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NCT05075603 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by NeoImmuneTech.

Completed
Registry status
Phase 1
Development phase
17
Enrollment target

NCT05075603: Completed Phase 1 study, sponsored by NeoImmuneTech.

NCT05075603 is a Phase 1 study that has completed, run by NeoImmuneTech. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05075603, a Phase 1 study, has completed, sponsored by NeoImmuneTech.

COMPLETED
Registry status
Phase 1
Development phase
17 participants
Enrollment target

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.

Primary Outcome

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 congenit

Interventions

  • DRUG Tisagenlecleucel
  • DRUG Efineptakin alfa
  • DRUG Axicabtagene ciloleucel
  • DRUG Lisocabtagene Maraleucel

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2021-08-06
Est. Completion 2025-03-12
Phase Phase 1
NeoImmuneTech

6 total trials

What the finished NCT05075603 record still lists

NCT05075603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 4 interventions - of which Tisagenlecleucel is the first listed.

NCT05075603 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05075603 about?

NCT05075603 is a clinical study titled "Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy". 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.

What is the current status of trial NCT05075603?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2021-08-06. Estimated completion is 2025-03-12.

What interventions are being tested in trial NCT05075603?

The interventions under investigation include: Tisagenlecleucel (DRUG), Efineptakin alfa (DRUG), Axicabtagene ciloleucel (DRUG), Lisocabtagene Maraleucel (DRUG).

Who is sponsoring clinical trial NCT05075603?

This trial is sponsored by NeoImmuneTech, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05075603's enrollment target sits among peer trials

17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05075603, the US trial registry maintained by the National Library of Medicine. NCT05075603 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.