2 trials testing oral therapy for hard-to-treat myeloma are now recruiting
US developer raised over $30M this year to advance drug candidate
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Two clinical trials evaluating cemsidomide — an oral therapy candidate from C4 Therapeutics (C4T) that aims to limit cancer growth — in people with hard-to-treat multiple myeloma are now recruiting participants.
The U.S.-based developer also announced that it has raised more than $30 million that it will use to further advance clinical testing of cemsidomide. That funding will support upcoming trials, including a planned study of the experimental treatment used in other cemsidomide-based regimens, according to a company press release from C4T providing its latest financial results and business updates.
The more advanced current study, a mid-stage clinical trial dubbed MOMENTUM (NCT07284758), is testing the safety and effectiveness of cemsidomide plus dexamethasone, a standard myeloma treatment, in an estimated 100 adults. Eligible participants are those with multiple myeloma that is active despite at least three prior lines of treatment. Enrollment is ongoing at 20 sites in the U.S. and one in the U.K.
Also recruiting adults, also with myeloma that is relapsing or treatment-resistant, is a U.S. Phase 1b trial (NCT07280013) that’s assessing cemsidomide and dexamethasone in combination with Elrexfio (elranatamab), an approved myeloma therapy developed by Pfizer. That trial is seeking approximately 60 participants, with recruiting underway at certain sites across the country.
The Phase 2 MOMENTUM trial is expected to finish enrollment in early 2027, with initial results anticipated later that year, according to C4T. Interim data from the Phase 1b trial are expected this year, the company previously announced.
In addition to these trials, C4T is preparing to launch a new Phase 1b study next year to test cemsidomide as part of other regimens among people whose myeloma did not respond to prior lines of treatment.
Andrew Hirsch, C4T’s president and CEO, called “the first half of 2026 … a period of execution for cemsidomide, … and our clinical development plan.”
Now, Hirsch said, “as we enter the second half of the year, we remain focused on advancing the Phase 2 MOMENTUM trial, the Phase 1b combination trial with [Elrexfio] and start-up activities for our additional Phase 1b combination trial with approved standard-of-care multiple myeloma therapies.”
Cemsidomide aims to destroy proteins that help cancer grow
Cemsidomide, previously known as CFT7455, is designed to trigger the destruction of two proteins that myeloma cells rely on to survive and grow. By blocking these proteins — called IKZF1 and IKZF3 — the medication is expected to limit the cancer’s growth and help prevent disease progression.
Data from a previous Phase 1 trial (NCT04756726) involving 72 adults with hard-to-treat multiple myeloma showed that treatment with cemsidomide plus dexamethasone was well-tolerated and resulted in lasting responses.
To be eligible for MOMENTUM, patients must have previously received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Participants must also have received a T-cell engager or chimeric antigen receptor (CAR) T-cell therapy, unless these cutting-edge immune therapies are not available at the patient’s location.
All participants will receive cemsidomide once daily for the first 14 days of each 28-day treatment cycle, alongside dexamethasone on days 1, 8, 15, and 22 of each cycle. Treatment will continue until patients meet discontinuation criteria.
The trial’s main goal is to assess the overall response rate, or the proportion of participants experiencing a reduction in cancer burden, after about 3.5 years. Secondary goals include the duration of response, the time to response, and other measures of response and survival. Safety measures are also being evaluated.
In the ongoing Phase 1b trial, the first part is testing different doses of cemsidomide in combination with dexamethasone and Elrexfio in adults with multiple myeloma who have received two to four prior lines of therapy. The second part will test the selected cemsidomide dose in additional participants who have received one to three prior lines of treatment, including an immunomodulatory drug.
The main goal of that study is to evaluate the safety of cemsidomide plus Elrexfio, while secondary endpoints include assessment of the treatment’s anticancer activity and its ability to trigger the production of antibodies against it. The trial is also assessing the pharmacological properties of the combo therapy.
C4T will use $33.5M in funding for upcoming clinical trials
C4T noted that it raised approximately $33.5 million in net proceeds in the second quarter of this year, with the monies “expected to support the continued advancement of cemsidomide.” Specifically, according to the company, the funds will be used for the upcoming Phase 1b trial and “Phase 3 trial planning activities and execution efforts.”
That study will test two four-medication combinations in people with resistant and relapsing multiple myeloma. One regimen will use cemsidomide plus dexamethasone, Darzalex (daratumumab), and an anti-CD38 antibody-based therapy. The other combines cemsidomide with dexamethasone, a proteasome inhibitor, and carfilzomib (sold as Kyprolis and generics).
“Together, these studies are expected to generate clinical milestones in 2027 and beyond and will support our vision of establishing cemsidomide as a potential backbone therapy for combination regimens in multiple myeloma,” Hirsch said.
The company presented early data on cemsidomide at a medical conference in June.
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