Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as N-803 (Cohort 2 part B), N-803 and BCG, N803, N-803 (IL-15 Superagonist)
N-803 · 5 trials · 5 indications
Measured by RECIST v1.1 and iRECIST
Measured by RECIST v1.1 and iRECIST
Measured by RECIST v1.1 and iRECIST
Measured by RECIST v1.1 and iRECIST
Measured by RECIST v1.1 and iRECIST and survival status
Measured by the CA-125 result
Response Criteria in Solid Tumors (RECIST) V1.1
Incidence of SAEs and overall AEs coded in MedDRA
| Arm | Type | Description |
|---|---|---|
| Cohort A: Experimental Arm | EXPERIMENTAL | 3-week cycles. N803, Tislelizumab, and Docetaxel will be administered on Cycle 1 and 2. N803 and Tislelizumab will be administered on Cycle 3 and onward until end of study. |
| Cohort A: Control Arm | ACTIVE_COMPARATOR | The control arm treatment regimen will consist of repeated 3-week cycles with a ± 3-day window for each visit of Docetaxel 75 mg/m2 IV. |
| Cohort B: Experimental Arm | EXPERIMENTAL | 3-week cycles. N803, prior failed checkpoint inhibitor, and Docetaxel will be administered on Cycle 1 and 2. N803 and prior failed checkpoint inhibitor will be administered on Cycle 3 and onward until end of study. |
| Cohort B: Control Arm | ACTIVE_COMPARATOR | The control arm treatment regimen will consist of repeated 3-week cycles with a ± 3-day window for each visit of Docetaxel 75 mg/m2 IV. |
| N-803 | EXPERIMENTAL | All patients will be in this arm. |
| All subjects | EXPERIMENTAL | Gemcitabine plus M-CENK plus N-803 |
| Cohort A Control Treatment Arm | ACTIVE_COMPARATOR | SBRT + gemcitabine + nab-paclitaxel |
| Cohort A Experimental Treatment Arm 1 | EXPERIMENTAL | SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel + aldoxorubicin HCl + N-803 |
| Cohort A Experimental Treatment Arm 2 | EXPERIMENTAL | SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel+ aldoxorubicin HCl + N-803 + PD-L1 t-haNK |
| Cohort B Control Treatment Arm | ACTIVE_COMPARATOR | Irinotecan liposome + 5-FU/leucovorin |
| Cohort B Experimental Treatment Arm | EXPERIMENTAL | SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel+ aldoxorubicin HCl + N-803 + PD-L1 t-haNK |
| Cohort C Experimental Treatment Arm | EXPERIMENTAL | SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel + aldoxorubicin + N-803 + PD-L1 t-haNK |
| Healthy Subjects | EXPERIMENTAL | Subjects will be scheduled for first apheresis collection on study Day 1. All subjects will receive N-803 at a fixed dose of 1 mg by subcutaneous (SC) injection 4 to 5 days prior to the second apheresis collection. The study day for N-803 administration will be determined based on the planned date of the second apheresis collection. |
| Name | Type | Description |
|---|---|---|
| N-803 | DRUG | N-803 1.2 mg SC |
| Tislelizumab | DRUG | Tislelizumab 200 mg IV |
| Docetaxel | DRUG | Docetaxel 75 mg/m2 IV |
| Prior failed checkpoint inhibitor | DRUG | Previously failed checkpoint inhibitor |
| N-803 (IL-15 Superagonist) | DRUG | N-803 administered subcutaneously. |
| Gemcitabine | DRUG | Dose: 800 mg/m2 intravenously (IV) Frequency: administered on Day 1, Day 8, and Day 15 of each cycle (every 4 weeks) |
| M-CENK | BIOLOGICAL | Dose: 0.15 to 0.75 × 109 cells per infusion intravenously (IV) Frequency: administered on Day 1 of each cycle as long as M-CENK cells are available. |
| Aldoxorubicin HCl | DRUG | Aldoxorubicin hydrochloride |
| PD-L1 t-haNK | BIOLOGICAL | PD-L1 t-haNK suspension for infusion |
| Nab-paclitaxel | DRUG | Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin |
| Cyclophosphamide | DRUG | 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate |
| 5-Fluorouracil | DRUG | 5-fluoro-2,4 (1H,3H)-pyrimidinedione |
| Leucovorin | DRUG | L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt |
| SBRT | PROCEDURE | Stereotactic Body Radiation Therapy |
| Irinotecan liposome | DRUG | Irinotecan hydrochloride trihydrate is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano\[3',4':6,7\]-indolizino\[1,2-b\]quinolin-9-yl-\[1,4'bipiperidine\]-1'-carboxylate, monohydrochloride, trihydrate |
Eligibility Criteria: Women and men of all races and ethnic groups are eligible for this trial. Cohort A Inclusion Criteria: 1. Age ≥ 18 years old. 2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Commit...
N-803 is an investigational IL-15 superagonist being studied for multiple cancers, including relapsed or refractory Non-Hodgkin's Lymphoma, B-cell Non-Hodgkin Lymphoma, bladder cancer, non-muscle invasive bladder cancer (NMIBC), non-small cell lung cancer, and pancreatic cancer. It is also being evaluated in trials for platinum-resistant ovarian cancer and Long COVID.
N-803 targets IL-15, a cytokine that stimulates the immune system. As an IL-15 superagonist, it is designed to enhance the activity of natural killer cells and T cells, which may help the body fight cancer. The drug is being studied in combination with other therapies, such as BCG for bladder cancer.
N-803 is developed by ImmunityBio, Inc., a biopharmaceutical company traded on NASDAQ under the ticker IBRX. The company is conducting clinical trials of N-803 across multiple indications, including bladder cancer and lymphoma.
N-803 is in Phase 1 and Phase 2 clinical trials. It is not FDA approved and remains investigational. Active trials include a Phase 1 study in relapsed or refractory Non-Hodgkin's Lymphoma and Phase 2 studies in bladder cancer, ovarian cancer, and Long COVID.
N-803 is being studied in several trials, including NCT03022825, a Phase 2 trial of intravesical BCG plus N-803 in BCG-unresponsive high-grade non-muscle invasive bladder cancer, and NCT05618925, a Phase 1 trial in relapsed or refractory Non-Hodgkin's Lymphoma. Other trials include NCT06710288 in ovarian cancer and NCT07108036 in Long COVID.
N-803 is also known as ALT-803, as referenced in the QUILT-3.032 trial title. It is an IL-15 superagonist developed by ImmunityBio. The drug is referred to by multiple names, including N803 and N-803 (IL-15 Superagonist), across different studies.