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.
Treatment: Tabelecleucel — The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with EBV-associated diseases.
Check if I qualifyExtracted 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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