CompletedPhase 1/2

T Lymphocytes for the Treatment of AdV, CMV, EBV, BKV and Aspergillus Fumigatus Infections After Allogeneic Stem Cell Transplantation

Greece10 participantsStarted 2021-05-22

Plain-language summary

The purpose of the study is to determine the feasibility, safety and efficacy of administering rapidly-generated donor-derived pentavalent-specific T cells (Penta-STs) to mediate antiviral and antifungal activity in hematopoietic stem cell transplant (HSCT) recipients with AdV, EBV, CMV, BKV or Aspergillus fumigatus (AF) infection/ reactivation or with active disease.

Who can participate

Age range18 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Received prior myeoloablative or nonmyeloablative allogeneic hematopoietic stem cell transplant.
✓. Cells administered as treatment for single or multiple infections/reactivations of one or more of the following pathogens: AdV, CMV, EBV, ΒΚV and AF.
✓. Karnofsky/Lansky score of ≥ 50.
✓. ANC \> 500/μl.
✓. Bilirubin ≤ 2x\*, AST \< 3x\*, Serum creatinine ≤ 2x\*, Hemoglobin \> 8.0 g/dl.
✓. Pulse oximetry of \> 90% on room air.
✓. Available pentavalent-specific T cells.
✓. Negative pregnancy test (if female of childbearing potential)

Exclusion criteria

✕. Received ATG, or Campath or other T cell immunosuppressive monoclonal antibodies in the last 28 days.
✕. Steroids \> 0.5 mg/kg/day prednisone.
✕. Received donor lymphocyte infusion in last 28 days.
✕. GVHD ≥ grade 2.
✕. Active and uncontrolled relapse of malignancy.
✕. Patients with other uncontrolled infections

What they're measuring

Acute GvHD

Timeframe: Within 6 weeks post the last dose of penta-STs

Chronic GvHD

Timeframe: Within 6 months post the last dose of penta-STs

Infusion-related adverse events

Timeframe: Within 30 days of the last dose of penta-STs

Non hematological, adverse events

Timeframe: Within 30 days of the last dose of penta-STs

Resolution of infection - 1

Timeframe: 12 weeks post the last dose of penta-STs

Resolution of infection - 2

Timeframe: 12 weeks post the last dose of penta-STs

Antiviral immunity

Timeframe: 12 weeks post the last dose of penta-STs

Antifungal immunity

Timeframe: 12 weeks post the last dose of penta-STs

Trial details

NCT IDNCT05471661

SponsorGeorge Papanicolaou Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-05

View on ClinicalTrials.gov More Opportunistic Fungal Infection trials

Plain-language summary

Who can participate

Age range18 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Received prior myeoloablative or nonmyeloablative allogeneic hematopoietic stem cell transplant.
✓. Cells administered as treatment for single or multiple infections/reactivations of one or more of the following pathogens: AdV, CMV, EBV, ΒΚV and AF.
✓. Karnofsky/Lansky score of ≥ 50.
✓. ANC \> 500/μl.
✓. Bilirubin ≤ 2x\*, AST \< 3x\*, Serum creatinine ≤ 2x\*, Hemoglobin \> 8.0 g/dl.
✓. Pulse oximetry of \> 90% on room air.
✓. Available pentavalent-specific T cells.
✓. Negative pregnancy test (if female of childbearing potential)

Exclusion criteria

✕. Received ATG, or Campath or other T cell immunosuppressive monoclonal antibodies in the last 28 days.
✕. Steroids \> 0.5 mg/kg/day prednisone.
✕. Received donor lymphocyte infusion in last 28 days.
✕. GVHD ≥ grade 2.
✕. Active and uncontrolled relapse of malignancy.
✕. Patients with other uncontrolled infections

What they're measuring

Acute GvHD

Timeframe: Within 6 weeks post the last dose of penta-STs

Chronic GvHD

Timeframe: Within 6 months post the last dose of penta-STs

Infusion-related adverse events

Timeframe: Within 30 days of the last dose of penta-STs

Non hematological, adverse events

Timeframe: Within 30 days of the last dose of penta-STs

Resolution of infection - 1

Timeframe: 12 weeks post the last dose of penta-STs

Resolution of infection - 2

Timeframe: 12 weeks post the last dose of penta-STs

Antiviral immunity

Timeframe: 12 weeks post the last dose of penta-STs

Antifungal immunity

Timeframe: 12 weeks post the last dose of penta-STs