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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.

Must not have

Patients with a history metastatic melanoma involving the brain will be excluded if they have active disease or have had active disease within the prior six months that was not controlled with surgery or radiotherapy.

Patients taking steroids for disease control or pain management

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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%.

Exclusion Criteria

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

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I have not had active brain melanoma or treatment for it in the last 6 months.

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I am taking steroids for my condition or to manage pain.

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I do not have any severe illnesses like uncontrolled high blood pressure or heart disease.

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I have been diagnosed with HIV, HBV, or HCV.

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I have some trouble doing my daily activities on my own.

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I do not have any ongoing infections needing antibiotics.

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I have received immunotherapy along with mild chemotherapy.

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I have received Tyrosinase immunotherapy.

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

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

Primary study objectives

Find dose of autologous T cell receptor

Awards & Highlights

No Placebo-Only Group

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

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 2

2015