Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
M-CENK · 1 trial · 1 indication
\- Safety of apheresis collection as indicated by incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) related to apheresis, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, or in the case of cytokine release syndrome (CRS), using the specified grading system.
\- Clinical lab tests include hematology (CBC w/ differential (5 part) including platelet count) and chemistry panel (BUN, blood urea nitrogen; CBC, complete blood count; RBC, red blood cells; ALT, alanine aminotransferase; AST, aspartate aminotransferase; ALP, alkaline phosphatase) performed within 1 calendar day prior to apheresis collection. Hematology test will be performed pre- and post- apheresis collection.
\- Vital signs to include temperature, respiratory rate, heart rate, blood pressure, and oxygen saturation
\- Incidence of TEAEs and SAEs, graded using the NCI CTCAE Version 5.0, or in the case of CRS using the specified grading system.
\- Clinical lab tests include hematology (CBC w/ differential (5 part) including platelet count) and chemistry panel (BUN, blood urea nitrogen; CBC, complete blood count; RBC, red blood cells; ALT, alanine aminotransferase; AST, aspartate aminotransferase; ALP, alkaline phosphatase) performed within 1 calendar day prior to first dose.
\- Vital signs to include temperature, respiratory rate, heart rate, blood pressure, and oxygen saturation
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Subjects newly diagnosed no prior therapy or prior first line treatment | EXPERIMENTAL | Cohort 1: Subjects with either newly diagnosed solid tumors who have not received prior therapy or subjects who have received prior first line treatment. Cohort 1 may subsequently enroll in cohort 2 part B if they have progressive disease after ≥ 2 prior therapies or if they have progressive disease within 12 months of receiving neoadjuvant or adjuvant chemotherapy and meet the inclusion criteria for cohort 2 part B. |
| Cohort 2: Subjects with relapsed/refractory (r/r) solid tumors | EXPERIMENTAL | Cohort 2: Subjects with relapsed/refractory (r/r) solid tumors who have progressive disease after receiving ≥ 2 prior therapies or not a candidate for therapy of proven efficacy for their disease. |
| Name | Type | Description |
|---|---|---|
| M-CENK, Suspension for Infusion, Cryopreserved (M-CENK) (Cohort 2 part B) | BIOLOGICAL | M-CENK will be administered up to 10 times weekly via intravenous (IV) infusion starting on study day 1 with a minimum of 7 days between each M-CENK dose. The dose of MCENK will be 0.25 - 0.75 × 10e9 cells per infusion. |
| N-803 (Cohort 2 part B) | BIOLOGICAL | N-803 15 μg/kg will be administered subcutaneously prior to every other dose of M-CENK for up to 5 doses of N-803. |
| Apheresis collection of MNCs (part A) | OTHER | Subjects in cohort 1A will participate in apheresis collection of lymphocytes (part A) and will not receive any investigational therapy in this study. |
Inclusion Criteria: Cohorts 1 and 2, Part A: * Age ≥ 18 years old. * Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. * Have histologically confirmed locally advanced, unresectable...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
M-CENK is an investigational autologous cell therapy being studied for locally advanced or metastatic solid tumors. It is a cryopreserved suspension for infusion and is classified as a monoclonal antibody-based product. ImmunityBio, Inc. is developing it, and it has not been approved for any use.
M-CENK is being studied in adults with locally advanced or metastatic solid tumors. The research is at an early stage, so M-CENK is not an approved treatment and is available only to participants enrolled in its clinical trial.
M-CENK is developed by ImmunityBio, Inc., which trades on the Nasdaq under the ticker IBRX. The company is running the clinical program for this autologous cell therapy in advanced solid tumors.
M-CENK is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single Phase 1 study is currently active but no longer recruiting participants.
M-CENK is being evaluated in the QUILT-3.076 study, registered as NCT04898543, titled Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors. The Phase 1 trial is active but not recruiting, is controlled, and plans to enroll 50 participants in the United States.
Yes. M-CENK is also referred to as M-CENK, Suspension for Infusion, Cryopreserved, and as M-CENK, for Infusion, Cryopreserved. These names describe the same cryopreserved autologous product given by infusion in the Phase 1 solid tumor study.