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CAR T-cell Therapy
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
ACT Trial 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.Check my eligibility
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.See study design
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.
ACT Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of DP CD8 TIL
Secondary outcome measures
Compare persistence of DP CD8 TIL and DP CD8 TIL KD in peripheral blood
Efficacy of DP CD8 TIL
ACT 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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Who is running the clinical trial?
Phio Pharmaceuticals Inc.Industry Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
AgonOx, Inc.Lead Sponsor
Phio Pharmaceuticals Corp.UNKNOWN
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: DP CD8 TIL
- Group 2: DP CD8 TIL KD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still open slots in this research endeavor?
"That is correct. Clinicaltrials.gov confirms that this clinical trial, first published on June 1st 2023, is in the process of recruiting subjects. 18 participants are being sought from one medical facility."
Answered by AI
How many individuals are involved in the current experiment?
"Affirmative. The clinical trial's hosting page on clinicaltrials.gov corroborates that the research study is actively recruiting and was first posted June 1st 2023, with updates as recent as June 5th 2023. This trial requires 18 participants from a single medical site to reach completion."
Answered by AI
Has the FDA sanctioned DP CD8 TIL as a legitimate treatment?
"Given the limited data pertaining to DP CD8 TIL's efficacy and safety, our team has assigned a risk score of 1."
Answered by AI
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