ResQ132EX-NMIBC: Expanded Access Use of Recombinant Bacillus Calmette-Guérin in Nonmuscle Invasive Bladder Cancer

ImmunityBio

Status

Conditions: NMIBC

Treatments: Biological: rMBCG

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT06810141

ResQ132EX-NMIBC

Details and patient eligibility

About

This expanded access protocol is designed to provide Recombinant Mycobacterium BCG (rMBCG) to patients with Non-muscle invasive bladder cancer (NMIBC) who are eligible to receive TICE® BCG, may benefit from its use, and who are ineligible to participate in a clinical trial using rMBCG, or for other reasons cannot participate (eg, geographically unable to access a study site).

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants must meet all of the following criteria for inclusion in the study:

1. Age ≥18 years old.
2. 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).
3. Ineligible to participate in a clinical trial using rMBCG or geographically unable to access a rMBCG clinical trial site.
4. Voluntary written informed consent and agreement to comply with all protocol specified procedures and follow-up evaluations.

Exclusion criteria

Participants with any of the following criteria are excluded from participation in the study:

1. 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.
2. 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 30 days 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.