Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the safety, pharmacokinetics, and pharmacodynamics of NKTT120 in adult patients with stable sickle cell disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NKTT120 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NKTT120 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by (1) adverse events (2) laboratory values (3) vital signs and (4) physical exam. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics assessed by plasma drug concentration levels | 0; 15, 30, 60 minutes; 3,6, hours; 1,2,3,7,14,30,60,90 days | |
| Pharmacodynamics as measured by assessments of peripheral blood lymphocyte subsets | 0, 0.25, 1, 2, 7, 14, 30, 60, 90, 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores as assessed by daily electronic diary | Daily for 120 days | |
| Quality of Life as assessed by two separate Quality of Life instruments | 0, 30, 60, 90, 120 days | |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rosemary Mazanet, MD | NKT Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital & Research Center at Oakland | Oakland | California | 94609 | United States | ||
| Johns Hopkins School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28152086 | Derived | Field JJ, Majerus E, Ataga KI, Vichinsky EP, Schaub R, Mashal R, Nathan DG. NNKTT120, an anti-iNKT cell monoclonal antibody, produces rapid and sustained iNKT cell depletion in adults with sickle cell disease. PLoS One. 2017 Feb 2;12(2):e0171067. doi: 10.1371/journal.pone.0171067. eCollection 2017. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lung function as measured by pulmonary function tests |
| 0; 30 minutes; 30, 60, 90, 120 days |
| Baltimore |
| Maryland |
| 21205 |
| United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| UNC Sickle Cell Program | Chapel Hill | North Carolina | 27514 | United States |
| Blood Center of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C000611532 | NKTT120 |
Not provided
Not provided
Not provided