OK given for testing higher dose of ITP treatment CID-103 in study
Developer assessing safety of 5 doses of infusion therapy at 6 sites in China
Casi Pharmaceuticals has been given the all-clear to start dosing a fifth group of patients in a clinical trial testing its treatment candidate CID-103 in people with chronic immune thrombocytopenia (ITP).
This group will receive the highest dose of the medication — 900 mg — tested to date, according to a company press release.
The Phase 1/2 clinical trial (NCT07017725), which is still recruiting, is expected to enroll 75 adults at six sites in China. All participants in the study will receive weekly infusions of CID-103 at a set dose for six weeks, then infusions every other week up to week 12. Patients may then receive monthly infusions up to study month six.
The first part of the dose-escalation study is testing at least five different doses of CID-103, with the main goal of assessing safety. The first four groups of patients in the study received a target dose of 30, 150, 300, and 600 mg, respectively.
A safety monitoring committee has now reviewed data from those groups and given the okay for the trial to proceed to a fifth planned group that will test a target dose of 900 mg. According to Casi, there haven’t been any serious safety issues reported in the trial so far.
“We are pleased with the safety and tolerability of CID-103 based on these initial cohorts of patients, and encouraged by the [safety monitoring committee]’s recommendation to proceed,” said Alex Zukiwski, MD, Casi’s chief medical officer. “We look forward to reporting clinical results at an upcoming medical congress.”
According to the developer, CID-103 is “a potential best-in-class” treatment for IPT, and the “safety profile observed in [the] first four dose [groups] supports [its] continued development.”
Casi noted that no serious adverse events have been reported, and further, that there have been no dose-limiting toxicities seen to date in the study.
Trial’s second part to test 3 doses of ITP treatment in more patients
The ongoing trial is now enrolling patients, ages 18 to 65, whose ITP has lasted for at least three months. Eligible participants will have received at least two prior lines of standard-of-care ITP treatment.
Based on the results from the first part of the trial, up to three doses of CID-103 will be selected for testing in a larger number of patients in the second part of the study, which aims to assess the therapy’s effect on platelet levels.
ITP is an autoimmune disorder in which antibodies mark the body’s healthy platelets — cell fragments involved in clotting — for destruction, causing their levels to plummet. Disease-driving antibodies in ITP are made mainly by specialized immune cells called plasma cells.
CID-103 is an antibody-based therapy that targets CD38, a protein found on plasma cells and other immune cells. By targeting this protein, the therapy aims to deplete disease-driving immune cells, thereby restoring platelet levels and normalizing clotting in ITP.
Casi noted that the study has been cleared by the U.S. Food and Drug Administration and the Chinese Center for Drug Evaluation in China.
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