Preliminary results from a phase I/II study of IMM0306, a CD47 and CD20 bispecific monoclonal antibody-trap, in patients with relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma.

• DOI: 10.1200/jco.2023.41.16_suppl.7527
• Publication Date: 2023-06-07T16:48:12Z
• Authors: Jianliang Yang; Yongping Song; Zhiming Li; Mingzhi Zhang; Keshu Zhou; Zhen Wang; Hongmei Jing; Li Yu; Huizi Ma; Xiwen Zhao; Wei Li; Wei Meng; Wenzhi Tian; Yuankai Shi
• Keywords: Refractory (planetary science)

7527 Background: IMM0306 is a fusion protein of CD20 monoclonal antibody with the CD47 binding domain SIRPα on both heavy chains. It has higher affinity for than CD47, thus enabling its preferential and simultaneous to malignant B cells rather CD47-postive normal tissues. Here, we report safety, pharmacokinetics (PK), pharmacodynamics (PD), efficacy results dose escalation stage in phase I/II study patients (pts) relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma. Methods: This first-in-human, open-label, IMM0306. The ongoing Phase I part (0.04, 0.1, 0.25, 0.5, 0.8, 1.2, 1.6, 2.0 mg/kg, IV) followed an accelerated titration standard 3+3 design. was administered once per week after 2-week single-dose period, until disease progression intolerable toxicity. Dose-limiting toxicity (DLT) evaluated first 28 days. Safety CTCAE 5.0, tumor assessments performed every 8 weeks, PK PD were also assessed. Results: As data cut-off date Dec 15 th , 2022, 42 pts enrolled. 18 (43%) received 3 more prior lines therapy, all anti-CD20 therapy. No DLTs observed up mg/kg. most frequent treatment related adverse events (TRAEs) lymphocyte decreased (61.9%), white blood cell (WBC) anemia (59.5%), neutrophil (ANC) (40.5%), platelet (PLT) infusion-related reactions (31.0%). Grade ≥ TRAEs occurred 30 (71.4%) pts, grade WBC (16.7%), ANC (11.9%). Three SAEs PLT (grade 4), chest pain 2) diarrhea 3). In 38 response evaluable 2 follicular lymphoma (FL) achieved CR, 1 marginal zone (MZL) pt FL PR 13 showed SD. 26 treated at doses 0.8 among whom 11 pts. Of these 4 (36%) responded including CR 1.2 mg/kg 1.6 respectively. exhibited approximate dose-proportional increase exposure from 0.5 no obvious accumulation repeated dosing. counts depleted rapidly Elevated cytokines levels dosing IMM0306, but multiple did not stimulate further cytokine activation. Conclusions: well-tolerated robust preliminary anti-tumor activity especially R/R MZL. ongoing. Clinical trial information: CTR20192612 .