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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04153279 | CMV-TCR-T Cells for CM Virus Infection After HSCT | PHASE1 | COMPLETED | 17 | — | — | Dec 19, 2019 | Nov 15, 2022 | Jan 12, 2023 | 1 | China |
Percentage of participants with adverse events.
| Arm | Type | Description |
|---|---|---|
| CMV-TCR-T cells | EXPERIMENTAL | The patients will receive one dose of CMV-TCR-T.The dosage ranges from 0.1×10\^6 to 1×10\^6 TCR+T/Kg. |
| Name | Type | Description |
|---|---|---|
| CMV-TCR-T cells | BIOLOGICAL | Patients with CMV emias or CMV disease will be enrolled, and donor derived CMV-TCR-T(HLA-A\*1101\\0201\\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 CMV-TCR-T cells. The CMV DNA copies and CMV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14,day 28). |
Inclusion Criteria: 1. Age 1-70 years, including boundary values, gender unlimited; 2. Allogenic hematopoietic stem cell transplantation patients with CMV infection disease or persistent CMV emia; 3. At least one of the following conditions after allogeneic HSCT: * After trested with 2-week sta...