Clinical Trial of Ablation Therapy in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer

NCT06829823 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: ResQ132A-NMIBC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, phase 2, randomized study of intravesical N-803 plus BCG (experimental arm A) and intravesical N-803 plus gemcitabine (experimental arm B) in participants who have intermediate-risk Ta/T1 papillary disease. The primary objective of this study is to evaluate the efficacy of these experimental therapies without the need for surgical intervention by CR rate at month 3 or month 6 (for re-inducted participants).

Conditions

Non-muscle Invasive Bladder Cancer (NMIBC)

Keywords

ResQ132A-NMIBC; Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer; BCG; Gemcitabine; N-803

Outcome Measures

Primary Outcomes (1)

• Efficacy of Arms A and B at Month 3 and Month 6

  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.

  At Month 3 and Month 6

Secondary Outcomes (1)

• Efficacy of Arms A and B at by CR rate at each response assessment

  At Month 3 through Month 36

Study Arms (2)

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)

Drug: N-803 and BCG

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)

Drug: N-803 and Gemcitabine

Interventions

N-803 and BCG DRUG

Combination therapy N-803 plus BCG

Also known as: BCG, N-803, Bacillus Calmette-Guérin

N-803 and BCG

N-803 and Gemcitabine DRUG

Combination therapy N-803 plus Gemcitabine

Also known as: N-803, Gemcitabine, Gemzar

N-803 and Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 participant is being screened. Any presence of variant histology, or LVI should be deemed high-risk.
• Negative voiding cytology for HG disease within 12 weeks prior to screening.
• Intermediate-risk disease, defined as having 1 or 2 of the following:
• Presence of \>1 and \< 5 tumors;
• Solitary tumor \< 3 cm;
• Early or frequent recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis at the initial screening visit).
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
• Voluntary written informed consent and HIPAA authorization and agreement to comply with all protocol-specified procedures and follow-up evaluations.

You may not qualify if:

• Received BCG treatment for urothelial carcinoma.
• History of HG bladder cancer (papillary or CIS) in the past 2 years.
• Clinically significant urethral stricture that would preclude passage of a urethral catheter.
• Life expectancy \< 2 years.
• Any of the following clinical laboratory values at the time of enrollment:
• Absolute lymphocyte count (ALC) \> institutional lower limit of normal (LLN)
• Absolute neutrophil count (ANC) \< 800/μL
• Platelets \< 50,000/μL
• Aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]) \> 2 × upper limit of normal (ULN).
• Creatinine level \> 3 × ULN. Note: Each study site should use its institutional LLN/ULN to determine eligibility.
• History of or evidence of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer (inclusive of the prostatic urethra); or any other cancer within the past 5 years that is progressing or requires active treatment. Exceptions are adequately treated basal cell or squamous cell skin cancer that has undergone potentially curative therapy or in situ cervical cancer; adequately treated stage I or II cancer or stable prostate cancer from which the participant is currently in complete remission, and is under active surveillance or hormone control; or any other cancer that investigator feels is stable with permission of Medical Monitor.
• Suspicion of active upper tract urothelial malignancy.
• Currently receiving investigational or commercial anticancer agents or anticancer therapies other than BCG, N-803, and supportive care therapies for active disease.
• Symptomatic congestive heart failure (CHF), New York Heart Association (NYHA) Class III or IV heart failure, or other clinical signs of severe cardiac dysfunction.
• Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

ALT-803; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Jayson Garmizo

CONTACT

310-912-2230; jayson.garmizo@immunitybio.com

Christine Rose Phipps

CONTACT

Christine.Phipps@immunitybio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 17, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2029
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share