NCT02774291

Anti-NY ESO-1 mTCR Peripheral Blood Lymphocytes

Pilot Study of Adoptive Cell Transfer for the Treatment of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Anti-NY ESO-1 Murine TCR-Gene Engineered Lymphocytes

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 66 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety and tolerability of the administration of anti-ESO (cancer/test antigen) mTCR (T cell receptor)-engineered peripheral blood lymphocytes (anti-thyroglobulin mTCR-transduced autologous peripheral blood lymphocytes) plus high-dose aldesleukin following a nonmyeloablative lymphoid depleting preparative regimen in human leukocyte antigen (HLA)-A2 positive patients with metastatic cancer expressing the ESO antigen. SECONDARY OBJECTIVES: I. Determine the in vivo survival of T-cell receptor (TCR) gene-engineered cells. II. Determine the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. OUTLINE: Patients receive standard cyclophosphamide intravenously (IV) over 1 hour on days -7 to -6 and fludarabine phosphate via intravenous piggy back (IVPB) over 30 minutes on days -5 to -1 followed by anti-ESO (cancer/test antigen) mTCR-transduced autologous peripheral blood lymphocytes IV over 20-30 minutes on day 0 and aldesleukin IV over 15 minutes approximately every 8 hours on days 0-4. Patients also receive filgrastim subcutaneously (SC) on days 1-4. After completion of study treatment, patients are followed up at 6 weeks, annually for 5 years, and then periodically for 10 years thereafter.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-04-20
• Primary completion: 2020-07-01
• Completion: 2020-08-04
• First posted: 2016-05-17
• Last updated: 2023-08-04
• Results posted: 2023-08-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study