Adoptive Cell Therapy for Melanoma (ACT Trial)

Phase 1

Recruiting

Research Sponsored by AgonOx, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 2, 4, 8, and 12 weeks after cell infusion, then per pi discretion

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at using selected autologous cells from a patient's tumor to treat late-stage cancer. The cells are expanded, then delivered intravenously. It is hoped they will be more effective in treating cancer.

Who is the study for?

Adults over 18 with advanced solid tumors that are metastatic or unresectable, and have progressed after standard therapy. They must have a tumor large enough for cell extraction and meet specific blood, liver, and kidney function criteria. Women of childbearing age must avoid pregnancy during the trial.

What is being tested?

The study tests adoptive cell therapy using autologous CD8+ TIL (tumor infiltrating lymphocytes) selected for their cancer-fighting potential in patients with various solid tumors. Patients will receive an infusion of these cells along with low-dose IL-2 to enhance treatment efficacy.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as inflammation in different body parts, fatigue, flu-like symptoms due to IL-2 administration, and complications from intravenous infusions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks after cell infusion, then per pi discretion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks after cell infusion, then per pi discretion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after cell infusion, then per pi discretion for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety of DP CD8 TIL

Secondary study objectives

Compare persistence of DP CD8 TIL and DP CD8 TIL KD in peripheral blood

Efficacy of DP CD8 TIL

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: DP CD8 TIL KDExperimental Treatment2 Interventions

Adoptive Cell Transfer of tumor infiltrating lymphocytes that were selected for tumor reactivity by the expression of cell surface proteins CD39 and CD103 and expanded in vitro in the presence of PH-762, a silencing RNA that reduces the expression of the checkpoint inhibitor PD-1. A suspension of 1-40 billion cells will be delivered one time by intravenous infusion.

Group II: DP CD8 TILExperimental Treatment2 Interventions

Adoptive Cell Transfer of tumor infiltrating lymphocytes that were selected for tumor reactivity by the expression of cell surface proteins CD39 an CD103 and expanded in vitro. A suspension of 1-40 billion cells will be delivered one time by intravenous infusion.

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