TCR Genetically Engineered PBMC and PBSC After Melphalan Conditioning Regimen in Treating Participants With Relapsed and Refractory Multiple Myeloma

Summary

This phase I trial studies the side effects of NY-ESO-1 TCR engineered peripheral blood mononuclear cells (PBMC) and peripheral blood stem cells (PBSC) after melphalan conditioning regimen in treating participants with multiple myeloma that has come back or does not respond to treatment. The melphalan 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. Giving NY-ESO-1 TCR PBMC and PBSC after melphalan may work better at treating multiple myeloma.

Conditions

• HLA-A*0201 Positive Cells Present
• NY-ESO-1 Positive Tumor Cells Present
• Recurrent Plasma Cell Myeloma
• Refractory Plasma Cell Myeloma

Interventions

RADIATION

18F-FHBG

Given IV

BIOLOGICAL

Aldesleukin

Given SC

BIOLOGICAL

Cellular Therapy

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

PROCEDURE

Computed Tomography

Undergo PET/CT

BIOLOGICAL

Filgrastim

Given SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Lenalidomide

Given PO

PROCEDURE

Leukapheresis

Undergo leukapheresis

DRUG

Melphalan

Given IV

DRUG

Plerixafor

Given SC

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Sponsors & Collaborators

• Novartis Pharmaceuticals

  collaborator INDUSTRY

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Sarah Larson, M.D. · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-10

Primary Completion

2019-06-25

Completion

2019-06-25

FDA Drug

Yes

Countries

• United States

Study Locations