A Phase 1/2 interventional study of BCG (50mg/instillation) + N-803 (400 μg/instillation) and BCG (50mg/instillation) in Non-muscle Invasive Bladder Cancer, sponsored by ImmunityBio, Inc.. Active, not recruiting at 108 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by ImmunityBio, Inc. · Phase 1/2, Interventional, and Treatment
This is a Phase Ib/IIb, randomized, two-cohort, open-label, multicenter study of intravesical N-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC.
The study includes a dose escalation phase (phase Ib) and an expansion phase (phase IIb).
In the phase Ib, patients will be treated with intravesical N-803 in combination with BCG. The purpose of the phase Ib portion of the study is to evaluate the safety, identify the Maximum Tolerated Dose (MTD) of N-803 and determine the Recommended Dose (RD) level of N-803 in combination with BCG for the phase IIb expansion.
In the phase IIb expansion, patients will be randomized to receive either intravesical N-803 in combination with BCG or BCG alone. Patients will be enrolled into one of two study cohorts (Cohort A and Cohort B). These will be two independent study cohorts, evaluated separately for treatment efficacy.
265 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 113 are open to participants now.
This study's enrollment of 369 is above the median of 70 across 204 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Browse Non-Muscle Invasive Bladder Neoplasms studies →ImmunityBio, Inc. is the lead sponsor of 82 studies on the registry; 15 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 17 (74%) have results posted.
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Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology).
BCG-naive disease as defined as either of the following:
Laboratory tests performed within 21 days of treatment start:
Provide signed informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations.
Exclusion Criteria
(Phase Ib and IIb) for BCG-naive patients
Biological: BCG (50mg/instillation) + N-803 (400 μg/instillation)
(Phase IIb) for BCG-naive patients
Biological: BCG (50mg/instillation)
BCG and N-803 will be mixed together (with saline) and administered via intravesical instillation weekly for 6 consecutive weeks for induction. Phase IIb includes maintenance treatment consisting of BCG+N-803 for 3 consecutive weeks at 3, 6, 12, 18, 24, 30 and 36 months. An additional 6-week re-induction of BCG+N-803 for patients with eligible disease at 3 months in phase IIb is included.
BCG will be administered via intravesical instillation weekly for 6 consecutive weeks for induction. Phase IIb includes maintenance treatment consisting of BCG for 3 consecutive weeks at 3, 6, 12, 18, 24, 30 and 36 months. An additional 6-week re-induction of BCG for patients with eligible disease at 3 months in phase IIb is included.
Complete Response (CR) Rate
Patients in Cohort A: compare complete response rate between treatment arms using cystoscopy, confirmatory bladder biopsy and urine cytology.
Time frame: 6 Months
Disease Free Survival (DFS)
Patients in Cohort B: compare disease-free survival between treatment arms using cystoscopy, confirmatory bladder biopsy and urine cytology.
Time frame: 13 Years and 3 Months
Progression-free survival (PFS)
For phase IIb, Cohorts A \& B: Time from randomization to disease progression or death.
Time frame: 13 Years and 3 Months
Overall survival
Time from randomization to death resulting from any cause to determine survival.
Time frame: 13 Years and 3 months
Disease specific survival
For phase IIb, Cohorts A \& B: Time from randomization to death resulting from bladder cancer.
Time frame: 13 Years and 3 months
Time to disease worsening
For phase IIb, Cohorts A \& B: Cystectomy or change in therapy indicative of more advanced disease, including systemic chemotherapy or radiation therapy.
Time frame: 13 Years and 3 Months
Cystectomy Free Rate
Cystectomy-free rate will be calculated for each treatment group as the ratio of the number of subjects who don't have documented cystectomy in the database divided by the number of subjects in the ITT (Intent to treat) population.
Time frame: 13 years and 3 months
Safety Profile: Number and severity of treatment emergent AEs [Time Frame: 39 Months]
For phase Ib and phase IIb: Number of participants with TEAEs as assessed by CTCAE v4.03.
Time frame: 39 Months
Duration of Complete Response
To assess the duration of CR of patients treated with N-803 plus BCG compared to patients treated with BCG alone.
Time frame: 13 Years and 3 months
Complete Response Rate( All Recurrent Bladder Cancer Including Low Grade Ta Disease)
To assess the CR rate (all recurrent bladder cancer including low grade Ta disease) of patients treated with N-803 plus BCG compared to patients treated with BCG alone.
Time frame: 13 Years and 3 months
Long Term Complete Response Rate
To assess the long-term CR rate (as determined by the Investigator) following completion of QUILT-2.005 phase 2b.
Time frame: 13 years and 3 Months
Duration of Complete Response ( All Recurrent Bladder Cancer Including Low Grade Ta Disease)
Time from the date of first CR (All Recurrent bladder cancer including low grade Ta Disease) to the date of evidence that the subject no longer meets the definition for CR.
Time frame: 13 Years and 3 months
Cohort B: Disease Free Survival Rate
To assess DFS rate at 12, 18, 24, 30, and 36 months. The time from randomization until recurrence of high-grade Ta (excluding low grade Ta) or any grade T1, CIS, disease progression, cystectomy, change in therapy indicative of more advance disease or death (any cause), whichever occurs first.
Time frame: 36 Months
Cohort B: Disease Free Survival
DFS was assessed in the following groups: 1\) All recurrent bladder cancer, including low grade Ta disease the time from randomization until recurrence of any grade Ta (including low grade Ta) or any grade T1, CIS, disease progression, cystectomy, change in therapy indicative of more advanced disease, or death (any cause), whichever occurs first 2) Patients who have high-grade Ta, low-grade T1, or CIS at 3-months and received re-induction, and have no evidence of \> low-grade Ta disease at 6-months will be considered disease-free from randomization until a second recurrence \> low-grade Ta 3) Patients who have high-grade Ta, low-grade T1, or CIS at 3-months and received re-induction, and have no evidence of any disease (including low grade Ta) at 6-months will be considered disease-free from randomization until a second recurrence ≥ low grade Ta.
Time frame: 13 Years and 3 Months
Vital signs and clinical laboratory assessment
Vital signs include heart rate, systolic and diastolic blood pressures, respiration rate, and body temperature. Labs include the following: complete blood count with differential, complete metabolic panel, and urinalysis.
Time frame: 36 Months
Long Term Follow Up(LTFU) data from subjects who were treated
Yearly collection of LTFU data, which includes the following: survival status, bladder cancer status (high or low grade), cystoscopy results including number of cystoscopies done for each subject, biopsy results, upper tract evaluations, posttherapies and responses and outcomes of posttherapies, urine cytology results, and other medical history or treatments, if available, related to bladder cancer.
Time frame: 10 Years after treatment period visits
Exploratory Endpoints- Immunogenicity: Serum level of anti-N-803 in patient samples
For phase Ib and IIb Measures the serum level of anti-N-803 in patient samples.
Time frame: 36 Months
Quality of Life Endpoint
Quality of Life (QoL) as assessed by the European Organization for Research and Treatment of Cancer (EORTC) questionnaires for patients with cancer (QLQ-C30) and for patients with NMIBC (QLQ-NMIBC24).
Time frame: 39 Months
Exploratory Endpoints- Whole Slide Images (Baseline and any on-study biopsy)
For Phase IIb
Time frame: 39 Months
Showing the first 100 of 108 sites across 3 countries.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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ImmunityBio, Inc.