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.
Who Can Participate?
Eligibility
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
For more information about who can join this study, please contact the study team at 919-681-6580.
- 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
For more information about who can join this study, please contact the study team at 919-681-6580.
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:
- Have a physical exam
- Have blood draws
- Answer questionnaires
- Have heart scans (ECG and echocardiogram)
- Give urine samples
- 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
- Have physical exams
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:
- Have a physical exam
- Have blood draws
- Answer questionnaires
- Have heart scans (ECG and echocardiogram)
- Give urine samples
- 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
- Have physical exams
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
Danielle
Brander
Protocol Number
PRO00108139
NCT ID
NCT04704323
Phase
I
Enrollment Status
OPEN TO ACCRUAL