Not Yet RecruitingPhase 2

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

20 participantsStarted 2025-11

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: At Month 3 and Month 6

Trial details

NCT IDNCT06829823

SponsorImmunityBio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11

Contact for this trial

Jayson Garmizo

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

View on ClinicalTrials.gov More Non-muscle Invasive Bladder Cancer (NMIBC) trials