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

NCT05075603 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-10-23

No results posted yet for this study

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

Interventions

DRUG

Efineptakin alfa

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

DRUG

Tisagenlecleucel

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

DRUG

Axicabtagene ciloleucel

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

DRUG

Lisocabtagene Maraleucel

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

Sponsors & Collaborators

  • NeoImmuneTech

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-06
Primary Completion
2024-12-18
Completion
2025-03-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05075603 on ClinicalTrials.gov