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CAR T-cell Therapy

Gene-Modified Immune Cells for Skin Cancer

Phase 1 & 2

Waitlist Available

Led By Joshua Veatch

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

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

Must have

HLA-A*02:01 positive

Metastatic or unresectable MCPyV-associated VP-MCC that has progressed on or after prior treatment with a PD-1 axis immune checkpoint inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year post infusion

Awards & highlights

Study Summary

This trial is testing a gene-modified immune cell to see if it is effective and has manageable side effects in treating patients with metastatic or unresectable Merkel cell cancer.

Who is the study for?

This trial is for adults with Merkel cell cancer that's spread or can't be surgically removed, who've had prior treatment with a PD-1 axis inhibitor but got worse without severe side effects. They must have specific blood and organ function levels, no active autoimmune diseases needing strong meds, no recent other cancer treatments, and not be on high-dose steroids.Check my eligibility

What is being tested?

The study tests gene-modified immune cells (FH-MCVA2TCR) combined with drugs like Avelumab and Pembrolizumab to see if they're safe and effective against advanced Merkel cell cancer. It involves modifying patients' own immune cells in the lab to fight the cancer better.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system being overly activated by the modified cells or drugs used in this trial. This could lead to inflammation in various organs, flu-like symptoms from Interferon Gamma-1b, infusion-related reactions, fatigue, or skin conditions.

Eligibility Criteria

Inclusion Criteria

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

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I am HLA-A*02:01 positive.

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My Merkel cell carcinoma has worsened despite treatment with a PD-1 inhibitor.

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I am 18 years old or older.

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I am 60 or older and my heart's pumping ability is at least 35%.

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I understand the study and can give my consent.

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I can care for myself but may need occasional help.

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My Merkel cell carcinoma cannot be removed by surgery.

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I was treated with a PD-1 inhibitor and my cancer progressed without severe side effects.

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My Merkel cell carcinoma is confirmed to be virus-positive.

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My cancer is MCPyV positive.

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I experience mild or no shortness of breath.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year post infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year post infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best overall response

Incidence of adverse events grade 3 or higher determined to be possibly, probably or definitely secondary to any of the study treatments

Secondary outcome measures

Overall survival

Progression-free survival

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment 2 (TCR-T cells, avelumab or pembrolizumab)Experimental Treatment4 Interventions

Approximated 5-7 days prior to receiving FH-MCVA2TCR T-cells, patients receive interferon gamma administered at the FDA-approved dosing of 50mcg/m2, 3 times weekly for a total of 4 weeks. Patients receive FH-MCVA2TCR T-cells IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells.

Group II: Treatment (TCR-T cells, avelumab or pembrolizumab)Experimental Treatment4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Avelumab

2018

Completed Phase 2

~2450

Pembrolizumab

2017

Completed Phase 2

~2010

Interferon Gamma-1b

2013

Completed Phase 2

~50

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Affini-T TherapeuticsUNKNOWN

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

148,238 Total Patients Enrolled

Affini-T Therapeutics, Inc.Industry Sponsor

2 Previous Clinical Trials

124 Total Patients Enrolled

Media Library

FH-MCVA2TCR (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03747484 — Phase 1 & 2

Other Skin Conditions Research Study Groups: Treatment (TCR-T cells, avelumab or pembrolizumab), Treatment 2 (TCR-T cells, avelumab or pembrolizumab)

Other Skin Conditions Clinical Trial 2023: FH-MCVA2TCR Highlights & Side Effects. Trial Name: NCT03747484 — Phase 1 & 2

FH-MCVA2TCR (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03747484 — Phase 1 & 2

Frequently Asked Questions

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

How often is Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR given to patients?

"Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR is most commonly used as a cancer treatment, but can also be used to treat other conditions like unresectable melanoma or disease progression after chemotherapy."

Answered by AI

How many people have been recruited to participate in this clinical trial?

"That is correct. According to the information on clinicaltrials.gov, this study posted on 7/3/2019 and edited most recently on 5/23/2022 is still recruiting patients. They need a total of 16 individuals across 1 site."

Answered by AI

Are researchers still looking for participants for this experiment?

"That is correct, the trial is looking for 16 patients from 1 sites. The posting on clinicaltrials.gov says that the study was first posted on 7/3/2019 and was last updated on 5/23/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer

2019. "Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03747484.