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Adoptive Cell Therapy
Adoptive Cell Therapy for Bladder Cancer
Phase 1
Recruiting
Led By Michael A Poch, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Bacillus Calmette-Guerin (BCG) exposed High Grade Non-Muscle Invasive Bladder Cancer (NMIBC) and healthy enough to participate
ECOG performance status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial will assess a new type of therapy for non-muscle invasive bladder cancer: adoptive cell therapy using TIL.
Who is the study for?
This trial is for individuals who have been treated with BCG for high-grade non-muscle invasive bladder cancer (NMIBC) and show evidence of the disease. They must be in good health, understand the study, and consent to participate. Key eligibility includes a performance status of 0-1, adequate organ function, no recent intravesical chemotherapy or immunosuppressive drugs, no uncontrolled illnesses or certain infections like HIV or hepatitis B/C.Check my eligibility
What is being tested?
The trial is testing adoptive cell therapy using TIL (tumor infiltrating lymphocytes) delivered directly into the bladder to see if it's safe and tolerable for treating urothelial cell carcinoma in NMIBC patients who have previously received BCG therapy.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions associated with cellular therapies such as immune-related inflammation, infusion reactions, fatigue, fever, chills or infection risks due to immune system modification.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a high-grade bladder cancer but haven't had muscle invasion, and I'm fit for participation.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of Adoptive Cell Therapy with TILs
Secondary outcome measures
Overall Response Rate
Progression Free Survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment with Adoptive Cell TherapyExperimental Treatment1 Intervention
TIL from bladder biopsies will be propagated and cultured with interleukin-2 (IL-2) to a target goal of >30 million cells. These TIL then undergo rapid clonal expansion (REP) by incubation with anti-CD3 monoclonal antibody (mAb), resulting in >500-fold expansion. After 4-6 weeks culture time intravesical TIL will be administered via intravesical infusion, consisting of up to 3.2e8 cells in 40 mL aliquot. Intravesical therapy will be administered for up to 2 hours. This treatment will occur four times (Day 0, Day 7, Day 14 and Day 21).
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Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,470 Total Patients Enrolled
United States Department of DefenseFED
865 Previous Clinical Trials
327,687 Total Patients Enrolled
Michael A Poch, MDPrincipal InvestigatorMoffitt Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've been cancer-free for 2 years, except for certain early-stage or in situ cancers.I haven't needed IV antibiotics for infections in the last week.You have received an organ transplant from another person.I have not received any live vaccines in the last 30 days.My bladder cancer is mostly urothelial and hasn't spread deep into the muscle.I do not have any severe illnesses like heart failure or unstable heart conditions.I can provide a tissue sample for the trial, either from a needed treatment or a low-risk procedure.I don't have severe side effects from past cancer treatments.I am not pregnant or breastfeeding and agree to use contraception during the study.I have used cancer treatments that affect immune cells before.I have not had bladder chemotherapy in the last 6 months.I have a high-grade bladder cancer but haven't had muscle invasion, and I'm fit for participation.I haven't taken any immune-weakening drugs in the last 14 days, except for low-dose hydrocortisone or local corticosteroids.I have had lung inflammation or pneumonitis in the past.I am allergic to penicillin.You have a condition that weakens your immune system from birth.I am fully active or can carry out light work.My organs and bone marrow are functioning well, as tested within the last 10 days.I have had tuberculosis in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment with Adoptive Cell Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment process for this experiment open currently?
"Correct. Per data hosted on clinicaltrials.gov, this medical study is still looking for participants. It was first made available to the public on February 13th 2023 and has been modified as recently as March 2nd of the same year. Only 12 patients are being sought at one site location."
Answered by AI
What is the upper limit on enlistment for this clinical trial?
"Affirmative. Clinicaltrials.gov's records indicate that the trial was initially announced on February 13th, 2023 and has since been updated on March 2nd, 2023. This medical experiment requires 12 participants across a single site to be recruited."
Answered by AI
Has the FDA sanctioned Adoptive Cell Therapy as a viable treatment?
"Treatment with Adoptive Cell Therapy is thought to have a safety rating of 1, as there are only limited existing data points that can suggest efficacy and patient safety."
Answered by AI
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