Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02313857 | Most Closely Human Leukocyte Antigen (HLA)-Matched CMV-specific T Lymphocytes (Viralym-C) | PHASE1 | COMPLETED | 10 | — | — | Sep 1, 2015 | Feb 1, 2018 | Dec 26, 2018 | 2 | United States |
To determine if administration of banked CMV-specific T cells (Viralym-C) derived from healthy donors are safe in patients with CMV infection after allogeneic stem cell transplant.
| Arm | Type | Description |
|---|---|---|
| Viralym-C | EXPERIMENTAL | Partially HLA-matched Viralym-C cells will be thawed and given by intravenous injection. Patients will receive 2 x 10\^7 partially HLA-matched Viralym-C/m2 as a single infusion. If a patient has a partial response they are eligible to receive up to 4 additional doses at biweekly intervals. These doses would come from the original infused line if sufficient vials were available but may come from another line if there are insufficient cells in the original line. |
| Name | Type | Description |
|---|---|---|
| Viralym-C | BIOLOGICAL | Follow-up Assessments: The timing of follow-up visits is based on the date of Viralym-C infusion. If a patient has multiple Viralym-C infusions the schedule resets again at the beginning so follow up relates to the last Viralym-C infusion. Follow up will occur at 7 days, 14 days, 21 days, 28 days, 35 days, 42 days, 90 days, 180 days, and 365 days post enrollment. |
Inclusion Criteria: 1. Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells or single or double cord blood within 24 months. 2. Persistent or recurrent cytomegalovirus infection or disease despite at least 7 d...