CM-HZ01: a new high-boost IL-2 therapy for advanced melanoma
Official title: Development of CM-HZ01 as a non-alpha-IL2 therapeutic for the treatment of metastatic melanoma
Funded at Celdara Medical, LLC · NIH-11251635 · Data updated 2026-11-12
A new IL-2 based treatment called CM-HZ01 is being developed to help people with metastatic melanoma by steering the immune system toward stronger anti-tumor activity with potentially fewer side effects.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Celdara Medical, LLC NIH-funded |
| Lab location | 1 site (Lebanon, United States) |
| Project start | January 1, 2025 |
| Project end | April 30, 2027 |
| Funding year | 2026 |
| Award (this year) | $1,024,401 |
| NIH project number | 5R44CA298512-02 |
| Project ID | NIH-11251635 on NIH RePORTER |
Who could benefit from this research
✓Could help
Patients with metastatic melanoma who may be candidates for a future IL-2–based therapy, pending regulatory approval.
✕Less likely to help
Patients whose tumors do not respond to IL-2–based strategies or who are not eligible for such therapies may not benefit.
What this research studies
This project aims to move CM-HZ01 from early development toward testing in people, with the goal of filing an IND for metastatic melanoma. Researchers are engineering a high-avidity IL-2 molecule that favors CD8 T-cells and NK cells to attack melanoma tumors while reducing unintended toxicity. The work combines protein design, preclinical testing, and plans for clinical advancement to bring a next-generation immunotherapy closer to patients who have few effective options. If successful, this could lead to a new, more targeted treatment pathway for metastatic melanoma.
Why it matters
Potential benefit: If successful, CM-HZ01 could become a new, more powerful and potentially better-tolerated immunotherapy for metastatic melanoma.
How similar studies have gone: IL-2 based immunotherapies have shown activity in melanoma, but CM-HZ01 aims to improve selectivity and reduce toxicity.
Where this research is happening
-
Celdara Medical, LLC
Lebanon, United States Active
Researchers
- Principal investigator: Cooper, Colleen Doyle — Celdara Medical, LLC
- Study coordinator: Cooper, Colleen Doyle
Related research
Other NIH-funded projects on the same topics.
-
Harnessing human CD1d-NKT cells to boost melanoma immunotherapy
A small NIH-funded project tests a new approach that uses a special type of immune cell to help treat metastatic melanoma in patients.
-
New tubulin-blocking agents for metastatic melanoma
A new class of tiny molecules called fused heterocyclic pyrazines will be studied as potential anti-melanoma drugs, aimed at patients with metastatic melanoma.
-
New anti-mitotic drugs for metastatic melanoma
Developing new medicines that stop cancer cells from dividing to help people with metastatic melanoma, including tumors that resist current chemotherapy.
-
Investigating how dormant melanoma cells can reactivate and promote cancer growth.
This study is looking at how sleeping melanoma cells can affect nearby cells to help the cancer grow and resist treatment, and it's designed for researchers like Dr. Fane to learn new ways to find better treatments for melanoma.
-
Developing a new treatment for metastatic melanoma using a specialized form of interleukin-2.
This study is testing a new treatment called CM-HZ01 that helps boost your immune system to fight metastatic melanoma by specifically activating certain immune cells, aiming to make the existing IL-2 therapy work better with fewer side effects for patients who don’t have many options left.
-
Improving detection of early-stage metastatic melanoma using advanced microscopy
This study is testing a new imaging technique to help doctors better identify early-stage melanomas that have spread, so patients can get the right treatment sooner and improve their chances of recovery.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.