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CAR T-cell Therapy

Gene-Modified T Cells for Advanced Cancers

Phase 1 & 2
Waitlist Available
Led By Philip McCarthy, MD
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with solid tumors meeting specific criteria for inoperable or metastatic melanoma, ovarian, primary peritoneal or fallopian tube carcinoma, synovial sarcoma, or other histologies
Patients must meet specific treatment history criteria for each tumor type
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of gene-modified T cells, given with or without decitabine, to treat patients with malignancies expressing cancer-testis antigens 1 (NY-ESO-1) gene that have spread to other places in the body (advanced).

Who is the study for?
This trial is for patients with advanced cancers like melanoma, ovarian, peritoneal or fallopian tube carcinoma, and synovial sarcoma that express the NY-ESO-1 gene. Participants need available tissue for testing or agree to a biopsy, have a caregiver nearby, meet medical criteria, use birth control, understand the study's nature and consent to it. They must not have brain metastases or severe autoimmune diseases.Check my eligibility
What is being tested?
The trial tests gene-modified T cells with/without decitabine in treating advanced malignancies expressing NY-ESO-1. It aims to find out how well these treatments work and their best doses by modifying patients' T cells to target tumor cells better.See study design
What are the potential side effects?
Potential side effects include immune reactions due to modified T cells targeting cancerous tissues; chemotherapy-related issues such as fatigue, nausea; risk of infection; possible adverse reaction from decitabine including blood disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is inoperable or has spread and falls into one of the specified categories.
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My treatment history matches the specific requirements for my type of cancer.
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My veins are suitable for apheresis.
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I can provide a tissue sample for NY-ESO-1 testing or am willing to have a biopsy.
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I am eligible for a second transgenic T cell infusion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Dose Limiting Toxicities
Number of Participants With Feasibility Concerns in Manufacturing of NY-ESO-1/ dnTGFbetaRII Engineered Cells
Secondary outcome measures
Expression of the NY-ESO-1 T Cell Receptor (TCR) Transgenic Protein in Peripheral Blood Mononuclear Cells (PBMC)
Replication Competent Retrovirus (RCR)
Tumor Response (Complete and Partial Response)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort II (decitabine, cyclophosphamide, TCR/dnTGFbetaRII)Experimental Treatment5 Interventions
Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Group II: Cohort I (cyclophosphamide, TCR/dnTGFbetaRII)Experimental Treatment4 Interventions
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2004
Completed Phase 3
~1680
Cyclophosphamide
1995
Completed Phase 3
~3780
Leukapheresis
2010
Completed Phase 2
~640

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
397 Previous Clinical Trials
30,499 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,606 Previous Clinical Trials
40,913,469 Total Patients Enrolled
Philip McCarthy, MDPrincipal InvestigatorRoswell Park Cancer Institute
1 Previous Clinical Trials
31 Total Patients Enrolled

Media Library

Gene-Modified T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02650986 — Phase 1 & 2
Cancer Research Study Groups: Cohort II (decitabine, cyclophosphamide, TCR/dnTGFbetaRII), Cohort I (cyclophosphamide, TCR/dnTGFbetaRII)
Cancer Clinical Trial 2023: Gene-Modified T Cells Highlights & Side Effects. Trial Name: NCT02650986 — Phase 1 & 2
Gene-Modified T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02650986 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been any other explorations into the effects of TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes?

"Currently, there are 909 clinical trials examining the efficacy of TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes. Of those studies, 165 have reached phase 3 and 29294 sites across America are conducting research related to this treatment. The majority of these experiments take place in Philadelphia, Pennsylvania."

Answered by AI

Is it still possible for individuals to seek inclusion in this trial?

"This investigation is no longer inviting participants; the trial was first published on July 14th 2017 and last updated on May 31st 2022. For those hoping to join another medical study, 4035 studies are currently enrolling patients with malignant neoplasm of ovary and 909 clinical trials are accepting candidates for TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes."

Answered by AI

To what maladies does TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes typically provide relief?

"Multiple sclerosis is often remedied through the use of Transforming Growth Factor Beta-Dependent Negative Regulator II (TGFbDNRII)-transduced Autologous Tumor Infiltrating Lymphocytes. Besides MS, this treatment has been proven beneficial for a variety of other ailments such as leukemia, myelocytic, acute and retinoblastoma, in addition to histiocytic lymphoma."

Answered by AI

What is the overall participant count for this medical experiment?

"At the present moment, this research study is not enrolling any new participants. The trial was opened on July 14th 2017 and last amended on May 31st 2022; if you are looking for alternatives, there are 4035 clinical trials currently accepting patients with malignant neoplasms of ovary and 909 studies recruiting TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes."

Answered by AI

What is the anticipated outcome of this experiment?

"The primary purpose of this clinical trial is to evaluate the manufacturability of NY-ESO-1/ dnTGFbetaRII engineered cells over a period of approximately one month. Secondary endpoints are tumor response (complete and partial) measured through Response Evaluation Criteria in Solid Tumors (RECIST 1.1), expression levels of NY-ESO-1 transgenic protein present in peripheral blood mononuclear cells at various points during the study, as well as an assessment done every 3 months for the first year and then every 6 to 12 months thereafter."

Answered by AI
~2 spots leftby Mar 2025