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Study With T-cel Receptor Gene Therapy in Metastatic Melanoma

NCT02654821 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-11-02

No results posted yet for this study

Summary

Patients with stage IV melanoma (also eye melanoma) will be treated with TCR transduced cells.

Conditions

  • Stage IV Skin Melanoma
  • Eye; Melanoma

Interventions

BIOLOGICAL

TCR transduced T-cells

Eligible patients will undergo leukapheresis to isolate autologous T cells. These T cells will be transduced with a retroviral vector encoding the 1D3 HM CysTCR, and subsequently expanded during short-term ex vivo culture. Following pre-treatment with nonmyeloablative chemotherapy, patients will receive the adoptive transfer of autologous, TCR transduced T cells.

PROCEDURE

Biopsy

During screening, after treatment and at time of regression/progression a biopsy will be taken for translational research.

PROCEDURE

Blood taking

During screening, after the infusion with T-cells, after treatment and at time of regression/progression blood will be taken for translational research.

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • John B.A.G. Haanen, Prof. · Antoni van Leeuwenhoek Ziekenhuis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2019-10-31
Completion
2020-01-31

Countries

  • Netherlands

Study Locations

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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 NCT02654821 on ClinicalTrials.gov