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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

Must not have

Patients with active systemic infections requiring intravenous antibiotics within 1 week prior to enrollment

Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (other than stable atrial fibrillation)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I have a high-grade bladder cancer but haven't had muscle invasion, and I'm fit for participation.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't needed IV antibiotics for infections in the last week.

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I do not have any severe illnesses like heart failure or unstable heart conditions.

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I have used cancer treatments that affect immune cells before.

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I have not had bladder chemotherapy in the last 6 months.

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I have had lung inflammation or pneumonitis in the past.

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I have had tuberculosis in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety of Adoptive Cell Therapy with TILs

Secondary study objectives

Overall Response Rate

Progression Free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 8Eligibility criteria met