Catapult: Ph1a/b CAP-100 (Chronic Lymphocytic Leukemia) - Clinical Trial

Email to Participate

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called CAP-100 (study drug) is a safe and effective treatment for people who have CLL or SLL that is not responding to standard treatments. We also want to know what dose of this study drug works best.

What is the Condition Being Studied?

Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL).

Who Can Participate in the Study?

Adults ages 18+ diagnosed with CLL or SLL who:

Have relapsed after standard therapies; OR
Did not have an adequate response to standard therapies
Have not received an allogeneic (donor cells) stem cell transplant in the past 6 months

Para obtener más información sobre quién puede participar en este estudio, comuníquese con el equipo del estudio al 919-681-6580.

Grupo etario

Adultos

What is Involved?

This study has 3 parts: a screening period, a study drug period, and a follow-up period.

If you choose to join this study, you will begin a screening period to see if you are eligible. During the screening period, you will:

Hacer un examen físico
Realizar extracciones de sangre
Responder encuestas
Have heart scans (ECG and echocardiogram)
Proporcionar muestras de orina
Have a CT scan
Have a bone marrow exam (aspiration)

If you are eligible to continue on to the study drug period, you will:

Be assigned to receive a certain dose of the study drug
Receive the study drug through a vein in your arm (IV)
Be dosed with the study drug for 6 treatment cycles

The dose you are selected to receive will depend on when you join the study. You will receive this same dose every time you get the study drug.

Each treatment cycle lasts for 28 days. During cycle 1, you will get the study drug once a week for 4 weeks. During cycles 2-6, you will get the study drug only 1 time for each cycle.

You will begin the follow-up period when cycle 6 ends. During the follow-up period, you will:

Have blood draws and other tests
Have CT scans
Someterse a exámenes físicos

Study Details

Full Title

An open label Phase Ia/b dose escalation followed by dose expansion safety and tolerability trial of CAP-100, a humanized C-C-chemokine receptor 7 antibody, administered as monotherapy in subjects with r/r chronic lymphocytic leukemia.

Principal Investigator