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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01570283 | ARMS - Rapidly Generated Multivirus-Specific CTLs for Prophylaxis & Treatment of EBV, CMV, Adenovirus, HHV6 & BK Virus | PHASE1 | COMPLETED | 21 | — | — | Sep 1, 2012 | Sep 1, 2017 | May 30, 2019 | 2 | United States |
DLT is defined as acute GvHD grades III-IV within 42 days of the last dose of CTLs, # of patients with Grade 3-5 infusion-related adverse events within 30 days of the last dose of CTLs, and # of patients with Grade 4-5 non-hematological adverse events within 30 days of the last dose of CTLs. GVHD grade III-IV scoring is based on the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) GVHD scoring stamp or equivalent. Grade 3-5 infusion-related adverse events and Grade 4-5 non-hematological adverse events are graded by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.X.
| Arm | Type | Description |
|---|---|---|
| Multivirus-specific T cells 5*10^6 mCTLs/m2 for Prophylaxis | EXPERIMENTAL | Cohort 1 prophylaxis: Participants were administrated 5\*10\^6 mCTLs/m multivirusspecific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| Multivirus-specific T cells 5*10^6 mCTLs/m2 for Treatment | EXPERIMENTAL | Cohort 1 treatment: Participants were administrated 5\*10\^6 mCTLs/m multivirusspecific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| Multivirus-specific T cells 1*10^7 mCTLs/m2 for Prophylaxis | EXPERIMENTAL | Cohort 2 prophylaxis: Participants were administrated 1\*10\^7 mCTLs/m multivirusspecific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| Multivirus-specific T cells 1*10^7 mCTLs/m2 for Treatment | EXPERIMENTAL | Cohort 2 treatment: Participants were administrated 1\*10\^7 mCTLs/m multivirusspecific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Prophylaxis | EXPERIMENTAL | Cohort 3 prophylaxis: Participants were administrated 2\*10\^7 mCTLs/m multivirusspecific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Treatment | EXPERIMENTAL | Cohort 3 treatment: Participants were administrated 2\*10\^7 mCTLs/m multivirusspecific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| Name | Type | Description |
|---|---|---|
| Multivirus-specific T cells Dose Level 1 | BIOLOGICAL | The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level. Dose Level One: 5x10\^6 mCTLs/m2 There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL. |
| Multivirus-specific T cells Dose Level 2 | BIOLOGICAL | The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level. Dose Level Two: 1x10\^7 mCTLs/m2 There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL |
| Multivirus-specific T cells Dose Level 3 | BIOLOGICAL | The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level. Dose Level Three: 2x10\^7 mCTLs/m2 There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL |
Inclusion Criteria: Patients will be eligible following any type of allogeneic transplant to receive CTLs as prevention or for early reactivations as defined below. 1. Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral bloo...