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NCT03665675 · ClinicalTrials.gov registry record · Early Phase 1
Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT
A Early Phase 1 study of Adenovirus and Cytomegalovirus, sponsored by Sumithira Vasu.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT03665675: Recruiting Early Phase 1 study of Adenovirus and Cytomegalovirus, sponsored by Sumithira Vasu.
NCT03665675 is a Early Phase 1 study of Adenovirus and Cytomegalovirus that is actively recruiting participants, run by Sumithira Vasu. The registered enrollment target is 20 participants, below the 28-participant average among 6 other Adenovirus trials with a reported enrollment target (29% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03665675, a Early Phase 1 study of Adenovirus and Cytomegalovirus, is actively recruiting participants, sponsored by Sumithira Vasu.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
This trial studies the side effects and how well allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (donor cytomegalovirus \[CMV\] specific cytotoxic T-lymphocytes \[CTLs\]) or allogeneic adenovirus-specific cytotoxic T lymphocytes (donor adenovirus-specific \[AdV\] specific CTLs) work in treating CMV or AdV reactivation or infection in participants who have undergone stem cell transplant or solid organ transplant. White blood cells from donors may be able to kill cancer cells in patients with cytomegalovirus or adenovirus that has come back after a stem cell or solid organ transplant.
Primary Outcome
Measured as the proportion of patients with acute (a) graft versus host disease (GvHD) grades III-IV or graft rejection/failure within 30 days of the last dose of cytotoxic T-lymphocytes (CTLs) or grades 3-5 infusion-related adverse events within 7 days of the last does of CTLs or grades 4-5 non-hematological adverse events within 30 days of the last dose of CTLs and that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbidities. Will be calculated by di
Conditions Studied
Interventions
- BIOLOGICAL Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes
- BIOLOGICAL Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes
Study Locations (2)
Ohio
- Nationwide Children's Hospital - Columbus
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-11-07 |
| Est. Completion | 2026-04-20 |
| Phase | Early Phase 1 |
What NCT03665675 shows while recruiting
NCT03665675 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 28-participant average among 6 other Adenovirus trials with a reported enrollment target (29% lower).
The record links to 5 conditions, with Adenovirus appearing as the primary indexed condition, and to 2 interventions - of which Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes is the first listed.
NCT03665675 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT03665675 about?
NCT03665675 is a clinical study titled "Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT". This trial studies the side effects and how well allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (donor cytomegalovirus \[CMV\] specific cytotoxic T-lymphocytes \[CTLs\]) or allogeneic adenovirus-specific cytotoxic T lymphocytes (donor adenovirus-specific \[AdV\] specific CTLs) work in t...
What is the current status of trial NCT03665675?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2020-11-07. Estimated completion is 2026-04-20.
What conditions does trial NCT03665675 study?
This clinical trial studies the following conditions: Adenovirus, Cytomegalovirus, Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Donor, Solid Organ Transplantation Recipient.
What interventions are being tested in trial NCT03665675?
The interventions under investigation include: Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes (BIOLOGICAL), Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT03665675?
This trial is sponsored by Sumithira Vasu, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03665675 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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