Trial Outcomes & Findings for Donor-Derived Viral Specific T-cells (VSTs) for Prophylaxis Against Viral Infections After Allogeneic Stem Cell Transplant (NCT NCT03883906)

NCT ID: NCT03883906

Last Updated: 2022-12-13

Results Overview

Participants will be assessed for the presence of a toxicity.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2022-12-13

Participant Flow

Participant milestones

Measure	Viral Specific T-cells (VSTs) Viral Specific T-cells (VSTs): VSTs will be infused into stem cell transplant recipients
Overall Study STARTED	30
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Viral Specific T-cells (VSTs) Viral Specific T-cells (VSTs): VSTs will be infused into stem cell transplant recipients
Overall Study Withdrawal by Subject	2
Overall Study Physician Decision	5

Baseline Characteristics

Donor-Derived Viral Specific T-cells (VSTs) for Prophylaxis Against Viral Infections After Allogeneic Stem Cell Transplant

Baseline characteristics by cohort

Measure	Viral Specific T-cells (VSTs) n=30 Participants Viral Specific T-cells (VSTs): VSTs will be infused into stem cell transplant recipients
Age, Categorical <=18 years	27 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Participants will be assessed for the presence of a toxicity.

Outcome measures

Measure	Viral Specific T-cells (VSTs) n=23 Participants Viral Specific T-cells (VSTs): VSTs will be infused into stem cell transplant recipients
Number of Participants With Presence of a Toxicity	0 Participants

PRIMARY outcome

Timeframe: 30 days

Participants will be assessed for the presence of aGVHD.

Outcome measures

Measure	Viral Specific T-cells (VSTs) n=23 Participants Viral Specific T-cells (VSTs): VSTs will be infused into stem cell transplant recipients
Number of Participants With Acute Graft-Vs-Host Disease (aGVHD)	2 Participants

SECONDARY outcome

Timeframe: 30 days

Participants will be assessed for the presence of viral infection.

Outcome measures

Measure	Viral Specific T-cells (VSTs) n=23 Participants Viral Specific T-cells (VSTs): VSTs will be infused into stem cell transplant recipients
Number of Participants With Presence of a Viral Infection	14 Participants

Adverse Events

Viral Specific T-cells (VSTs)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Viral Specific T-cells (VSTs) n=23 participants at risk Viral Specific T-cells (VSTs): VSTs will be infused into stem cell transplant recipients
Skin and subcutaneous tissue disorders GVHD, skin	4.3% 1/23 • Number of events 1 • 30 days All adverse events that occur from the administration of first VST infusion through 30 days after the last VST infusion were recorded per the protocol. Events occurring greater than 30 days after the last VST infusion were assessed and recorded only when they are unexpected and determined to be at least possibly related to the VST infusion through 1 year after the last VST infusion.
Gastrointestinal disorders GVHD, stomach	4.3% 1/23 • Number of events 1 • 30 days All adverse events that occur from the administration of first VST infusion through 30 days after the last VST infusion were recorded per the protocol. Events occurring greater than 30 days after the last VST infusion were assessed and recorded only when they are unexpected and determined to be at least possibly related to the VST infusion through 1 year after the last VST infusion.
Gastrointestinal disorders GVHD, sigmoid colon & rectum	4.3% 1/23 • Number of events 1 • 30 days All adverse events that occur from the administration of first VST infusion through 30 days after the last VST infusion were recorded per the protocol. Events occurring greater than 30 days after the last VST infusion were assessed and recorded only when they are unexpected and determined to be at least possibly related to the VST infusion through 1 year after the last VST infusion.

Additional Information

Michael Grimley, MD

Cincinnati Children's Hospital Medical Center

Phone: 513-803-3218

Email: Michael.Grimley@cchmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place