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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
Must not have
Untreated brain metastases
Active autoimmune disease requiring immunosuppressive therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post infusion
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how well lab-modified immune cells work in treating advanced Merkel cell cancer. The treatment aims to improve the body's ability to fight the cancer by enhancing the immune cells.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have brain metastases that have not been treated.
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I am on medication for an autoimmune disease.
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I had a severe reaction to previous immunotherapy.
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I currently have an infection that isn't under control.
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I have had a kidney or another solid organ transplant.
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I am taking more than 10 mg of prednisone or its equivalent daily.
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I am not using any experimental treatments or therapies for MCC.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Overall survival
Progression-free survival

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: 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
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2017
Completed Phase 2
~2440
Pembrolizumab
2017
Completed Phase 3
~2810
Interferon Gamma-1b
2013
Completed Phase 2
~50

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for skin conditions often involve immune modulation to enhance the body's ability to fight disease. For example, topical immunotherapy agents like DPCP and SADBE are used to treat alopecia areata by inducing a mild allergic reaction that stimulates hair regrowth. Similarly, gene-modified immune cells, such as FH-MCVA2TCR, are designed to enhance the immune response against cancer cells in Merkel cell cancer. These treatments matter for patients with other skin conditions because they represent a shift towards harnessing the body's immune system to target and treat diseases, potentially offering more effective and personalized therapeutic options.
What kind of rash is it?: deciphering the dermatologic toxicities of biologic and targeted therapies.

Find a Location

Who is running the clinical trial?

Affini-T TherapeuticsUNKNOWN
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
147,987 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
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