Trial reportJournal of hematology & oncology2024
Safety and efficacy of amulirafusp alfa (IMM0306), a fusion protein of CD20 monoclonal antibody with the CD47 binding domain of SIRPα, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: a phase 1/2 study.
Trial report in Journal of hematology & oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05805943 (Phase I/II Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma), which is not on this map. Cited by 12 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase I/II Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma
Who cites it
12 citing papers in PubMed.
- Abexinostat, a histone deacetylases inhibitor, for patients with relapsed or refractory follicular lymphoma: a multi-center, single-arm phase 2 study.Signal transduction and targeted therapy · 2026Trial
- Recent advances in the regulation of CD47 by non-coding RNAs and its therapeutic potential in cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Review
- Glioma microenvironment: Cellular crosstalk, immunosuppression, and novel therapeutic perspectives.Chinese medical journal · 2026Review
- Follicular Lymphoma: Novel Therapies and Strategies for Optimal Therapeutic Sequencing.Current oncology reports · 2026Review
- CD155 links tumor immunotype to epithelial-directed precision therapy beyond checkpoint inhibition in cervical cancer.Journal for immunotherapy of cancer · 2026Article
- Immune Checkpoint Inhibitors and Immunomodulators for Cancer Immunotherapy: Insights Into Resistance and Therapeutic Strategies.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- Targeting the CD47/SIRPα interaction in cancer: opportunities in non-Hodgkin lymphoma.Expert opinion on investigational drugs · 2026Review
- Ir(III) Complexes Convert Cold to Hot Tumors via Ferroptosis/Necroptosis-Driven Immunogenic Cell Death and Photosensitized CD47 Downregulation.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- MYC-positive follicular lymphoma complicated by refractory lactate and clonal evolution: a case report.Frontiers in oncology · 2026Article
- Unraveling novel therapeutic targets for diffuse large B-cell lymphoma: a plasma multi-omics study.Frontiers in pharmacology · 2026Article
- Immune checkpoint inhibitors for the treatment of solid tumors and lymphoma in the past 26 years (2000-2025).Journal of hematology & oncology · 2025Review
- Post-translational modifications of cancer immune checkpoints: mechanisms and therapeutic strategies.Molecular cancer · 2025Review
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAmulirafusp alfa (IMM0306) is a fusion protein of CD47 binding domain of signal-regulatory protein alpha (SIRPα) with CD20 monoclonal antibody on both heavy chains. This study aimed to evaluate the safety and preliminary efficacy of amulirafusp alfa in relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL).
methodsWe enrolled patients with CD20 + r/r B-NHL who had previously received at least two lines of therapy to receive a single-dose of amulirafusp alfa in the first 2 weeks, followed by a multiple-dose period, in which the patients received the same intravenous dose every week in 4-week cycles. The primary endpoints were to evaluate the safety, determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of amulirafusp alfa.
resultsBetween May 22, 2020 and February 10, 2022, 48 patients with r/r B-NHL were enrolled and received amulirafusp alfa at the doses of 40-2000 μg/kg. As of the data cut-off date of April 18, 2024, no dose-limiting toxicity was observed, and the MTD was not reached. The dose of 2000 μg/kg was identified as the RP2D. All grades and ≥ grade 3 treatment-related adverse events (TRAEs) occurred in 48 (100%) and 33 (68.8%) patients, respectively. The most common ≥ grade 3 TRAEs were lymphocyte count decreased (28/48, 58.3%), white blood cell count decreased (10/48, 20.8%), absolute neutrophil count decreased (9/48, 18.8%) and anemia (5/48, 10.4%). At the doses of 800-2000 μg/kg, objective response rate in follicular lymphoma and marginal zone lymphoma was 41.2% (7/17, 95% confidence interval [CI] 18.4-67.1) and 33.3% (2/6, 95% CI 3.7-71.0), respectively.
conclusionAmulirafusp alfa showed favorable safety profile and preliminary efficacy in patients with r/r B-NHL, meriting further investigation. Trial registration NCT05805943.
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