Trial Title:
Intravesical Adoptive Cell Therapy w/ TIL for BCG Exposed High Grade NMIBC
NCT ID:
NCT05768347
Condition:
Urothelial Carcinoma
Non-Invasive Bladder Urothelial Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Transitional Cell
Conditions: Keywords:
Bladder cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Adoptive Cell Therapy with Tumor-infiltrating Lymphocytes (TIL)
Description:
Tissue samples are harvested, prepared and cryopreserved from post Bacillus
Calmette-Guerin (BCG) bladder biopsies.
Arm group label:
Treatment with Adoptive Cell Therapy
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).
Criteria for eligibility:
Criteria:
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
document.
Exclusion Criteria:
- Any previous treatment with intravesical chemotherapy within the previous 6 months.
- Current or prior use of any immunosuppressive medications, such as corticosteroids,
within 14 days before enrollment. (a) Oral hydrocortisone, only for the purposes of
a documented and confirmed adrenal insufficiency diagnosis, is permitted if ≤ 25 mg
daily total dose. (b) Inhaled, intranasal, or topical corticosteroids are permitted.
- Current or prior use of anticancer therapy that has been shown to effect lymphocyte
function before TIL collection.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic
congestive heart failure, unstable angina pectoris, cardiac arrhythmia (other than
stable atrial fibrillation).
- Patients known to be HIV positive, hepatitis B or C positive, or both rapid plasma
reagin (RPR) and fluorescent treponemal antibody (FTA) positive. (Hepatitis B
surface or core antibody alone is not indicative of Hepatitis B Virus (HBV)
infection).
- Known history of previous tuberculosis
- Receipt of live attenuated vaccination within 30 days prior to first anticipated
dose of TIL.
- History of allogeneic organ transplant
- History of primary immunodeficiency
- Any condition that, in the opinion of the investigator, would interfere with
evaluation of study treatment or interpretation of patient safety or study results.
- Patients with active systemic infections requiring intravenous antibiotics within 1
week prior to enrollment.
- Any unresolved toxicity (>CTCAE v5 grade 2) from previous anti-cancer therapy.
Subjects with irreversible toxicity that is not reasonably expected to be
exacerbated by the investigational product may be included (e.g., hearing loss,
peripheral neuropathy).
- History of pneumonitis or drug-related inflammatory lung disease.
- Active or prior documented autoimmune disease within the past 2 years. Note:
Subjects with vitiligo, Grave's disease, limited site eczema, or limited site plaque
psoriasis not requiring systemic treatment (within the past 2 years), or other
autoimmune conditions which are not expected to recur, are allowed after approval
from the medical monitor or PI.
- Patients with other prior malignancies must have had a ≥ 2-year disease-free
interval, except for: in situ carcinoma of the cervix, in situ ductal carcinoma of
the breast, in situ prostate cancer, in situ bladder cancer. These must have been
deemed stable and not expected to relapse. In addition, early stage skin cancers,
including basal, squamous cell cutaneous carcinoma, and melanoma, are permitted if
previously treated with curative intent and not expected to relapse.
- Women who are pregnant or lactating.
- The effects of adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TIL)
infusion on the developing human fetus are unknown. For this reason, women of
child-bearing potential (WOCBP) and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation and until 4 months after completion of study
drug administration. Those who do not agree must be excluded. Should a woman become
pregnant or suspect she is pregnant while she or her partner is participating in
this study, she should inform her treating physician immediately. WOCBP are defined
as premenopausal women capable of becoming pregnant.
- Penicillin allergy (Penicillin is used in the manufacturing of the cellular therapy
product and therefore patients with a documented penicillin allergy are excluded
from the trial)Patients with antibiotic allergies per se are not excluded; although
the production of TIL for adoptive transfer includes antibiotics, extensive washing
after harvest will minimize systemic exposure to antibiotics.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kim Sprenger
Phone:
813-745-0330
Email:
kimberly.sprenger@moffitt.org
Investigator:
Last name:
Michael A Poch, MD
Email:
Principal Investigator
Investigator:
Last name:
Scott Gilbert, MD
Email:
Sub-Investigator
Investigator:
Last name:
Roger Li, MD
Email:
Sub-Investigator
Investigator:
Last name:
Brandon Manley, MD
Email:
Sub-Investigator
Investigator:
Last name:
Wade Sexton, MD
Email:
Sub-Investigator
Investigator:
Last name:
Philippe Spiess, MD
Email:
Sub-Investigator
Investigator:
Last name:
Alice Yu, MD
Email:
Sub-Investigator
Investigator:
Last name:
Logan Zemp, MD
Email:
Sub-Investigator
Start date:
August 10, 2023
Completion date:
January 2026
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Collaborator:
Agency:
United States Department of Defense
Agency class:
U.S. Fed
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05768347
https://www.moffitt.org/clinical-trials-research/clinical-trials/
