Expanded Access to Recombinant BCG for Non-Muscle Invasive Bladder Cancer
Sponsor: ImmunityBio, Inc.
Expanded Access
Sponsor score: 60
ClinicalTrials ID:NCT06810141
This program provides access to a treatment called Recombinant BCG for patients with non-muscle invasive bladder cancer who cannot join a clinical trial for this treatment, either due to location or other reasons.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This program is designed to offer a treatment called Recombinant Mycobacterium BCG (rMBCG) to patients with non-muscle invasive bladder cancer (NMIBC) who are eligible for TICE® BCG but cannot participate in a clinical trial for rMBCG. This could be due to being too far from a trial site or other reasons that make trial participation impossible.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a confirmed diagnosis of non-muscle invasive bladder cancer, specifically the high-grade transitional cell carcinoma type.
- Cannot participate in a clinical trial for rMBCG due to ineligibility or geographic reasons.
- Must provide written consent and agree to follow all study procedures and evaluations.
Exclusion Criteria
- Any other illness or condition that the study doctor believes would prevent participation, including serious medical or psychiatric conditions.
- Women who are pregnant or breastfeeding cannot participate. Women who can become pregnant must have a negative pregnancy test and use birth control during the study and for 30 days after the last dose. Men must agree to use barrier birth control methods during the study and for 90 days after the last dose.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Urology Associates | 36607 | Mobile | Alabama |
| Genesis Care | 33908 | Fort Myers | Florida |
| Cohen Urology | 33449 | Lake Worth | Florida |
| Emory University | 30322 | Atlanta | Georgia |
| Advanced Urology Skokie | 60077 | Skokie | Illinois |
| Urology of Indiana | 46032 | Carmel | Indiana |
| First Urology, P.S.C | 47130 | Jeffersonville | Indiana |
| Kansas City Urology Care, PA | 66214 | Lenexa | Kansas |
| NRMC Urology Associates | 71457 | Natchitoches | Louisiana |
| Pioneer Valley Urology, P.C. | 01107 | Springfield | Massachusetts |
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