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Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment

Phase I Study Evaluating the Safety and Tolerability of Locally Administered Anti-CD40 Agonist Antibody (2141-V11) in Subjects With Bladder Cancer

NCT05126472•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to test the safety of the study drug 2141-V11 in people whose NMIBC did not respond to standard treatment, and who will not have the standard surgical procedure to remove the bladder. The researchers will test different doses of 2141-V11 to see which dose is safest in people. The researchers will also do tests to see how the body absorbs, distributes, and gets rid of 2141-V11. This study is one of the first to test 2141-V11 in people, and the first to test 2141-V11 delivered through a catheter into the bladder.

Detailed Description

If during Period 1 treatment, the treating physician notices recurrent disease in the bladder, the patient should undergo a biopsy or TURBT. If the pathology returns as HG Ta or CIS, the patient can resume treatment. If pathology returns as HG T1, the patient will be removed from treatment. If a high-grade recurrence occurs during period 2 or 3 treatments, the patient will be removed from treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Cohorts A and B
•High-grade (HG) NMIBC (HG Ta, CIS, and/or T1) of urothelial histology that is unresponsive to adequate BCG therapy.
•Stage, grade, and histology must be confirmed by the MSK Department of Pathology
•Subjects with tumors of mixed urothelial/non-urothelial histology may be included, but urothelial carcinoma must be the predominant histology; subjects with predominant or exclusively non-urothelial histology are excluded
•In those subjects with CIS, the CIS must be present on the tumor sample from the most recent cystoscopy/TURBT
•In this context, adequate BCG therapy is defined as at least one of the following:
•At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy
•At least five of six doses of an initial induction course plus at least two of six doses of a second induction course
•Disease unresponsive to adequate BCG therapy is defined as the following. Suspected recurrence from suspicious cytology or cystoscopy, and later confirmed via TURBT, is acceptable:
•Persistent or recurrent CIS alone or with recurrent Ta/T1 disease (noninvasive papillary disease/tumor invades the subepithelial connective tissue) within 12 months of completion of adequate BCG therapy
+44 more criteria

Exclusion Criteria

•(Cohort A and B)
•History of or currently being treated for muscle-invasive (T2, T3, T4) locally-advanced non-resectable or metastatic urothelial carcinoma.
•Evidence of concurrent extravesical (i.e., urethra, ureter, or renal pelvis) urothelial cell carcinoma.
•Concurrent anti-cancer therapy, including investigational agents
•Exceptions include:
•Cohorts A and B Exceptions: Subjects on topical therapy (e.g. topical 5-
•Cohort C Exceptions: Subjects on topical therapy (e.g. topical 5-fluorouracil) and Neoadjuvant chemotherapy (e.g. cisplatin and gemcitabine)
•Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/TURBT to starting trial treatment (a single dose of intravesical treatment given as part of the most recent cystoscopy/TURBT, during the screening period, such as with chemotherapy as per local/regional practices, is acceptable).
•Has had prior chemotherapy, targeted small molecule therapy, cytokine therapy, or radiation therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to a previously administered agent.
•°Subjects with Grade ≤2 neuropathy or Grade ≤2 alopecia are an exception to this criterion and may qualify for the study
+23 more criteria

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Key Dates

Start Date

November 8, 2021

Primary Completion Date

November 1, 2026

Completion Date

November 1, 2026

Last Updated

September 4, 2025

Enrollment

ESTIMATED participants

Conditions

Non-muscle Invasive Bladder Cancer

Interventions

anti-CD40 antibody 2141-V11

DRUG

anti-CD40 antibody 2141-V11

DRUG

anti-CD40 antibody 2141-V11

DRUG

Contacts

Bernard Bochner, MD

CONTACT

646-422-4387 bochnerb@mskcc.org

Eugene Pietzak, MD

CONTACT

646-422-4781

Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients

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Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG

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Chemoablation Or Bladder Resection With Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer

NCT06781879

Non-Muscle Invasive Bladder Cancer

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A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment

Inclusion Criteria

Exclusion Criteria

Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients

Chemoablation Or Bladder Resection With Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer

A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer

Comparison of Pathological Outcome and Recurrence Rate Between En Bloc and Conventional Transurethral Resection of Bladder Tumor

A Phase III Randomised Control Clinical Trial of Radiotherapy With Radiosensitisation Versus Intravesical Bacillus Calmette-Guerin Therapy for High-risk Non-muscle Invasive Bladder Cancer.

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)