CASI Pharmaceuticals To Present Phase 1 CID-103 Data In Immune Thrombocytopenia At ASH 2025

- CID-103 is a potential best-in-class, anti-CD38 monoclonal antibody
- Phase 1 dose escalation study in Immune Thrombocytopenia (ITP) results and update

SOUTH SAN FRANCISCO, CA / ACCESS Newswire / November 3, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company developing CID-103, a potential best-in-class, clinical stage anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases, today announced that data will be presented from its Phase 1 open-label study of CID-103 in adult patients with immune thrombocytopenia (ITP) at the 67th American Society of Hematology Annual Meeting and Exposition being held December 6-9, 2025, in Orlando, Florida.

Poster Presentation Details

Title: A dose-escalation and safety study of CID-103 followed by a randomized, open-label, parallel-arm multi-dose study evaluating the efficacy and tolerability of CID-103 in adults with persistent or chronic immune thrombocytopenia

Authors: Chen Yunfei, ZePing Zhou, Hu Zhou, Ruibin Huang, Zhenyu Yan, Jun Peng, Ming Hou, James Bussel, Alexander Zukiwski, Junping Chen, Lei Zhang

Session Name: 311. Disorders of Platelet Number or Function: Clinical and Epidemiological: Poster II

Session Date and Time: Sunday, December 7, 2025, 6:00 p.m. - 8:00 p.m. PT

Location: Orange County Convention Center - West Halls B3-B4

About Phase 1 Dose-Escalating Study

In this multicenter, randomized, open-label, Phase 1 study, an estimated maximum of approximately 30 adults between 18 and 65 with primary ITP who had received at least two previous lines of treatment and whose mean platelet count was ≤ 35 x 109/L on at least two measurements at least one week apart were enrolled. This dose escalation study incorporated both accelerated escalation and standard 3+3 design. Patients were assigned to sequential dose cohorts of CID-103 at 30 mg, 150 mg, 300 mg, 600 mg, and 900 mg, with a priming dose of CID-103, of either 30 mg or 150 mg administered prior to the cohort dose. The Phase 1 study is designed to include multiple adaptative elements such as testing of intermediate, lower and higher doses if determined to be appropriate by the Safety Monitoring Committee (SMC).

This study is conducted under an FDA approved IND and a Clinical Trial Application (CTA) approved by the Chinese Center for Drug Evaluation (CDE).