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OncoMatch/Clinical Trials/NCT04554914

A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases

Is NCT04554914 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tabelecleucel for epstein-barr virus (ebv)-associated diseases.

Phase 2RecruitingPierre Fabre MedicamentNCT04554914Data as of May 2026

Treatment: TabelecleucelThe purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with EBV-associated diseases.

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Extracted eligibility criteria

Cancer type

Sarcoma

Biomarker criteria

Required: EBV positive

Diagnosis of EBV+ disease

Performance status

ECOG/LANSKY 0–3

Eastern Cooperative Oncology Group performance status ≤ 3 for participants aged ≥ 16 years; Lansky score ≥ 20 for participants from ≥ 1 year to < 16 years.

Prior therapy

Cannot have received: investigational product

Within 4 weeks or 5 half-lives (whichever is shorter) for any investigational product

Cannot have received: chemotherapy

Within 4 weeks or 5 half-lives (whichever is shorter) for any...chemotherapy (systemic or intrathecal)

Cannot have received: targeted small molecule therapy

Within 4 weeks or 5 half-lives (whichever is shorter) for any...targeted small molecule therapy

Cannot have received: antibody/biologic therapy

Exception: prior anti-CD20 antibody use is permitted within the washout period if a subsequent disease response assessment indicates disease progression

Within 4 weeks or 5 half-lives (whichever is shorter) for any...antibody/biologic therapy

Cannot have received: cellular therapies (CAR-T, donor lymphocyte infusion, other CTLs or virus-specific T-cells)

Within 8 weeks: prior tabelecleucel (> 8 weeks prior to enrollment) is permitted if response was obtained or if usual protocol-directed therapeutic options were not exhausted, for cellular therapies (chimeric antigen receptor therapies directed at T-cells or T-cell subsets, donor lymphocyte infusion, other CTLs or virus-specific T-cells); and/or therapies which could impact tabelecleucel function (anti-thymocyte globulin, alemtuzumab)

Cannot have received: anti-thymocyte globulin

therapies which could impact tabelecleucel function (anti-thymocyte globulin, alemtuzumab)

Cannot have received: alemtuzumab

therapies which could impact tabelecleucel function (anti-thymocyte globulin, alemtuzumab)

Cannot have received: EBV-CTLs

Exception: tabelecleucel as above

Any prior treatment with EBV-CTLs with the exception of tabelecleucel as above

Lab requirements

Blood counts

Adequate organ function test results, unless organ dysfunction is considered to be due to the underlying EBV-associated disease by the investigator.

Kidney function

Adequate organ function test results, unless organ dysfunction is considered to be due to the underlying EBV-associated disease by the investigator.

Liver function

Adequate organ function test results, unless organ dysfunction is considered to be due to the underlying EBV-associated disease by the investigator.

Adequate organ function test results, unless organ dysfunction is considered to be due to the underlying EBV-associated disease by the investigator.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of California Los Angeles (UCLA) (Adults and Pediatrics) · Los Angeles, California
  • Children's Hospital of Orange County (Pediatrics [up to 25 years old]) · Orange, California
  • Lucile Packard Children's Hospital Stanford (Pediatrics only) · Palo Alto, California
  • University of California Davis Comprehensive Cancer Center (Adults and Pediatrics) · Sacramento, California
  • Sylvester Comprehensive Cancer Center/ University of Miami · Miami, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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