Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma

To join this study, you need to be an adult, aged 18 or older, and have a confirmed diagnosis of active multiple myeloma. Your doctors must have assessed that you are likely to live for more than 12 weeks, and your general health and fitness, as measured by a specific scale, should be good enough to take part.

You must have already received several standard treatments for multiple myeloma, including certain types of medicines (like immunomodulatory drugs, proteasome inhibitors, and anti-CD38 treatments). Importantly, your cancer must either have stopped responding to these treatments or they couldn't be tolerated. Also, your cancer needs to be 'measurable,' meaning your doctors can track its presence and size.

There are also reasons why you might not be able to join. For instance, if you have certain other serious health conditions, or if the cancer has spread to your brain or spinal cord. If you've recently had a stem cell transplant or radiation therapy, or if you have certain active infections like HIV or hepatitis, you wouldn't be able to participate. Also, if you've already had a treatment that specifically targets something called BCMA (for those entering the second part of the study), you wouldn't be eligible.

If you join this study, you would receive the new study medicine, HDP-101. The study starts with a phase to find the safest and most effective dose, where a small group of people will receive carefully chosen doses. Once the best dose is found, more people will join to get that specific dose and help gather more information.

Throughout your time in the study, you would have regular visits to the hospital or clinic. During these visits, doctors and nurses would perform various checks. This includes blood tests to see how the medicine is working and how your body is handling it, as well as scans or other tests to monitor your multiple myeloma. The study team will explain exactly how often these visits will be.

The exact duration of your participation would depend on how your body responds to the treatment and the study plan. You would have regular check-ups to monitor your health and the progress of your cancer. All visits, tests, and the study medicine, HDP-101, would be provided as part of the research – you wouldn't have to pay for them.