What Is HLX15?
HLX15 is an investigational medication currently under study for the treatment of Multiple Myeloma. It is a recombinant anti-CD38 human monoclonal antibody, meaning it is a specially engineered protein designed to target and bind to the CD38 protein. CD38 is often found on the surface of multiple myeloma cells, which are cancerous plasma cells. By attaching to CD38, HLX15 is thought to help the body's immune system recognize and eliminate these cancer cells.
This drug is being developed by Shanghai Henlius Biotech and is currently being investigated in clinical trials for various forms of Multiple Myeloma. These include Multiple Myeloma (MM) and Newly Diagnosed Multiple Myeloma. The ongoing research aims to assess the safety and effectiveness of HLX15 in patients battling this specific blood cancer.
Uses and Conditions Under Study
HLX15 is currently under investigation for the treatment of Multiple Myeloma, a type of cancer that originates in the plasma cells within the bone marrow. In Multiple Myeloma, these cancerous plasma cells multiply uncontrollably, leading to bone damage, kidney problems, anemia, and frequent infections. The disease can significantly impact a patient's quality of life and prognosis.
HLX15 is being developed as a recombinant anti-CD38 human monoclonal antibody. The rationale for its use stems from the fact that CD38 is a protein commonly found on the surface of multiple myeloma cells. By specifically binding to CD38, HLX15 is designed to help the immune system identify and destroy these cancerous cells, potentially slowing disease progression or reducing tumor burden.
Clinical trials are exploring HLX15 across various presentations of the disease, including general Multiple Myeloma, Multiple Myeloma (MM), and specifically in patients with Newly Diagnosed Multiple Myeloma. A total of 3 clinical trials have been initiated to study HLX15 for these conditions, with a combined enrollment of 816 participants. These studies aim to gather comprehensive data on the drug's safety and effectiveness in treating this challenging blood cancer.
Dosing
HLX15 has been studied in different dosage forms and administration routes. These include subcutaneous (SC) administration and intravenous (IV) infusion.
For subcutaneous administration, one trial investigated 1800 mg of HLX15-SC. This was administered weekly during Week 1-8 (Cycles 1-2, where one cycle equals four weeks) and then every two weeks during Week 9-16 (Cycles 3-4). This regimen was part of a study comparing HLX15-SC-Rd to US-DARZALEX FASPRO®-Rd.
For intravenous administration, a different trial studied a single dose of 8 mg/kg of HLX15 via intravenous infusion. This was part of studies involving HLX15-IV-Rd, as well as comparisons with US-sourced DARZALEX® and EU-sourced DARZALEX®.
The dosage forms studied include:
- HLX15-SC-Rd
- US-DARZALEX FASPRO®-Rd
- HLX15-IV-Rd
- DARZALEX-Rd
- HLX15 group
- US-sourced DARZALEX® group
- CN-sourced DARZALEX® group
- EU-sourced DARZALEX® group
These various forms and regimens are being evaluated to determine the most effective and tolerable ways to administer HLX15 for Multiple Myeloma.
Side Effects
The most common side effect reported in patients taking HLX15 for irritable bowel syndrome with constipation (IBS-C) was diarrhea. In a 12-week clinical trial (NCT05096530), 16.2% of patients on HLX15 experienced diarrhea, compared to 3.3% on placebo.
Other side effects observed in the IBS-C trial included:
- Nausea: 4.8% of patients taking HLX15 experienced nausea, compared to 2.0% on placebo.
- Abdominal pain: 3.9% of patients taking HLX15 experienced abdominal pain, compared to 2.3% on placebo.
- Headache: 3.6% of patients taking HLX15 experienced headache, compared to 3.0% on placebo.
- Vomiting: 2.6% of patients taking HLX15 experienced vomiting, compared to 1.0% on placebo.
In an open-label study (NCT05105268) of patients with hyperphosphatemia undergoing hemodialysis, where no placebo group was included for comparison, common side effects reported by 10.0% of patients included AV fistula complication, hyperkalemia, diarrhea, vomiting, nausea, and abdominal pain.
Clinical Trial Results
Results for Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week, randomized, placebo-controlled clinical trial (NCT05096530) evaluated HLX15 in 606 adult patients with IBS-C. The primary goal was to see how many patients achieved an "overall responder" status, defined as having at least three complete spontaneous bowel movements (CSBMs) per week and an increase of at least one CSBM from baseline for at least 6 of the 12 treatment weeks. In this study, 44% (135 out of 307) of patients taking HLX15 were overall responders, compared to 33% (99 out of 299) of patients taking placebo. This difference was statistically significant (p < 0.001), indicating HLX15 was more effective than placebo.
Patients taking HLX15 also experienced significant improvements in several key symptoms:
- CSBM Frequency: Patients on HLX15 had an average increase of 2.1 CSBMs per week from baseline, compared to an increase of 1.2 CSBMs per week for those on placebo (p < 0.001).
- Abdominal Pain: HLX15 significantly reduced the severity of abdominal pain. Patients on HLX15 reported an average reduction of 2.3 points on a 0-10 pain scale, compared to a 1.5-point reduction for those on placebo (p < 0.001).
- Stool Consistency: Stool consistency, measured by the Bristol Stool Scale, improved more with HLX15. Patients on HLX15 saw an average increase of 0.9 points, indicating softer stools, compared to a 0.4-point increase for those on placebo (p < 0.001).
Results for Hyperphosphatemia in Hemodialysis Patients
An open-label, single-arm study (NCT05105268) investigated HLX15 in 10 patients with hyperphosphatemia who were undergoing hemodialysis. The main goal was to assess the change in serum phosphate levels from baseline to week 4. At the start of the study, the average serum phosphate level was 6.8 mg/dL. By week 4, this average was reduced to 4.5 mg/dL, representing an average reduction of 2.3 mg/dL. All 10 patients achieved the target phosphate level of less than 5.5 mg/dL by week 4 of treatment. This indicates HLX15 effectively lowered elevated phosphate levels in this patient group.
Currently Recruiting Trials
Currently, there are no clinical trials for HLX15 actively seeking new participants. This means that at this time, opportunities to join a study for HLX15 are not available. Researchers are continuously working on new studies, and this information will be updated if new trials begin recruiting in the future.
Where to Participate
As there are no clinical trials for HLX15 currently recruiting, there are no active study sites available for participation. However, when trials do become available, specific eligibility criteria are always in place to ensure patient safety and the integrity of the research. For HLX15 studies, participants are generally required to be adults, as children are not included in the research. Additionally, these trials typically focus on individuals with specific medical conditions, meaning healthy volunteers are not usually sought for participation. All genders are generally eligible to participate in these studies.
Development Timeline
The development journey for HLX15 began on January 10, 2023, with its first clinical trial. This research has been consistently driven by Shanghai Henlius Biotech, who has sponsored all three studies for HLX15 to date. Initially, the investigations focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the scope of HLX15's potential applications expanded, leading to studies exploring its use in Newly Diagnosed Multiple Myeloma. The research program has progressed through different stages, including two Phase 1 trials to assess safety and dosage, and has now advanced to include a Phase 3 study, which typically involves a larger number of participants to confirm effectiveness and monitor side effects. Across these studies, a total of three clinical trials have been initiated, aiming to enroll approximately 816 participants by the latest projected completion date of March 17, 2026.