Clinical trial · Interventional
Using Multi-virus Cytotoxic T-cells Following T-Cell Depleted Allogeneic HPCT for Prophylaxis Against EBV, ADV, and CMV
A Phase I Study Of Using Multi-virus Cytotoxic T-cells Following T-cell Depleted Allogeneic Hematopoietic Progenitor Cell Transplantation For Prophylaxis Against Specific Pathogens- Epstein Barr Virus, Adenovirus, And Cytomegalovirus (ACE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This protocol is a phase I study. Patients may be eligible for an infusion of Multi-virus Cytotoxic T Lymphocytes (CTL) if they received a T-cell depleted (TCD) transplant from a related family member or an unrelated donor. Recipients of these types of transplants are severely immune compromised during the early post-transplant period and are more susceptible to certain viruses. The investigators hypothesize that the adoptive transfer of Cytotoxic T Lymphocytes (CTL) against certain viruses: Adenovirus, Cytomegalovirus and Epstein Barr Virus (Ad, CMV, and EBV) will be safe with regard to producing graft versus host disease (GVHD) or other infusion related toxicities.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenovirus | — | UNRESOLVED | — |
| Cytomegalovirus Infections | — | UNRESOLVED | — |
| Epstein-Barr Virus Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytotoxic T Lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multi-Virus CTLs
- description
- The treatment plan delivers a single dose of Multi-Virus CTL to all patients enrolled on study.
- interventionNames
- Biological: Cytotoxic T Lymphocytes
Primary outcomes (1)
- measure
- To assess toxicity by SAEs scored according to the adaptive CTCAE version 5
- timeFrame
- 1 year
- description
- Phase/safety/toxicity
Secondary outcomes (2)
- measure
- Evidence of immunity against specific viral pathogens- Ad, CMV and EBV in recipients of Multi-Virus CTLs
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: * Patient age \< 22 years. * Both genders and all races are eligible. * The patient population chosen for the T-cell depleted allogeneic HPCT from a related or unrelated allogeneic donor must meet eligibility based on institutional SOPs and/or the IRB approved T cell depleted allogeneic HPCT protocol which they are enrolled. * Must be willing to sign a written informed consent. * Patient Organ Status at the time of enrollment (pre-transplant) * Lansky or Karnofsky score \> 50 * Echocardiogram shortening fraction \> 27% * Renal function: serum creatinine \< 2 x normal for age * DLCO \> 50% predicted in patients old enough to comply with PFTs or no baseline oxygen requirement for younger patients. * Hepatic: AST, ALT \< 5x upper limit of normal; bilirubin \< 2.0 mg/dl * Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months following CTL infusion. The male partner should use a condom. * Patients must be between 28 and 100 days post T-cell depleted allogeneic HPCT * Patients must meet the following criteria (within 72 hours of CTL infusion): * Achieved primary engraftment with an ANC of at least 1000 per μl for 3 consecutive days. * No oxygen requirement with oxygen saturations \> 90%. * AST, ALT \< 5x upper limit of normal for age; bilirubin \< 2 mg/dl. * Hemoglobin \> 8 gm/dl prior to infusion. (May be transfusion dependent). * Renal function: serum creatinine \< 2 x normal for age. * The Patient must not have the following conditions on the day of CTL infusion: * Exhibit overt hematologic manifestations of relapse or persistent disease. * Evidence of recurrent/persistent disease based primarily on flow cytometry, cytogenetics, chimerism analysis, or other molecular studies does not by itself represent grounds for exclusion. Exclusion Criteria: * Currently enrolled on another Phase I clinical trial. * Pregnant or nursing * Overt hematologic manifestations of relapse or persistent disease * Having \> grade 1 graft-versus-host disease.
References
Publications (0)
Data not yet available