Cullinan Therapeutics receives clearance for global Phase 1 2 study of velinotamig

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27.10.2026

Cullinan Therapeutics receives clearance for global Phase 1 2 study of velinotamig — Cullinan cleared for global trial

Cullinan Therapeutics announced that the U.S. FDA and Australian TGA have granted clearance to initiate a global Phase 1 2 clinical study of velinotamig. The study will evaluate this BCMAxCD3 T cell engager in patients with immune thrombocytopenia and warm autoimmune hemolytic anemia.

The regulatory clearances mark an important early milestone for Cullinan Therapeutics as it advances its investigational medicine targeting hematologic autoimmune conditions. Information on patient enrollment and study timelines was not specified in the announcement.

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Cullinan Therapeutics previously reported that zipalertinib showed intracranial antitumor activity in EGFR-mutated NSCLC with CNS metastases, according to a recent study. The company has also initiated a new drug application submission with the FDA for zipalertinib plus chemotherapy, developed in partnership with Taiho Oncology, targeting NSCLC patients, as detailed in a separate announcement. These developments highlight Cullinan Therapeutics’ ongoing efforts to advance its clinical pipeline in oncology and immune-related indications.

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