Genetically Engineered Lymphocytes for Melanoma

Recruiting in Palo Alto (17 mi)

Overseen byMichael Nishimura, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Loyola University

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a phase one trial to determine if genetically engineered lymphocytes can be safely delivered to patients with metastatic melanoma.

Eligibility Criteria

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.

Inclusion Criteria

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

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

I am 18 years old or older.

+7 more

Exclusion Criteria

My melanoma's BRAF V600E mutation status is unknown, or I am responding to or haven't been offered Vemurafenib.

Patients must not be pregnant or nursing because of the potentially harmful effects of these agents on a developing fetus. Women/men of reproductive potential must have agreed to use an effective contraceptive method.

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

+13 more

Participant Groups

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.

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