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A Phase I/II Study of Gene-modified WT1 TCR Therapy in MDS & AML Patients

NCT02550535 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-10-02

No results posted yet for this study

Summary

This is a Phase I/II trial to determine safety, clinical efficacy and feasibility of a gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML).

Patient's white blood cells (T cells) will be modified by transferring a gene which enables them to make a new T cell receptor (TCR) that can recognize fragments of a protein called WT1 (Wilms' tumour 1) which is present at abnormally high levels on the surface of myelodysplastic and leukaemic cells.

In this trial, approximately 25 participants with an Human Leukocyte Antigen A2 (HLA-A\*0201) tissue type who have failed to achieve or maintain an IWG defined response following hypomethylating agent therapy will be recruited.

Conditions

  • Myelodysplastic Syndromes (MDS)
  • Acute Myeloid Leukaemia (AML)

Interventions

GENETIC

Autologous WT1 TCR transduced T cells

Gene therapy: Autologous WT1 TCR transduced T cells administered by intravenous infusion

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • Cell Therapy Catapult

    collaborator OTHER

  • Cell Medica Ltd

    lead INDUSTRY

Principal Investigators

  • Emma Morris, MD · University College London Hospitals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Belgium
  • Germany
  • United Kingdom

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 NCT02550535 on ClinicalTrials.gov