Treatment with Adoptive Cell Therapy for Non-Invasive Bladder Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Moffitt Cancer Center, Tampa, FLNon-Invasive Bladder Cancer+1 MoreAdoptive Cell Therapy with Tumor-infiltrating Lymphocytes (TIL) - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will assess a new type of therapy for non-muscle invasive bladder cancer: adoptive cell therapy using TIL.

Eligible Conditions
  • Non-Invasive Bladder Cancer
  • Bladder Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: up to 12 months

Up to 6 months
Safety of Adoptive Cell Therapy with TILs
at 3 months
Overall Response Rate
up to 12 months
Progression Free Survival

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Treatment with Adoptive Cell Therapy
1 of 1

Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Treatment with Adoptive Cell Therapy · No Placebo Group · Phase 1

Treatment with Adoptive Cell Therapy
Biological
Experimental Group · 1 Intervention: Adoptive Cell Therapy with Tumor-infiltrating Lymphocytes (TIL) · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
510 Previous Clinical Trials
126,940 Total Patients Enrolled
United States Department of DefenseFED
790 Previous Clinical Trials
202,711 Total Patients Enrolled
Michael A Poch, MDPrincipal InvestigatorMoffitt Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Participants must demonstrate satisfactory levels of organ and marrow functioning within a 10 day window prior to enrollment as specified in the protocol.
Your physical condition is rated 0-1 on the Eastern Cooperative Oncology Group Performance Status scale.
Patients aged 18 or over with BCG-unresponsive High Grade Non-Muscle Invasive Bladder Cancer (NMIBC) who have undergone complete restaging TURBT to confirm absence of muscle invasion may be eligible for this study, provided they are deemed healthy enough
You have visible evidence of recurrence, as detected by cytoscopy.
You possess the mental capacity and are willing to sign a legally binding agreement confirming your understanding.
The tissue specimen suitable for TIL preparation may be obtained through a procedure already required by the patient, or with consultation from a surgical specialist, a separate and low-risk procedure (e.g

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.