NEW YORK, October 24, 2026 — A redesigned immunotherapy drug called 2141-V11 is now being tested in phase 1 and 2 clinical trials across nearly 200 patients with bladder, prostate, and brain cancers following promising early results.
Understanding the Drug and Early Results
According to reports from ScienceDaily and Rockefeller University, 2141-V11 is a CD40 agonist antibody engineered by researchers at Rockefeller University to improve effectiveness and reduce side effects. Early findings suggest that the redesigned antibody is ten times more powerful in eliciting an antitumor immune response than previous versions. In an initial phase 1 clinical trial of 12 patients with metastatic cancers published in the journal Cancer Cell in August 2025, six patients saw their tumors shrink and two experienced complete remission.
Previous clinical trials involving older CD40 agonist antibodies often failed due to serious adverse reactions, including widespread inflammation, low platelet counts, and liver damage, even at low doses. To avoid these systemic toxicities, researchers changed the delivery method. Instead of administering the drug intravenously, clinicians inject 2141-V11 directly into the tumor, according to Rockefeller University materials. This local delivery led to an unusual systemic response, where tumors not directly injected with the drug also shrank or were eliminated by immune cells.
“Seeing these significant shrinkages and even complete remission in such a small subset of patients is quite remarkable,” said Juan Osorio, a medical oncologist at Memorial Sloan Kettering Cancer Center and first author of the study, as reported by ScienceDaily.
Jeffrey V. Ravetch, who led the engineering of the antibody at Rockefeller University, noted in published statements that observing a systemic response from a local injection “is not something seen very often in any clinical treatment.”
Current Clinical Trials for Bladder, Prostate, and Brain Cancers
Building on these early results, nearly 200 patients are now enrolled in phase 1 and 2 studies at Memorial Sloan Kettering Cancer Center and Duke University, according to trial documentation. At Memorial Sloan Kettering, a phase 1/2 study is testing the safety and tolerability of 2141-V11 in patients with non-muscle-invasive bladder cancer that did not respond to standard BCG therapy, with the drug delivered directly into the bladder through a catheter, according to trial records.
Another trial at Memorial Sloan Kettering is a phase 2 study evaluating 2141-V11 combined with standard treatments prior to surgery for men with prostate cancer. According to trial details, this study includes patients with intermediate-risk disease, as well as those with high-risk localized or low-volume metastatic disease. Patients in the prostate trial may receive androgen deprivation therapy drugs to reduce hormone levels, along with medications such as enzalutamide, apalutamide, and darolutamide to block hormone effects, prior to undergoing radical prostatectomy and potential follow-up radiation therapy.
Additional studies are underway for glioblastoma, bringing the total patient participation across current phase 1 and phase 2 evaluations close to 200 individuals. CD40 functions as a cell surface receptor on immune cells belonging to the tumor necrosis factor receptor superfamily. When 2141-V11 binds to and activates CD40, it prompts the immune system to generate cancer-targeting T cells and mount a broader antitumor defense.
Guidance for Patients Considering Clinical Trials
For patients and families following these developments, the encouraging part is that researchers are finding new ways to direct the immune system against aggressive cancers. However, because these trials involve small sample sizes and remain ongoing, eligibility criteria are strict and specific to each cancer type and patient history. Anyone interested in learning more about these studies should talk to their doctor and consult their oncology care team to determine if a clinical trial aligns with their treatment plan.
Sources
- A Phase 2 Study of a Presurgical CD40 Agonist (2141-V11) Plus Standard Treatments in People With Prostate Cancer
- A Phase I Study of 2141-V11 Immunotherapy in People with Non-Muscle Invasive Bladder Cancer that Did Not Respond to Standard Treatment
- Scientists inject one tumor and watch cancer vanish across the body
- The rockefeller university
Photo: Kenneth C. Zirkel (CC BY-SA 4.0)
