Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy

Eligibility Criteria

• 1. In Dose Escalation phase: Grade ≥3 CRS or ICANS post-CD19 CAR T-cell infusion. Note: Grade 1 or 2 CRS or ICANs must be completely resolved \>3 days prior to NT-I7 injection
• 2. In Dose Expansion phase: Grade ≥3 CRS or ICANS post-CD19 CAR T-cell infusion. Note: Grade 1 or 2 CRS or ICANS must be completely resolved \>3 days prior to NT-I7 injection
• 3. Pregnant, lactating or breastfeeding or expecting to conceive or father children within the study duration from screening through 120 days after the last dose of study treatment.
• 4. This exclusion criteria has been removed and remains as a placeholder.
• 5. Subjects with documented current central nervous system (CNS) involvement by lymphoma are to be excluded from study participation.
• 6. Any concurrent chemotherapy or biologic or hormonal therapy for cancer treatment.
• 7. Subjects who have autoimmune disease history for the past 2 years, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. The following are exceptions to this criterion:
• 1. Subjects with vitiligo or alopecia.
• 2. Subjects with type 1 diabetes mellitus.
• 3. Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
• 4. Psoriasis not requiring systemic treatment.
• 5. NOTE: Diverticulitis that is not associated with inflammatory bowel disease is not considered exclusionary (e.g., subjects who do not have active diarrhea due to chronic diverticulitis).
• 8. Have active and clinically relevant bacterial, fungal, viral, or TB infection, including known Hepatitis A, B, or C or HIV (testing not required).
• 9. Concurrent enrollment in another clinical study unless it is an observational (noninterventional) clinical study.
• 10. Receipt of any conventional or investigational anticancer therapy, not otherwise specified above, within 30 days prior to NT-I7 injection.
• 11. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade ≤ 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (e.g., hearing loss, peripheral neuropathy) after consultation with the medical monitor.
• 12. Receipt of live, attenuated vaccine within 30 days prior to NT-I7 injection. Note: Subjects, if enrolled, should not receive live vaccine during the study and through 30 days after NT-I7 injection, whichever is longer. The administration of killed vaccines is permitted at any time.
• 13. Has had an allogenic tissue/solid organ transplant or bone marrow transplant.
• 14. Subjects for whom intramuscular therapy is contraindicated.
• 15. Has clinically significant cardiac disease, including, but not limited to, any of the following:
• 1. Uncontrolled atrial fibrillation
• 2. Congestive Heart Failure NYHA Class ≥ 2
• 3. Or any of the following within 6 months prior to Baseline, Day 0 CAR-T administration:
• * Unstable angina
• * Myocardial infarction
• * Coronary artery bypass grafting
• * Coronary angioplasty
• * Coronary stenting
• * Clinically significant cardiac arrhythmia and/or conduction abnormality
• 4. History of other clinically significant cardiac disease that, in the opinion of the Investigator or designee, is a contraindication to study treatment is also excluded.