MedTrace Logo

Genetically Engineered PBMC and PBSC Expressing NY-ESO-1 TCR After a Myeloablative Conditioning Regimen to Treat Patients With Advanced Cancer

NCT03240861 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-11-01

No results posted yet for this study

Summary

This phase I clinical trial evaluates the safety and feasibility of administering NY-ESO-1 TCR (T cell receptor)engineered peripheral blood mononuclear cells (PBMC) and peripheral blood stem cells (PBSC) after a myeloablative conditioning regimen to treat patients with cancer that has spread to other parts of the body. The conditioning chemotherapy makes room in the patient?s bone marrow for new blood cells (PBMC) and blood-forming cells (stem cells) to grow. Giving NY-ESO-1 TCR PBMC and stem cells after the conditioning chemotherapy is intended to replace the immune system with new immune cells that have been redirected to attack and kill the cancer cells and thereby improve immune system function against cancer.

Conditions

  • HLA-A*0201 Positive Cells Present
  • Locally Advanced Malignant Neoplasm
  • NY-ESO-1 Positive
  • Unresectable Malignant Neoplasm
  • Sarcoma

Interventions

OTHER

18F-FHBG

Given IV

BIOLOGICAL

Aldesleukin

Given SC

DRUG

Busulfan

Given IV

BIOLOGICAL

Cellular Therapy

Given LV-NYESO TCR/sr39TK PBSC IV and RV-NYESO TCR PBMC IV

PROCEDURE

Computed Tomography

Undergo PET/CT

BIOLOGICAL

Filgrastim

Given SC

DRUG

Fludarabine

Given IV

PROCEDURE

Leukapheresis

Undergo leukapheresis

DRUG

Plerixafor

Given SC

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Sponsors & Collaborators

  • California Institute for Regenerative Medicine (CIRM)

    collaborator OTHER

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Theodore Scott Nowicki, M.D. · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-26
Primary Completion
2023-10-19
Completion
2023-10-19
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 NCT03240861 on ClinicalTrials.gov