Viral Specific T-Lymphocytes to Treat Infection With Adenovirus, Cytomegalovirus or Epstei
The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥2/6 HLA-matched, viral specific T cells have efficacy against adenovirus, CMV, and EBV, in subjects who have previously received any type of allogeneic HCT or solid organ transplant (SOT), or have compromised immunity. Reconstitutio
| Condition(s) | Adenovirus, Cytomegalovirus Infections, Epstein-Barr Virus Infections |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥2/6 HLA-matched, viral specific T cells have efficacy against adenovirus, CMV, and EBV, in subjects who have previously received any type of allogeneic HCT or solid organ transplant (SOT), or have compromised immunity. Reconstitution of anti-viral immunity by donor-derived cytotoxic T lymphocytes has shown promise in preventing and treating infections with adenovirus, CMV, and EBV. However, the weeks taken to prepare patient-specific products, and cost associated with products that may not be used limits their value. In this trial, we will evaluate viral specific T cells generated by gamma capture technology. Eligible patients will include HCT and/or SOT recipients, and/or patients with compromised immu |
| Who can participate | Patient Inclusion Criteria 1. Patient, parent, or legal guardian must have given written informed consent, according to FDA guidelines. For patients ≥ 7 years of age who are developmentally able, assent or affirmation will be obtained, if feasible. 2. Male or female, 1 month through 65 years old, inclusive, at the time of informed consent. 3. Prior allogeneic hematopoietic stem cell transplant, AND/OR prior solid organ transplant (liver, kidney, lung and/or heart, intestinal, pancreatic, and/or multivisceral), AND/OR diagnosis of primary immunodeficiency AND/OR current/recent administration of immunosuppressive therapy for cancer or autoimmune disease. 4. If receiving steroids, must be able to taper dose to less than 1 mg/kg/day prednisone (or equivalent) prior to cellular infusion. 5. Neg |
| Ages | 1 Month to 65 Years |
| Sex | All |
| Lead sponsor | Jessie L. Alexander |
| Locations | Palo Alto, California, United States; Palo Alto, California, United States; Palo Alto, California, United States |
| Start date | 2025-04-30 |
| NCT ID | NCT06909110 |
| Official listing | https://clinicaltrials.gov/study/NCT06909110 |