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

NCT05075603 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: NIT-112
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

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 CAR T-cell therapy for eligible subjects with r/r LBCL.

Conditions

Refractory Diffuse Large B-cell Lymphoma; Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified; Recurrent Diffuse Large B-Cell Lymphoma; Refractory High Grade B-Cell Lymphoma; Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (4)

• For Dose Escalation Phase: Incidence of adverse events (AE)

  According to NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  21 Days

• Incidence of Dose Limiting Toxicities (DLT)

  DLT is defined as any AE occurring within the first 21 days after NT-I7 injection that is considered to be at least possibly, probably, or definitely related to the study treatment (NT-I7) per the investigator, and that meets at least one of the non-hematologic or hematologic criteria listed below.

  21 Days

• To determine the Maximum Tolerated Dose (MTD)

  The MTD will be defined as the dose of NT-I7 that yields a DLT rate ≤ 33%.

  21 Days

• To determine the Recommended Phase 2 Dose (RP2D)

  Determination of the RP2D: The RP2D will be based on an accumulation of all available data. All available data including clinical Pharmacokinetic, Pharmacodynamic, anti-tumor activity (including best overall response rate) and safety, and nonclinical pharmacology data will be pooled. Integrated dose-response and exposure-response analyses will be conducted to determine the RP2D

  21 Days

Secondary Outcomes (7)

• Measurement of Duration of Response (DOR)

  up to 3 months

• Measurement of Progression-Free Survival (PFS)

  up to 3 months

• Measurement of Overall Survival (OS)

  up to 3 months

• Rates of grade 3 and higher cytokine release syndrome (CRS)

  Up to 3 months

• Rates of grade 3 and higher immune effector cell associated neurotoxicity syndrome (ICANS)

  Up to 3 months

Study Arms (1)

NT-I7 after CAR-T (Kymriah, Yescarta, or Breyanzi) infusion

EXPERIMENTAL

CAR-T infusion administered per standard of care at Day 0 followed by NT-I7 on Day 21.

Drug: Efineptakin alfa; Drug: Tisagenlecleucel; Drug: Axicabtagene ciloleucel; Drug: Lisocabtagene Maraleucel

Interventions

Efineptakin alfa DRUG

NT-I7 is administered via an intramuscular injection after CAR-T infusion on Day 21.

Also known as: NT-I7, rhIL-7-hyFc

NT-I7 after CAR-T (Kymriah, Yescarta, or Breyanzi) infusion

Tisagenlecleucel DRUG

Administered as standard of care as described in the package insert on Day 0.

Also known as: Kymriah

NT-I7 after CAR-T (Kymriah, Yescarta, or Breyanzi) infusion

Axicabtagene ciloleucel DRUG

Administered as standard of care as described in the package insert on Day 0.

Also known as: Yescarta

NT-I7 after CAR-T (Kymriah, Yescarta, or Breyanzi) infusion

Lisocabtagene Maraleucel DRUG

Administered as standard of care as described in the package insert on Day 0.

Also known as: Breyanzi

NT-I7 after CAR-T (Kymriah, Yescarta, or Breyanzi) infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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
• 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 (eg, by local surgery or radiotherapy) of isolated lesions for palliative intent is acceptable beyond the 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 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.

Sponsors & Collaborators

• NeoImmuneTech: lead

Study Sites (4)

City of Hope

Duarte, California, 91010, United States

Location

Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

efineptakin alfa; tisagenlecleucel; axicabtagene ciloleucel

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

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: August 6, 2021
• Primary Completion: December 18, 2024
• Study Completion: March 12, 2025
• Last Updated: October 23, 2025

Record last verified: 2025-10

Locations

US (4)