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Also known as N-803 (Cohort 2 part B), N-803, N803, N-803 (IL-15 Superagonist)
N-803 and BCG · 2 trials · 2 indications
Evaluate efficacy of experimental therapies with a) intravesical N-803 plus BCG or b) intravesical N-803 plus gemcitabine by CR rate at month 3 or month 6 (for re-inducted participants) in participants with intermediate-risk NMIBC.
Cohort A \& Cohort C: Assess incidence of complete response of CIS (with or without Ta/T1 papillary disease) patients at any time
Cohort B: Assess disease-free rate at 12 months since first study treatment
| Arm | Type | Description |
|---|---|---|
| N-803 and BCG | EXPERIMENTAL | Combination treatment of 1) N-803 (400 μg): Weekly for 6 weeks (induction, re-induction); Monthly from month 3 through month 15 (maintenance) and 2) BCG (50mg): Weekly for 6 weeks (induction, re-induction) |
| N-803 and Gemcitabine | EXPERIMENTAL | Combination treatment of 1) N-803 (400 μg): Weekly for 6 weeks (induction, re-induction); Monthly from month 3 through month 15 (maintenance) and 2) Gemcitabine (2000mg): Weekly for 6 weeks (induction, re-induction) |
| BCG+N-803 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| N-803 and BCG | DRUG | Combination therapy N-803 plus BCG |
| N-803 and Gemcitabine | DRUG | Combination therapy N-803 plus Gemcitabine |
| N-803 | DRUG | N-803 will be administered via intravesical instillation weekly for 6 consecutive weeks (induction). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36. |
Inclusion Criteria: * Age ≥ 18 years. * Low-grade (LG) Ta papillary disease as determined by Investigator. * History of LG NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT). Note: This refers to a previous episode(s) and not to the current episode for which the partic...
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N-803 is an investigational IL-15 superagonist being studied for several conditions, including platinum-resistant ovarian cancer, NSCLC Stage IV, B-cell Non Hodgkin Lymphoma, Non-muscle Invasive Bladder Cancer (NMIBC), and Non Hodgkin's Lymphoma Refractory/Relapsed. It is also being evaluated in healthy subjects and in combination with other therapies.
N-803 targets IL-15, a cytokine that plays a role in the immune system. As an IL-15 superagonist, it is designed to stimulate the proliferation and activation of natural killer cells and T cells, which may help the body fight cancer.
N-803 is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IBRX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer indications.
N-803 is in Phase 1 clinical development, with one active trial and one completed trial. It is an investigational drug and has not been approved by the FDA. The trials are assessing its use in conditions such as bladder cancer and healthy subjects.
N-803 is being studied in several clinical trials, including NCT03022825 (QUILT-3.032) for BCG-unresponsive high grade NMIBC, NCT03228667 (QUILT-3.055) for various cancers after checkpoint inhibitor treatment, NCT06040918 for healthy subjects, and NCT07108036 for Long COVID.
Yes, N-803 is also known as ALT-803. In clinical trials, it has been referred to as N-803 (IL-15 Superagonist) and is being studied in combination with BCG and pembrolizumab. The drug is developed by ImmunityBio, Inc.