TerminatedPhase 1

Treatment of Cytomegalovirus (CMV) Infections With Viral-Specific T Cells

Stopped: Slow accrual

United States3 participantsStarted 2020-02-06

Plain-language summary

The present trial will consist of the treatment of 20 pediatric and adult Hematopoietic Stem Cell Transplantation (HSCT) recipients or immunocompromised participants diagnosed with opportunistic Cytomegalovirus (CMV) infections with virus-specific, antigen-selected T-cells. CMV-specific T-cells will be isolated from donor leukapheresis products using the CliniMACS® Prodigy. Prior studies on transfer of CMV specific T-cells have been shown to be safe and efficacious in the treatment of CMV infections. The main trial objective is to evaluate the feasibility and safety of CMV-specific T-cell transfer in adult and pediatric participants suffering from CMV infections or reactivation following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic therapy). Participants will be followed for one year.

Who can participate

Age range1 Month

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

✓. Adult or pediatric patient suffering from CMV reactivation/infections following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic therapy).
✓. Recipients of an allogeneic HSCT must be 28 days after stem cell infusion at the time of T-cell transfer.
✓. Written informed consent given by patient or legal representative.
✓. Minimum patient age 1 month.
✓. Minimum weight 7 lbs.
✓. Female patients of childbearing age with negative pregnancy tests.
✓. Patient Karnofsky/Lansky Performance Status \>30%.
✓. Donor eligible based on FACT infectious screening requirements.

Exclusion criteria

✕. Patient with acute GVHD \> grade 2 or active moderate or severe chronic GVHD at time of T-cell transfer
✕

What they're measuring

Feasibility: Number of Participants Who Drop-Out Before T-Cell Transfer

Timeframe: up to 21 days from enrollement

Feasibility: Number of Days from Participant Enrollment to Administration of CMV-VST

Timeframe: up to 21 days from enrollment

Feasibility: Successful production of CMV-VST from donors

Timeframe: up to 21 weeks from enrollment

Safety: Number of Subjects who experience infusion-related adverse events following CMV-VST infusion

Timeframe: up to 4 hours after CMV-VST infusion

Safety: Number of Subjects who experience newly occurring acute GVHD grade 1

Timeframe: up to 12 weeks from CMV-VST infusion

Safety: Number of subjects experiencing newly occurring acute GVHD grade ≥ 2 or experience aggravation of pre-existing acute GVHD

Timeframe: up to 12 weeks from CMV-VST infusion

Safety: Number of subjects experiencing chronic GVHD

Timeframe: up to 12 weeks from CMV-VST infusion

Trial details

NCT IDNCT03798301

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-31

View on ClinicalTrials.gov More CMV Infection trials

Plain-language summary

Who can participate

Age range1 Month

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

✓. Adult or pediatric patient suffering from CMV reactivation/infections following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic therapy).
✓. Recipients of an allogeneic HSCT must be 28 days after stem cell infusion at the time of T-cell transfer.
✓. Written informed consent given by patient or legal representative.
✓. Minimum patient age 1 month.
✓. Minimum weight 7 lbs.
✓. Female patients of childbearing age with negative pregnancy tests.
✓. Patient Karnofsky/Lansky Performance Status \>30%.
✓. Donor eligible based on FACT infectious screening requirements.

Exclusion criteria

✕. Patient with acute GVHD \> grade 2 or active moderate or severe chronic GVHD at time of T-cell transfer
✕

What they're measuring

Feasibility: Number of Participants Who Drop-Out Before T-Cell Transfer

Timeframe: up to 21 days from enrollement

Feasibility: Number of Days from Participant Enrollment to Administration of CMV-VST

Timeframe: up to 21 days from enrollment

Feasibility: Successful production of CMV-VST from donors

Timeframe: up to 21 weeks from enrollment

Safety: Number of Subjects who experience infusion-related adverse events following CMV-VST infusion

Timeframe: up to 4 hours after CMV-VST infusion

Safety: Number of Subjects who experience newly occurring acute GVHD grade 1

Timeframe: up to 12 weeks from CMV-VST infusion

Safety: Number of subjects experiencing newly occurring acute GVHD grade ≥ 2 or experience aggravation of pre-existing acute GVHD

Timeframe: up to 12 weeks from CMV-VST infusion

Safety: Number of subjects experiencing chronic GVHD

Timeframe: up to 12 weeks from CMV-VST infusion