Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy
A Phase 1b Study Evaluating the Safety, Tolerability and Preliminary Anti-tumor Activity of NT-I7 a Long-acting Human IL-7, Post-Kymriah®, Post-Yescarta®, or Post-Breyanzi® in Subjects With Relapsed/Refractory Large B-cell Lymphoma
1 other identifier
interventional
17
1 country
3
Brief Summary
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 chimeric antigen receptor T-cell (CAR T-cell) therapy for eligible subjects with relapsed/refractory (r/r) large B-cell lymphoma (LBCL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2021
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 29, 2021
CompletedFirst Submitted
Initial submission to the registry
September 13, 2021
CompletedFirst Posted
Study publicly available on registry
October 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2025
CompletedResults Posted
Study results publicly available
August 10, 2026
CompletedAugust 10, 2026
August 1, 2026
3.4 years
September 13, 2021
May 6, 2026
August 6, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines
Treatment-Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) with an onset date on or after NT-I7 administration and on or before Day 100. A serious TEAE is defined as any AE that resulted in any of the following outcomes: death; a life-threatening AE; an AE that resulted in inpatient hospitalization or prolongation of existing hospitalization for ≥24 hours; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect; important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
From NT-I7 administration (Day 21) to Day 100
Incidence and Nature of DLTs
A Dose-Limiting Toxicity (DLT) is defined as any TEAE occurring within the first 21 days after NT-I7 administration that is considered to be at least possibly, probably, or definitely related to NT-I7 per the investigator, and that meets at least one of the protocol-defined non-hematologic or hematologic criteria.
From NT-I7 administration (Day 21) to Day 42
Potential Correlation of Dose Levels With Safety and Efficacy Parameters
The Recommended Phase 2 Dose (RP2D) was determined based on cumulative safety data and efficacy parameters (Objective Response Rate \[ORR\] and response rate at 6 months).
Up to 24 months
Secondary Outcomes (4)
Measurement of Duration of Response (DoR)
Up to 24 months
Measurement of Progression-Free Survival (PFS)
Up to 24 months
Measurement of Overall Survival (OS)
Up to 24 months
Rates of Grade 3 and Higher Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
From NT-I7 administration (Day 21) to Day 100
Study Arms (1)
NT-I7 after CAR-T (Kymriah, Yescarta, or Breyanzi) infusion
EXPERIMENTALCAR-T infusion administered per standard of care at Day 0 followed by NT-I7 on Day 21.
Interventions
NT-I7 is administered via an intramuscular injection after CAR-T infusion on Day 21.
Administered as standard of care as described in the package insert on Day 0.
Administered as standard of care as described in the package insert on Day 0.
Administered as standard of care as described in the package insert on Day 0.
Eligibility Criteria
You may not qualify if:
- Subjects meeting any of the following criteria are not eligible for enrollment in the study:
- In Dose Escalation phase: Grade ≥3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (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
- 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
- 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.
- Subjects with documented current central nervous system (CNS) involvement by lymphoma are to be excluded from study participation.
- Any concurrent chemotherapy or biologic or hormonal therapy for cancer treatment.
- Note: Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable. In addition, local treatment (e.g., by local surgery or radiotherapy) of isolated lesions for palliative intent is acceptable beyond the dose-limiting toxicity (DLT) evaluation period with prior consultation and agreement with the medical monitor.
- 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:
- Subjects with vitiligo or alopecia.
- Subjects with type 1 diabetes mellitus.
- Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Psoriasis not requiring systemic treatment.
- Have active and clinically relevant bacterial, fungal, viral, or TB infection, including known Hepatitis A, B, or C or human immunodeficiency virus (HIV) (testing not required).
- Concurrent enrollment in another clinical study unless it is an observational (noninterventional) clinical study.
- Receipt of any conventional or investigational anticancer therapy, not otherwise specified above, within 30 days prior to NT-I7 injection.
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NeoImmuneTechlead
Study Sites (3)
City of Hope
Duarte, California, 91010, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Duke Cancer Institute
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gloria Bae, Clinical Project Coordinator
- Organization
- NeoImmuneTech, Inc
Study Officials
- PRINCIPAL INVESTIGATOR
John DiPersio, M.D.
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2021
First Posted
October 13, 2021
Study Start
July 29, 2021
Primary Completion
December 18, 2024
Study Completion
March 12, 2025
Last Updated
August 10, 2026
Results First Posted
August 10, 2026
Record last verified: 2026-08