A Phase I/IIa study to assess the safety and biological activity of TdT-3, an autologous TCR T-cell therapy targeting TdT, in HLA-A*02:01+ patients aged ≥1 year with relapsed or refractory TdT+ acute leukemia or lymphoblastic lymphoma.
This study is looking into a new cell therapy called TdT-3 for children and adults (aged 1 year and older) who have specific blood cancers, acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL), that have returned or haven't responded to previous treatments. The main goals are to find a safe dose of TdT-3 and to understand any side effects it might cause. Researchers also want to see how well the body responds to the treatment and if it helps fight the cancer. This is an early-stage study, meaning it's one of the first times this treatment is being used in people.
At a glance
What is this study about?
This study is about a new type of treatment called **TdT-3**. This treatment uses your own immune cells, called T-cells, to fight cancer. Researchers take some of your T-cells, change them in a lab to recognise and attack specific cancer cells, and then give them back to you. This is a very targeted approach, aiming to be precise in how it tackles the cancer.
The study focuses on patients who have a type of blood cancer called acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL). These specific cancers have a marker called TdT. The TdT-3 treatment is designed to specifically target this marker. Patients in this study would be those whose cancer has come back after treatment, or hasn't responded to other treatments given.
This is an early-stage study, called Phase I/IIa. This means it's one of the first times this new treatment is being given to people. The main goals are to find a safe dose of TdT-3, understand any side effects it might cause, and see if it begins to show signs of working against the cancer. They are also checking how easy it is to prepare and deliver this special cell treatment to patients.
Key takeaways
- This study tests a new cell therapy (TdT-3) for certain blood cancers.
- It's for people aged 1 year or older whose cancer has returned or isn't responding to other treatments.
- The main goals are to find a safe dose and look for any side effects.
- Researchers also want to see if the treatment helps fight the cancer.
- Participation involves cell collection, treatment, and ongoing monitoring for up to two years.
Who may be eligible?
To be considered for this study, you would need to be at least one year old with no upper age limit. Both male and female patients can take part.
You would need to have certain types of blood cancer, specifically acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL), that has either come back after treatment or hasn't responded to your previous treatments. Your cancer cells must also have a specific marker called TdT.
There are other medical requirements related to your general health and specific genetic markers (HLA-A*02:01+ blood type) that the study team would check to make sure the treatment could potentially work for you and that taking part would be safe.
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 1 year old or older?
- Do you have acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL)?
- Has your cancer come back or not responded to previous treatments?
- Does your cancer have the TdT marker? (Your doctor can confirm this.)
- Do you have the HLA-A*02:01 genetic marker? (Your doctor can check this.)
What does participation involve?
If you join this study, the first step involves collecting your own T-cells, usually from your blood. These cells will then be sent to a special lab to be modified into the TdT-3 treatment. This process takes some time. Once your TdT-3 cells are ready, you would receive the treatment through an infusion, similar to a drip.
After receiving the treatment, you would have regular check-ups, blood tests, and other assessments for a period of time to monitor your health, look for any side effects, and see how your body is responding to the treatment. This close monitoring is very important in early-stage studies. The total duration of active participation with assessments and follow-up will vary for each person but will involve many visits, especially in the first month, and continued monitoring for up to two years to track long-term effects.
Potential risks and benefits
Locations (1)
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Common questions
What is acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL)?
These are types of cancer that start in white blood cells. ALL affects the blood and bone marrow, while LBL mainly affects the lymph nodes.
What does 'relapsed or refractory' mean?
It means the cancer has come back after treatment (relapsed) or hasn't responded to previous treatments (refractory).
What is TdT-3 therapy?
It's a special type of cell therapy that uses your own immune cells, called T-cells, which are modified to specifically find and kill your cancer cells.
What are 'side effects'?
Side effects are unwanted or unexpected effects of a medicine or treatment. The study team will monitor you closely for any side effects.
How long will I be involved in the study?
After receiving the treatment, you'll be monitored closely for weeks and then regularly for up to two years to see the long-term effects of TdT-3.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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