Non-muscle Invasive Bladder Cancer (NMIBC)Phase 2NCT06829823
Clinical Trial of Ablation Therapy in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer
A Phase 2 study testing N-803 and BCG and N-803 and Gemcitabine in people with Non-muscle Invasive Bladder Cancer (NMIBC), run by ImmunityBio, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer (NMIBC)
- What is being tested?
- N-803 and BCG and N-803 and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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)
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- 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.
- History or evidence of uncontrollable central nervous system [CNS] disease.
- Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.
- Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions.
- Ongoing chronic systemic steroid therapy required (>10 mg oral prednisone daily or equivalent).
- Women who are pregnant or nursing. Female participants of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for 7 months after the last dose of study drug, or be surgically sterilized (eg, hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study and for 90 days post last dose of study drug.
- Other illness or condition, including laboratory abnormalities, which in the opinion of the Investigator would exclude the participant from participating in this study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Christine Rose Phipps contact
About this study
Official title: Phase 2 Clinical Trial of Ablation Therapy With Intravesical N-803 In Combination With BCG or Gemcitabine in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer
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).
- Being tested
- N-803 and BCG, N-803 and Gemcitabine
- Keywords
- ResQ132A-NMIBC, Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer, BCG, Gemcitabine, N-803
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-803 and BCGDrug
Also called BCG, N-803, Bacillus Calmette-Guérin
Combination therapy N-803 plus BCG
N-803 and GemcitabineDrug
Also called N-803, Gemcitabine, Gemzar
Combination therapy N-803 plus Gemcitabine
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: N-803 and Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Month 3 and Month 6
Secondary outcomes (1)
Efficacy of Arms A and B at by CR rate at each response assessment
Evaluate efficacy of experimental therapy by CR rate at each response assessment.
Measured: At Month 3 through Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study startNov 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-muscle Invasive Bladder Cancer (NMIBC)Studies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829823
- Sponsor's protocol ID
- ResQ132A-NMIBC
- Status last verified
- Oct 2025
- First submitted
- 5 Feb 2025
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Clinical Trial of Ablation Therapy With Intravesical N-803 In Combination With BCG or Gemcitabine in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer
- ClinicalTrials.gov ID
- NCT06829823
- Acronym / sponsor ID
- ResQ132A-NMIBC
- Keywords
- ResQ132A-NMIBC, Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer, BCG, Gemcitabine, N-803
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-803 and BCG | Experimental | Drug: N-803 and BCGCombination 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 | Drug: N-803 and GemcitabineCombination 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (21 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-803 and BCGAlso: BCG, N-803, Bacillus Calmette-GuérinCombination therapy N-803 plus BCG | Drug | N-803 and BCG |
| N-803 and GemcitabineAlso: N-803, Gemcitabine, GemzarCombination therapy N-803 plus Gemcitabine | Drug | N-803 and Gemcitabine |
Primary outcome
Efficacy of Arms A and B at Month 3 and Month 6
Time frame: 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.
1 secondary outcome
Efficacy of Arms A and B at by CR rate at each response assessment
Time frame: At Month 3 through Month 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Rose Phipps contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-803 and BCG and N-803 and Gemcitabine in people with Non-muscle Invasive Bladder Cancer (NMIBC), run by ImmunityBio, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jayson Garmizo (310-912-2230, jayson.garmizo@immunitybio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Arms A and B at Month 3 and Month 6 (time frame: At Month 3 and Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.