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CAR T-cell Therapy

Adoptive T Cell Therapy for Melanoma

Phase 1

Recruiting

Led By Michael Nishimura, PhD

Research Sponsored by Loyola University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a diagnosis of metastatic melanoma which is evaluable either clinically or radiologically.

Patients must be 18 years of age or older.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Study Summary

This trial is to see if a new cancer therapy is effective and to what degree. The therapy uses the patient's own cells that are modified with a new gene.

Who is the study for?

Adults with advanced melanoma that can be measured, who are in good physical condition (ECOG PS of 0 or 1), and have tried certain treatments without success. They must not be pregnant, vulnerable individuals, or have severe infections or other health conditions that could interfere with the trial.Check my eligibility

What is being tested?

This Phase I trial is testing escalating doses of genetically modified T cells to treat advanced melanoma. It's funded by the NCI and aims to find the right dose for Phase II trials. Participants receive a retrovirus-modified version of their own T cells.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever, fatigue, and flu-like symptoms; possible organ inflammation; and complications from cell infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My melanoma has spread and can be measured by tests or seen on scans.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I had anti-CTLA-4 treatment over 6 weeks ago and my cancer has since gotten worse.

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My melanoma is positive for tyrosinase and HLA-A2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Approximately 18 patients with Grade 2 through Grade 5 Adverse Events that are related to study drug, graded according to NCI CTCAE Version 4.0

Secondary outcome measures

Audiologic changes of Grade 2 or higher as related to study drug, graded according to NCI CTCAE Version 4.0

Physical Examination

Immunologic changes in T cell count

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Escalating DosesExperimental Treatment1 Intervention

Three patients will be treated at the first & each subsequent dose level. Patients will be observed for 30 days post T cell infusion. If there was one DLT in the first 3 patients, an additional 3 patients will be treated at that level. If no additional DLTs are observed (for a total of 1 DLT in 6 patients) then the dose will be escalated. If two patients in the first 3 patients at a dose level experience a DLT, the dose will be de-escalated to the previous level & an additional 3 patients will be enrolled at that level if 6 have not yet been treated at that level. The maximum tolerated dose (MTD) is defined as the highest dose at which 0 or 1 patient in six has experienced a DLT. If 2 or 3 patients in the first 3 patients experience a DLT at the first dose level, the study will terminate.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,423 Total Patients Enrolled

557 Trials studying Melanoma

193,172 Patients Enrolled for Melanoma

Loyola UniversityLead Sponsor

156 Previous Clinical Trials

30,916 Total Patients Enrolled

2 Trials studying Melanoma

144 Patients Enrolled for Melanoma

Michael Nishimura, PhDPrincipal Investigator - Loyola University

Loyola University

1 Previous Clinical Trials

14 Total Patients Enrolled

1 Trials studying Melanoma

14 Patients Enrolled for Melanoma

Media Library

Autologous TIL 1383I TCR Gene Modified T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02870244 — Phase 1

Melanoma Research Study Groups: Escalating Doses

Melanoma Clinical Trial 2023: Autologous TIL 1383I TCR Gene Modified T Cells Highlights & Side Effects. Trial Name: NCT02870244 — Phase 1

Autologous TIL 1383I TCR Gene Modified T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02870244 — Phase 1

Frequently Asked Questions

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

How many participants are necessary for this clinical trial to reach its goals?

"Affirmative. According to information available on the clinicaltrials.gov website, this trial is actively recruiting participants and has been since February 1st 2015 with its last update in March 8th 2018. As of now, 18 individuals need to be enrolled for only one location."

Answered by AI

What qualifiers should a potential participant of this trial meet?

"This trial is seeking 18 individuals with metastatic melanoma aged between 18 and 89. Essential qualifications include: having a clinically or radiologically determinable diagnosis of melonama, being able to provide informed consent, having an ECOG performance status of 0 or 1, possessing tyrosinase-positive/ HLA-A2 positive pathologic review from biopsy results, displaying cardiac ejection fraction greater than 50%, not receiving CTLA4 treatment for at least 6 weeks prior to enrollment nor PD1 blockade/PDL1 antibody therapy for 4 weeks before commencement of the study, and presenting V600E mutation that has failed approved BRA"

Answered by AI

Is enrollment currently available for this study?

"Yes, the information posted on clinicaltrials.gov confirms that this trial is currently in search of volunteers. The study was first advertised on February 1st 2015 and its entry most recently updated on March 8th 2018. A total of 18 participants are needed at one medical site to complete the research project."

Answered by AI

Is eligibility for this clinical experiment restricted to those under the age of 55?

"This trial requires participants to be between 18 and 89 years of age. There are 52 clinical trials open for those under the legal threshold, whilst 741 studies accept enrollees aged 65 or above."

Answered by AI

Has the FDA sanctioned Escalating Doses for therapeutic use?

"Our team at Power assigned Escalating Doses a score of 1 due to the limited amount of data available regarding its efficacy and safety, as this is only a Phase 1 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes

Michael Nishimura 2015. "Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02870244.

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