NT-I7 + CAR T-Cell Therapy for Large B-Cell Lymphoma
Trial Summary
What is the purpose of this trial?
This is a multicenter Phase 1b study evaluating the safety, tolerability, and preliminary anti-tumor activity of NT-I7 administration following standard of care CD19 CAR T-cell therapy for eligible subjects with r/r LBCL.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot have any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment. Non-cancer-related medications, like insulin for diabetes, are allowed.
What data supports the effectiveness of the treatment NT-I7 + CAR T-Cell Therapy for Large B-Cell Lymphoma?
Research shows that a long-acting form of interleukin-7 (IL-7), called rhIL-7-hyFc, can improve the effectiveness of CAR T-cell therapy by helping these cells grow, last longer, and fight cancer better in animal models. This suggests that using rhIL-7-hyFc with CAR T-cell therapy might help treat large B-cell lymphoma more effectively.12345
Is NT-I7 (Efineptakin alfa) safe for human use?
NT-I7 (Efineptakin alfa) has been tested in humans and is generally well-tolerated. In studies, the most common side effect was a reaction at the injection site, which resolved on its own. It has been used safely in healthy volunteers and patients with conditions like HIV and glioblastoma, showing potential as a treatment option for those with low T-cell counts.12367
How is NT-I7 + CAR T-Cell Therapy different from other treatments for Large B-Cell Lymphoma?
This treatment combines CAR T-cell therapy, which uses modified immune cells to target cancer, with NT-I7, a long-acting form of interleukin-7 (a protein that boosts immune cell growth). NT-I7 enhances the expansion and persistence of CAR T-cells, potentially improving their effectiveness against tumors compared to standard CAR T-cell therapies.12368
Eligibility Criteria
Adults over 18 with relapsed/refractory Large B-cell Lymphoma who've had at least two prior treatments and are eligible for CD19 CAR T-cell therapy. They must have an ECOG performance status of 0-1, measurable disease, a life expectancy of 12+ weeks, and adequate organ function. Exclusions include severe reactions to previous CAR T-cell therapy, pregnancy, CNS lymphoma involvement, active infections or concurrent clinical study participation.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Subjects are enrolled in 1 of 7 dose levels to determine the maximum tolerated dose of NT-I7
Dose Expansion
Up to 15 subjects are treated with the recommended dose identified in the Dose Escalation phase
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- NT-I7
Find a Clinic Near You
Who Is Running the Clinical Trial?
NeoImmuneTech
Lead Sponsor