Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
LM-101, an Anti-SIRPα Antibody, in Patients with Relapsed/Refractory Lymphoma and Advanced Head and Neck Cancer: An Open-Label, Multicenter, Phase I Trial.
СтатьяКлиническое исследование I фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Cai Jun, Zhao Baitian, Ji Dongmei, Zhou Fuling, Bai Shenrui, Fang Xiaojie, Nie Man, Bai Bing, Zhang Yuchen, Li Jin, Li Haoyuan, Li Yuan, Fei Da, Qin Xia, Qin Crystal, Zhao Shuiyu, Xia Yi, Cai Qingqing
Аннотация
PURPOSE: The purpose of the study was to evaluate the safety and preliminary antitumor activity of LM-101, an anti-SIRPα antibody that blocks the CD47-SIRPα interaction, as monotherapy and in combination with rituximab or toripalimab in relapsed/refractory lymphoma and advanced head and neck cancer.
PATIENTS AND METHODS: Adult patients with relapsed/refractory lymphoma or advanced head and neck cancer were eligible. In the dose escalation phase, patients received LM-101 with accelerated titration at 3 mg/kg every 3 weeks, followed by a 3 + 3 escalation at 10, 20, 30, and 40 mg/kg. In the combination therapy safety lead-in phase, LM-101 was given at the recommended phase II dose (RP2D) with rituximab in lymphoma and with toripalimab in head and neck cancer. The primary objective was safety. Secondary objectives included antitumor activity (ClinicalTrials.gov: NCT05615974).
RESULTS: Between January 17, 2023, and October 6, 2025, 36 patients received LM-101 monotherapy (n = 17), LM-101 plus rituximab (n = 10), or LM-101 plus toripalimab (n = 9). No dose-limiting toxicities were observed. The RP2D was 40 mg/kg every 3 weeks. Grade ≥3 hematologic treatment-related adverse events (TRAE) included lymphopenia (5.9% with monotherapy; 40% with LM-101 plus rituximab), neutropenia (5.9%; 20%, respectively), and leukopenia (5.9%; 20%, respectively). Nonhematologic TRAEs were infrequent and predominantly grades 1 to 2. Objective response rates were 17.6% (3/17) with monotherapy and 50.0% (4/8) with LM-101 plus rituximab. Disease control rates were 75.0% (6/8) for LM-101 plus rituximab and 42.9% (3/7) for LM-101 plus toripalimab (with no objective responses observed).
CONCLUSIONS: LM-101 was well tolerated. The preliminary efficacy signal supports further evaluation of LM-101 plus rituximab in relapsed/refractory lymphoma.
PATIENTS AND METHODS: Adult patients with relapsed/refractory lymphoma or advanced head and neck cancer were eligible. In the dose escalation phase, patients received LM-101 with accelerated titration at 3 mg/kg every 3 weeks, followed by a 3 + 3 escalation at 10, 20, 30, and 40 mg/kg. In the combination therapy safety lead-in phase, LM-101 was given at the recommended phase II dose (RP2D) with rituximab in lymphoma and with toripalimab in head and neck cancer. The primary objective was safety. Secondary objectives included antitumor activity (ClinicalTrials.gov: NCT05615974).
RESULTS: Between January 17, 2023, and October 6, 2025, 36 patients received LM-101 monotherapy (n = 17), LM-101 plus rituximab (n = 10), or LM-101 plus toripalimab (n = 9). No dose-limiting toxicities were observed. The RP2D was 40 mg/kg every 3 weeks. Grade ≥3 hematologic treatment-related adverse events (TRAE) included lymphopenia (5.9% with monotherapy; 40% with LM-101 plus rituximab), neutropenia (5.9%; 20%, respectively), and leukopenia (5.9%; 20%, respectively). Nonhematologic TRAEs were infrequent and predominantly grades 1 to 2. Objective response rates were 17.6% (3/17) with monotherapy and 50.0% (4/8) with LM-101 plus rituximab. Disease control rates were 75.0% (6/8) for LM-101 plus rituximab and 42.9% (3/7) for LM-101 plus toripalimab (with no objective responses observed).
CONCLUSIONS: LM-101 was well tolerated. The preliminary efficacy signal supports further evaluation of LM-101 plus rituximab in relapsed/refractory lymphoma.