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CAR T-cell Therapy

Genetically Engineered Lymphocytes for Melanoma

Phase 1

Waitlist Available

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

The patients BRAF mutation status at position 600 must be known prior to enrollment. Patients with V600E mutations are eligible if they have failed Vemurafenib therapy or have been offered Vemurafenib therapy and refused.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Study Summary

This trial is testing if it is safe to deliver genetically engineered lymphocytes to patients with metastatic melanoma.

Who is the study for?

Adults with metastatic melanoma that can be measured, who are in good physical condition (ECOG PS 0 or 1), and have specific genetic markers (HLA-A2 positive, tyrosinase positive). They must not be pregnant, have had certain treatments recently, or suffer from severe systemic diseases. Prior immunotherapies are allowed except for Tyrosinase immunotherapy.Check my eligibility

What is being tested?

This phase one trial is testing the safety of different doses of genetically engineered lymphocytes to treat patients with advanced melanoma. The study will progressively test four increasing dose levels to find a safe dosage.See study design

What are the potential side effects?

As this is an early-phase trial focusing on safety, exact side effects aren't listed but may include typical immune-related reactions such as fever, fatigue, allergic responses or potentially more serious organ-specific inflammation.

Eligibility Criteria

Inclusion Criteria

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

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I know my cancer's BRAF status and have either failed or refused Vemurafenib therapy.

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My melanoma has spread and can be measured by tests or exams.

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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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My melanoma is positive for tyrosinase and HLA-A2.

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My heart pumps well, with an ejection fraction over 50%.

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

Find dose of autologous T cell receptor

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose 4Experimental Treatment1 Intervention

Subjects will then receive a single infusion of autologous bulk TIL 1383I TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 1383I TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4+ and CD8+ T cells expressing the TIL 1383I TCR. Subjects in cohort 4 will receive 7.5 x 107 TIL 1383I TCR transduced T cells per kg body weight.

Group II: Dose 3Experimental Treatment1 Intervention

Subjects in cohort 3 will receive 2.5 x 107 TIL 1383I TCR transduced T cells per kg body weight.

Group III: Dose 2Experimental Treatment1 Intervention

cohort 2 will receive 7.5 x 106 TIL 1383I TCR transduced T cells per kg body weight.

Group IV: Dose 1Experimental Treatment1 Intervention

Subjects in cohort 1 will receive 2.5 x 106 TIL 1383I TCR transduced T cells per kg body weight

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dose 4

2014

Completed Phase 1

~70

Dose 2

2015

Completed Phase 1

~90

Dose 3

2014

Completed Phase 1

~70

Dose 1

2015

Completed Phase 1

~90

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Loyola UniversityLead Sponsor

156 Previous Clinical Trials

30,920 Total Patients Enrolled

2 Trials studying Melanoma

148 Patients Enrolled for Melanoma

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,139 Total Patients Enrolled

557 Trials studying Melanoma

193,219 Patients Enrolled for Melanoma

Michael Nishimura, PhDPrincipal InvestigatorLoyola University Chicago

1 Previous Clinical Trials

18 Total Patients Enrolled

1 Trials studying Melanoma

18 Patients Enrolled for Melanoma

Media Library

Dose 1 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01586403 — Phase 1

Melanoma Research Study Groups: Dose 1, Dose 2, Dose 3, Dose 4

Melanoma Clinical Trial 2023: Dose 1 Highlights & Side Effects. Trial Name: NCT01586403 — Phase 1

Dose 1 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01586403 — Phase 1

Frequently Asked Questions

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

Is this study welcoming new participants?

"Unfortunately, the clinical trial hosted on clinicaltrials.gov is no longer recruiting participants. Initially posted in July 2012 and most recently updated in October 2020, this study has since been exhausted of candidates; however there are many other trials requesting enrollment at present."

Answered by AI

Has the FDA sanctioned Dose 2 for use?

"Our evaluation of Dose 2's safety has been scored at a 1, due to the scarcity of data attesting to its efficacy and minimal research conducted on its risk profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transfer of Genetically Engineered Lymphocytes in Melanoma Patients

Michael Nishimura 2012. "Transfer of Genetically Engineered Lymphocytes in Melanoma Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01586403.

All > Melanoma