Using EBV-specific T cells to treat EBV-positive lymphomas
Constitutive IL7 (C7R) Modified EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma
This study is testing if specially modified T cells that target the Epstein-Barr virus can help people with certain types of lymphoma that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Drugs / interventions | chemotherapy, prednisone, cyclophosphamide, fludarabine |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT04664179 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on patients with EBV-positive Hodgkin and non-Hodgkin lymphoma, as well as T/NK-lymphoproliferative diseases that have not responded to previous treatments. Participants will donate blood to create genetically modified T cells that target the Epstein-Barr virus (EBV) present in their cancer cells. The trial involves administering these modified T cells, potentially alongside standard chemotherapy, to evaluate their effectiveness and monitor for long-term side effects over a period of 15 years.
Who should consider this trial
Good fit: Ideal candidates include individuals of any age or sex with EBV-positive Hodgkin's or non-Hodgkin's lymphoma, or EBV-associated T/NK-lymphoproliferative disease.
Not a fit: Patients with EBV-negative lymphomas or those who are not eligible for immunosuppressive chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel and effective option for patients with EBV-positive lymphomas that are resistant to conventional therapies.
How similar studies have performed: Other studies utilizing T-cell therapies targeting viral antigens have shown promising results, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
1. INCLUSION CRITERIA AT TIME OF PROCUREMENT 1. Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non Hodgkin's Lymphoma, (regardless of the histological subtype) or EBV (associated)- T/NK-lymphoproliferative disease who may subsequently be eligible for the treatment component 2. EBV positive tumor (can be pending) 3. Weighs at least 10 kg 4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given a copy of informed consent. 2. INCLUSION CRITERIA AT TIME OF INFUSION 1\) Any patient regardless of age or sex, with diagnosis of either 1. EBV positive Hodgkin's lymphoma 2. EBV positive non-Hodgkin's Lymphoma (regardless of histologic subtype) 3. EBV (associated)-T/NK-lymphoproliferative disease AND either A) In first or subsequent relapse or with persistent active disease despite therapy; OR B) With active disease if immunosuppressive chemotherapy is contraindicated as determined by the study PI, in consultation with the primary provider as needed, e.g. patients who develop Hodgkin's disease after solid organ transplantation or if the lymphoma is a second malignancy, e.g. a Richter's transformation of CLL. 2\) EBV positive tumor confirmed by pathology 3\) Patients with life expectancy ≥ 6 weeks 4\) Patients with bilirubin ≤ 3x upper limit of normal, AST ≤ 3x upper limit of normal, creatinine ≤ 2x upper limit of normal for age and Hgb ≥ 7.0 (may be a transfused value) 5\) Pulse oximetry of \>90% on room air 6\) Patients should have been off other investigational therapy for 4 weeks prior to entry in this study. 7\) Patients with a Karnofsky/Lansky score of ≥ 50 8\) Informed consent explained to, understood and signed by patient/guardian. Patient/guardian given a copy of informed consent. 3. EXCLUSION CRITERIA AT TIME OF PROCUREMENT 1\. Known pregnancy or actively breastfeeding (pregnancy test is not required at the time of procurement). 4. EXCLUSION CRITERIA AT TIME OF INFUSION 1. Pregnant or breastfeeding 2. Active and uncontrolled bacterial, viral or fungal infection 3. Current use of systemic corticosteroids (prednisone equivalent \>0.5 mg/kg/day) 4. Bulky disease resulting in airway obstruction or risk for airway obstruction with further enlargement.
Where this trial is running
Houston, Texas and 1 other locations
- Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
- Texas Children's Hospital — Houston, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Bilal Omer, MD — Baylor College of Medicine
- Study coordinator: Bilal Omer, MD
- Email: bomer@bcm.edu
- Phone: 832-824-6855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.