Clinical Trial Goal
To find out:
- The highest dose of KTX-1001 that’s safe to give
- If KTX-1001, alone or in combination with standard care, is safe and works well to treat multiple myeloma that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have multiple myeloma that has relapsed or is refractory
- Have not had an autologous (your own cells) blood or marrow transplant (BMT) in the last 3 months
- Have not had an allogeneic (cells from a donor) BMT in the last 6 months
- Have not had one of the following:
- Bone lesions
- Myelodysplastic syndrome (MDS)
- Myeloproliferative neoplasm (MPN)
- Plasma cell leukemia
- POEMS sydrome
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Carfilzomib is a small molecule inhibitor that blocks proteasome function in certain cells.
KTX-1001 is a small molecule inhibitor that targets MMSET on certain cells.
Mezigdomide is an immunomodulatory drug that doctors think will help fight cancer cells.
Pomalidomide is a drug that blocks the growth of cancer cells.
You’ll be placed in 1 of 3 groups:
KTX-1001 is a small molecule inhibitor that targets MMSET on certain cells.
Mezigdomide is an immunomodulatory drug that doctors think will help fight cancer cells.
Pomalidomide is a drug that blocks the growth of cancer cells.
You’ll be placed in 1 of 3 groups:
- Group 1 - KTX-1001
- Group 2 - KTX-1001 plus carfilzomib
- Group 3 - KTX-1001 plus mezigdomide
- Group 4 - KTX-1001 plus pomalidomide
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
- Carfilzomib - Group 2 only - Given as an intravenous (IV) infusion 1 time each week for 3 weeks
- KTX-1001 – A pill that you take by mouth1 time each day. The dose you'll get depends on when you start the trial and how safe it has been
- Mezigdomide - Group 3 only - A pill that you take by mouth 1 time each week
- Pomalidomide - Group 4 only - A pill that you take by mouth 1 time each day for 3 weeks
You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have biopsies to see how well the treatment is working.
The Food and Drug Administration (FDA) has approved not yet approved KTX-1001 or mezigdomide. The FDA has approved carfilzomib and pomalidomide in the treatment of multiple myeloma.
Contacts
Soo Bang, MHSA, 1-347-342-7199, sbang@k36tx.com
Miriam Barnett, Ph.D., 1-716-523-2141, mbarnett@k36tx.com
Locations
Sponsors
collaborator: Bristol-Myers Squibb, lead: K36 Therapeutics, Inc.
