Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cell Medica Ltd
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. The study will include three primary cohorts, with any of the following EBV+ diseases:
You may not be if
Cohort B - HL, brentuximab vedotin (BV) treatment failure or unable to tolerate BV.
Cohort C - PTLD, rituximab treatment failure.
2. Presence of active lymphoma or active PTLD, based on imaging performed within the previous 3 months.
3. Tumor positive for EBV encoded RNA (EBER) based on report from certified laboratory.
4. Absolute lymphocyte count (ALC) \>500/µL
5. Male or female ≥ 12 years of age
6. Weight ≥ 35 kg
7. Eastern Cooperative Oncology Group (ECOG) performance score 0-2, inclusively or Lansky score ≥ 60, as age appropriate
8. Able to understand and comply with the requirements of the study and to provide written informed consent or age appropriate assent for pediatric patients.
1. Known central nervous system (CNS) lymphoma
2. Primary refractory HL or DLBCL
3. Bulky disease
4. Relapse or progression following previous autologous EBV specific T cell treatment.
5. Use of systemic corticosteroids \> 0.5 mg/kg/day prednisolone or equivalent does of alternative corticosteroid within 10 days prior to obtaining 200 mL starting material
6. Positive for HIV, hepatitis B, hepatitis C, syphilis or human T cell leukemia virus (HTLV).
7. Patient is pregnant or lactating
8. Systemic fungal, bacterial, viral or other infection that is not controlled
