Intravesical Adoptive Cell Therapy w/ TIL for BCG Exposed High Grade NMIBC (NCT05768347) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Intravesical Adoptive Cell Therapy w/ TIL for BCG Exposed High Grade NMIBC
United States9 participantsStarted 2023-08-10
Plain-language summary
The purpose of the study is to evaluate the feasibility, safety and tolerability of intravesical adoptive cell therapy using TIL (tumor infiltrating lymphocytes) in participants with urothelial cell carcinoma (UCC) non-muscle invasive bladder cancer (NMIBC).
Who can participate
Age range18 Years
SexALL
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Screening Inclusion Criteria:
* Bacillus Calmette-Guerin (BCG) exposed High Grade Non-Muscle Invasive Bladder Cancer (NMIBC) and healthy enough to participate:
* Histologically confirmed urothelial cell NMIBC (T1, Ta, and/or Tis) and: (a) bladder tumors with variant histology or mixed histology can be enrolled if the urothelial component is greater than 50% of the transurethral resection specimen (b) if Ta and T1, patients must have undergone complete restaging TURBT to confirm absence of muscle invasion (T2), however residual carcinoma in situ is acceptable. This restaging can be considered the primary tumor harvest if patients have had a previous resection.
* Have cytoscopic evidence of measurable disease. (There is no minimum measurement to be considered measurable disease. Any visible evidence is considered recurrence.)
* A tissue specimen may be obtained which is appropriate for TIL preparation. The tissue may be collected through a procedure the patient otherwise requires for treatment purposes. Alternatively, and in consultation with a surgical specialist, a separate procedure of limited risk to the patient (such as a repeat bladder biopsy) may be performed specifically for tissue collection purposes.
* ECOG performance status 0-1
* Participants must have adequate organ and marrow function in an assessment performed within 7 days (+ 3 day window) of enrollment as defined in protocol.
* Ability to understand and the willingness to sign a written informed consent docume…
What they're measuring
1
Safety of Adoptive Cell Therapy with TILs
Timeframe: Up to 6 months
Trial details
NCT IDNCT05768347
SponsorH. Lee Moffitt Cancer Center and Research Institute