Purpose of this Study
We are doing this study to find out if an experimental drug called NT-I7 is a safe and effective treatment for people with LBL. The study drug will be combined with Kymriah, which is an approved, standard treatment for LBL.
Who Can Participate?
Eligibility
Adults diagnosed with LBL who:
- Have relapsed from previous treatment; OR
- Did not have an adequate response to standard treatments
For more information about who can join this study, please contact the study team at peggy.alton@duke.edu.
- Have relapsed from previous treatment; OR
- Did not have an adequate response to standard treatments
For more information about who can join this study, please contact the study team at peggy.alton@duke.edu.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:
- Have a physical exam
- Have a heart scan (ECG)
- Have blood draws
- Have bone marrow samples taken
- Have imaging (X-ray, CT scan or PET/CT)
If you are eligible to continue in the study after screening, you will:
- Check into the hospital for at least 8 days to begin the study therapy
- Get an infusion (through IV) of Kymriah the day after you check in
- Check into the hospital again for about 24 hours approximately 3 weeks after receiving Kymriah
- Get an injection (shot) of the study drug when you check in for this second admission
When you are not staying in the hospital, you will need to stay within a 1-hour drive of Duke during the time between the two hospital admissions and for 4 weeks after the second hospital admission.
We will schedule you to come in for 3 follow-up visits after your study drug injection to see how you are doing.
- Have a physical exam
- Have a heart scan (ECG)
- Have blood draws
- Have bone marrow samples taken
- Have imaging (X-ray, CT scan or PET/CT)
If you are eligible to continue in the study after screening, you will:
- Check into the hospital for at least 8 days to begin the study therapy
- Get an infusion (through IV) of Kymriah the day after you check in
- Check into the hospital again for about 24 hours approximately 3 weeks after receiving Kymriah
- Get an injection (shot) of the study drug when you check in for this second admission
When you are not staying in the hospital, you will need to stay within a 1-hour drive of Duke during the time between the two hospital admissions and for 4 weeks after the second hospital admission.
We will schedule you to come in for 3 follow-up visits after your study drug injection to see how you are doing.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 1b Study Evaluating the Safety, Tolerability and Preliminary Anti-tumor Activity of NT-I7 (efineptakin alfa) a Long-acting Human IL-7, post-Tisagenlecleucel (Kymriah®) in Subjects with Relapsed/Refractory Large B-cell Lymphoma
Principal Investigator
Ahmed
Galal
Protocol Number
PRO00108034
NCT ID
NCT05075603
Phase
I
Enrollment Status
OPEN TO ACCRUAL