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Anti-NY ESO-1 mTCR Peripheral Blood Lymphocytes

NCT02774291 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-08-04

Study results available
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Summary

This pilot clinical trial studies the side effects of anti-ESO (cancer/test antigen) murine T-cell receptor (mTCR)-transduced autologous peripheral blood lymphocytes and combination chemotherapy with cyclophosphamide and fludarabine phosphate in treating patients with cancer that has spread to other places in the body (metastatic) and expresses the gene NY-ESO-1. Donor white blood cells that are treated in the laboratory with anti-cluster of differentiation (CD)3 may help treat metastatic cancer. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Aldesleukin may stimulate white blood cells, including natural killer cells, to kill metastatic cancer cells. Giving anti-ESO (cancer/test antigen) mTCR-transduced autologous peripheral blood lymphocytes together with combination chemotherapy and aldesleukin may kill more cancer cells.

Conditions

  • HLA-A2 Positive Cells Present
  • Metastatic Malignant Neoplasm
  • Metastatic Malignant Neoplasm in the Brain

Interventions

BIOLOGICAL

Aldesleukin

Given IV

BIOLOGICAL

Anti-thyroglobulin mTCR-transduced Autologous Peripheral Blood Lymphocytes

Given IV

DRUG

Cyclophosphamide

Given IV

BIOLOGICAL

Filgrastim

Given SC

DRUG

Fludarabine Phosphate

Given IVPB

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Ira Braunschweig · Albert Einstein College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2020-07-01
Completion
2020-08-04
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 NCT02774291 on ClinicalTrials.gov