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Also known as N-803 (Cohort 2 part B), N-803, N-803 and BCG, N-803 (IL-15 Superagonist)
N803 · 2 trials · 2 indications
determination of a dose level for the phase 2 study (RP2D)
determination of a dose level for the phase 2 study (RP2D)
Safety of CD19 t-haNK will be assessed by incidence and severity of TEAEs and SAEs, as well as incidence of clinically significant in safety laboratory tests and vital signs
| Arm | Type | Description |
|---|---|---|
| N-803 | EXPERIMENTAL | Participants receive N-803 subcutaneously (SubQ) administered on day 1 of each 21-day cycle for up to 6 cycles. |
| Arm A | EXPERIMENTAL | Subjects in both cohorts will initially receive lymphodepleting chemotherapy followed by a single 4-week cycle of the CD19 t-haNK single-agent regimen. Following a 1-week rest period, subjects will then receive lymphodepleting chemotherapy followed by a single 4-week cycle of CD19 t-haNK in combination with rituximab |
| Arm B | EXPERIMENTAL | Subjects in both cohorts will initially receive lymphodepleting chemotherapy followed by a single 4-week cycle of the CD19 t-haNK single-agent regimen. Following a 1-week rest period, subjects will then receive lymphodepleting chemotherapy followed by a single 4-week cycle of CD19 t-haNK in combination with rituximab (cohort A) or in combination with rituximab and N-803 (cohort B). |
| Name | Type | Description |
|---|---|---|
| N803 | DRUG | N-803 subcutaneously (SubQ) administered on day 1 of each 21-day cycle for up to 6 cycles. |
| CD19t-haNK suspension | BIOLOGICAL | Derived from the parental NK-92 (aNK) cell line, CD19 t-haNK is a human, allogeneic, NK cell line that has been engineered to express a CAR targeting CD19. Similar to the haNK cell line, CD19 t haNK has also been engineered to produce endoplasmic reticulum-retained IL 2 and the high-affinity (158V) variant of the Fcγ receptor (FcγRIIIa/CD16a), and thereby has enhanced CD16-targeted ADCC capabilities. CD19 t-haNK is similar to PD L1 t-haNK, differing only in the CAR that is expressed (CD19 vs PD-L1). |
| Cyclophosphamide | DRUG | Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate and has the molecular formula C7H15Cl2N2O2P•H2O and a molecular weight of 279.1. |
| Fludarabine | DRUG | Fludarabine phosphate is a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-β-D-arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. The chemical name for fludarabine phosphate is 9H-Purin-6-amine, 2-fluoro-9-(5-0-phosphono β-D-arabino-furanosyl) (2-fluoro-ara-AMP). The molecular formula of fludarabine phosphate is C10H13FN5O7P and it has a molecular weight of 365.2. |
| Rituximab | DRUG | Rituximab is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab has an approximate molecular weight of 145 kD and has a binding affinity for the CD20 antigen of approximately 8.0 nM. |
Inclusion Criteria: * Subjects aged ≥ 18 years. * Subjects with histologically confirmed B-cell NHL who have received commercially approved CD19-directed CAR T-cell therapy per FDA label * Subjects achieving CR or PR per Lugano Criteria to CAR T-cell therapy on D+30 post-CAR-T. * ECOG Performance S...
N-803 is an investigational small molecule being studied for use in several cancers, including NSCLC Stage IV, pancreatic cancer, B-cell Non-Hodgkin Lymphoma, and platinum-resistant ovarian cancer. It is also being evaluated in healthy subjects. The drug is in clinical development and has not been approved by the FDA.
N-803 targets IL-15, a cytokine involved in immune system regulation. By interacting with this target, the drug is designed to modulate immune responses, which may be relevant in cancer treatment. It is being studied in combination with other therapies for various malignancies.
N-803 is developed by ImmunityBio, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple cancer indications. ImmunityBio is publicly traded under the ticker symbol IBRX.
N-803 is in Phase 1 clinical development, though some trials are in Phase 2 and Phase 3. The drug is investigational and not yet approved. Clinical trials are ongoing or recently completed across various cancer types, including non-small cell lung cancer and pancreatic cancer.
N-803 is being studied in several trials, including NCT03228667 for multiple cancers, NCT04390399 for pancreatic cancer, NCT06745908 for NSCLC Stage IV, and NCT07049432 for B-cell Non-Hodgkin Lymphoma. These trials are at different phases and enrollment stages.
Yes, N-803 is also known as N803. It is sometimes referred to with additional descriptors, such as N-803 and BCG, N-803 plus Pembrolizumab, or N-803 (IL-15 Superagonist). These names all refer to the same investigational drug.