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Phase 3RecruitingPriority 1 · Highest priorityNCT03394365

A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy

ClinicalTrials.gov

Plain-language summary

This Phase 3 trial is comparing different first-line treatment approaches for people newly diagnosed with NK/T-cell lymphoma. Patients are randomly assigned to different treatment groups to see which approach works best. It is widely available at 40 US locations.

Who can join (key eligibility)

  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

tabelecleucel (BIOLOGICAL): Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.

Drugs / treatments
tabelecleucel
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details
TrialCompass — Clinical Trial Summary

A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy

NCT03394365

Phase: Phase 3 | Status: Recruiting | Priority: Highest

Plain-language summary

This Phase 3 trial is comparing different first-line treatment approaches for people newly diagnosed with NK/T-cell lymphoma. Patients are randomly assigned to different treatment groups to see which approach works best. It is widely available at 40 US locations.

Who can join

  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

What's being tested

tabelecleucel (BIOLOGICAL): Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.

Drugs / treatments: tabelecleucel

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 115 patients

Primary endpoint: Objective Response Rate (ORR) in the Analysis Cohorts C-SOT, C-HCT, and Combined Population (C-SOT-R+C, C-SOT-R-Ci, and C-HCT) Who Received Commercial Product, or a Product Manufactured Using a Comparable PV

Ages: — to —

Start date: 2017-12-29 | Est. completion: 2030-08

Locations

40 US sites · 71 total

California, Connecticut, District of Columbia, Florida, Georgia, Illinois, Maryland, Massachusetts, Missouri, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Wisconsin

Contact

Anke Friedetzky | ATA129-EBV-302_medical.team@pierre-fabre.com | (000) 000-0000

Sponsor: Pierre Fabre Medicament (INDUSTRY)

Tags

ENKTL · Maintenance · Newly diagnosed

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT03394365

Prepared using TrialCompass (trialcompass.com) on July 4, 2026. For informational purposes only. Always discuss with your healthcare team.