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

NCT03747484 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-03-06

Study results available
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Summary

This phase I/II trial studies the side effects of gene-modified immune cells (FH-MCVA2TCR) and to see how well they work in treating patients with Merkel cell cancer that has spread to other parts of the body (metastatic) or that cannot be removed by surgery (unresectable). Placing a gene that has been created in the laboratory into immune cells may improve the body's ability to fight Merkel cell cancer.

Conditions

  • Other Skin

Interventions

BIOLOGICAL

Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR

Given IV

DRUG

Avelumab

Given IV

BIOLOGICAL

Pembrolizumab

Given IV

BIOLOGICAL

Interferon Gamma-1b

Given SC

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Affini-T Therapeutics, Inc.

    collaborator INDUSTRY

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Joshua Veatch · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-03
Primary Completion
2024-01-09
Completion
2024-01-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03747484 on ClinicalTrials.gov