Neoimmunetech_NT-I7_Ph1b_R/R_LBCL (Large B Cell Lymphoma) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Large B-cell Lymphoma (LBL)

Who Can Participate in the Study?

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 surya.nagesh@duke.edu.

Age Group
Adults

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.

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
Cellular Therapy Specialist
Protocol Number
IRB: PRO00108034
NCT: NCT05075603
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698