies, and no new safety issues were found

Overall, this Phase II study showed that fixed-dose Ricky Auronsay injection (100 × 106 cells or 150 ×¹⁰⁶ cells) had good short-term efficacy and safety in adult r/r FL patients in China, and that in adult r/r FL patients, fixed-dose Ricky Auronsail injection is a viable alternative

References

Zhitao Ying, Dehui Zou, Haiyan Yang,et al.

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