A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)
This clinical trial, called CARDINAL, is looking into a new drug, TERN-701, for adults who have a type of blood cancer called Chronic Myeloid Leukemia (CML) in the chronic phase. These are people whose CML hasn't responded as expected to previous treatments. The study has two main parts. The first part focuses on finding the safest and most effective dose of TERN-701. The second part then uses these doses to see how well the medicine works and compare it in more people. There's also a smaller part for those with specific genetic changes in their CML. TERN-701 is designed to specifically target the cause of CML. Researchers want to understand if it's a good and safe option for patients who need new treatment choices.
At a glance
What is this study about?
This study is about a new treatment called TERN-701 for a type of blood cancer known as Chronic Myeloid Leukemia, or CML. CML is a long-lasting condition where too many white blood cells are made. Regularly, people with CML are treated with other medicines, but sometimes these don't work as well as hoped, or cause side effects that are too difficult to manage. This study offers a new option for these patients.
TERN-701 works by targeting a specific protein (called BCR-ABL1) that is responsible for CML. Researchers want to find out if this new medicine is safe, what the right dose is, how the body handles it, and how effective it is at treating CML. This is a "Phase 1/2" study, meaning it's still in the earlier stages of testing new drugs in people.
The study is divided into different stages. Initially, a small group of patients will try increasing doses of TERN-701 to find the safest and most effective amount (this is called Part 1, or Dose Escalation). Once the researchers have a better idea of the right doses, more patients will join (Part 2, or Dose Expansion) to further check how well the treatment works and its safety. There's also a specific group (Part 2m) for patients whose CML has certain genetic changes that might make it harder to treat.
Key takeaways
- New medicine (TERN-701) for CML in chronic phase.
- For those whose previous CML treatments haven't worked well.
- Study checks safety, best dose, and effectiveness of TERN-701.
- Involves taking daily medicine and regular clinic visits.
- Participants will receive the active study drug, not a placebo.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be at least 18 years old and have a confirmed diagnosis of Chronic Myeloid Leukemia (CML) in its chronic phase. Importantly, your CML should have been treated before with at least one other CML medicine, but it hasn't responded well enough, or you've found the side effects too difficult. You'll also need to be generally well enough to take part, as assessed by the study doctors.
There are also some reasons why you wouldn't be able to join. For example, if you've recently had other cancer treatments in the last 7 days, or if you still have significant side effects from previous treatments. The study doctors will carefully check all your medical information to make sure this study is right for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a diagnosis of Chronic Myeloid Leukemia (CML) in the chronic phase?
- Have you tried at least one other CML treatment that didn't work well or caused difficult side effects?
- Are you generally well enough for a clinical study?
- Have you avoided other cancer treatments in the last 7 days?
- Are any major side effects from previous treatments resolved or well-controlled?
What does participation involve?
If you join this study, you will take TERN-701 as a once-daily medicine. This treatment will be given in cycles, with each cycle lasting 28 days. You'll continue taking the medicine every day over these cycles.
During the treatment, you will have several scheduled visits to the study centre. In the first cycle, you'll have visits on Day 1, Day 2, Day 8, Day 15, and Day 16. For Cycles 2 through 7, you'll visit on Day 1 of each cycle. After that, you'll visit on Day 1 of every third cycle. These visits are important so the study team can monitor your health, check how you're responding to the treatment, and manage any side effects. Approximately 180 people might join this study.
Potential risks and benefits
Locations (54)
- University of Alabama Medicine (UAB Medicine)Verified postcodeBirmingham, United States· Recruiting
- Banner MD Anderson Cancer CenterVerified postcodeGilbert, United States· Recruiting
- UC Irvine HealthVerified postcodeOrange, United States· Recruiting
- Rocky Mountain Cancer Centers, LLPVerified postcodeLone Tree, United States· Recruiting
- Florida Cancer Specialists - South Region Research OfficeVerified postcodeFort Myers, United States· Not yet recruiting
- Florida Cancer Affiliates - OcalaVerified postcodeOcala, United States· Recruiting
- Florida Cancer Specialists - North Region Research OfficeVerified postcodeSt. Petersburg, United States· Not yet recruiting
- Florida Cancer Specialists - East Region Research OfficeVerified postcodeWest Palm Beach, United States· Not yet recruiting
- Georgia Cancer Center at Augusta UniversityVerified postcodeAugusta, United States· Recruiting
- Memorial Sloan Kettering Cancer Center - Main CampusVerified postcodeNew York, United States· Recruiting
- Atrium Health Levine Cancer InstituteVerified postcodeWinston-Salem, United States· Recruiting
- Willamette Valley Cancer Institute and Research CenterVerified postcodeEugene, United States· Recruiting
Common questions
What is CML?
CML stands for Chronic Myeloid Leukemia, which is a type of cancer that affects the blood and bone marrow, causing the body to produce too many white blood cells.
What is TERN-701?
TERN-701 is a new medicine being tested. It's designed to specifically target the cause of CML, particularly in people whose current treatments haven't worked well.
Why are there different 'parts' to the study?
The study has different parts to safely find the best dose (Part 1) and then to test that dose in more people to see how effective it is and understand its safety further (Part 2 and Part 2m).
How often will I need to visit the clinic?
You'll have more frequent visits at the beginning of the study, especially during the first cycle, and then less often as the treatment continues, typically once every three cycles after the seventh cycle.
Will I definitely receive the new drug?
Yes, everyone who joins this study will receive the active study medicine, TERN-701, at a specific dose.
How to find out more
Study Director
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.