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

Part of paid clinical trials in Duarte, California.

Sponsor
NeoImmuneTech
Study ID
NCT05075603
Phase
PHASE1
Status
Completed

Conditions

  • DLBCL Arising From Follicular Lymphoma
  • High-grade B-cell Lymphoma
  • Primary Mediastinal Large B-cell Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Refractory Diffuse Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Efineptakin alfa — DRUG
    NT-I7 is administered via an intramuscular injection after CAR-T infusion on Day 21.
  • Tisagenlecleucel — DRUG
    Administered as standard of care as described in the package insert on Day 0.
  • Axicabtagene ciloleucel — DRUG
    Administered as standard of care as described in the package insert on Day 0.
  • Lisocabtagene Maraleucel — DRUG
    Administered as standard of care as described in the package insert on Day 0.

Study Details

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).

Key Dates

First listed
Oct 13, 2021
Start date
Jul 29, 2021
Status verified
Aug 2026
Primary completion
Dec 18, 2024
Completion
Mar 12, 2025

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NT-I7 after CAR-T (Kymriah, Yescarta, or Breyanzi) infusion
    CAR-T infusion administered per standard of care at Day 0 followed by NT-I7 on Day 21.

Primary Outcome Measure

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 [ Time Frame: From NT-I7 administration (Day 21) to Day 100 ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Washington University in St. LouisSt LouisMissouri63110-
Duke Cancer InstituteDurhamNorth Carolina27710-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAWashington University in St. Louis· St Louis, MODuke Cancer Institute· Durham, NC

Related Studies