Hypoxia-Specific Imaging to Predict Outcomes of Chimeric Antigen Receptor T-cell Therapy

Recurrent Plasma Cell Myeloma Clinical Trial

Official title: Pilot Study of Hypoxia-Specific Imaging to Predict Outcomes of Chimeric Antigen Receptor T-Cell Therapy

Status Completed

Clinical Trial Summary

This study evaluates whether tumors present in patients with cancer who are planned to get CAR T-cells have low amounts of oxygen (hypoxia). PET scans may be used to check the amounts of oxygen within areas of cancer with a special radioactive tracer called FAZA that specifically looks for areas of low oxygen. This study is being done to help researchers determine how the amount of oxygen within areas of cancer affect how well CAR T-cells kill cancer cells.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To evaluate the incidence of intratumoral hypoxia in patients with relapsed or refractory (R/R) malignancies before treatment with chimeric antigen receptor (CAR) T-cell therapy.

SECONDARY OBJECTIVE:

I. To evaluate the association between intratumoral hypoxia and clinical responses to CAR T-cell therapy.

EXPLORATORY OBJECTIVES:

I. To correlate intratumoral hypoxia with markers of CAR T-cell activity and toxicity.

2. To correlate pre-therapy fluorine F 18-fluoroazomycin arabinoside (18F-FAZA) uptake with pre-therapy 18Ffluorodeoxyglucose (FDG) positron emission tomography (PET) uptake (if available).

OUTLINE:

Prior to CAR T-cell therapy, patients receive 18F-FAZA intravenously (IV). Beginning 2 hours after injection, patients undergo a single PET scan. Patients are followed for up to 6 months after CAR T-cell therapy. ;

Related Conditions & MeSH terms

• Aggression
• Hypoxia
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms
• Neoplasms, Plasma Cell
• Recurrence
• Recurrent Aggressive Non-Hodgkin Lymphoma
• Recurrent Diffuse Large B-Cell Lymphoma
• Recurrent High Grade B-Cell Lymphoma
• Recurrent Malignant Neoplasm
• Recurrent Plasma Cell Myeloma
• Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
• Refractory Aggressive Non-Hodgkin Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma
• Refractory High Grade B-Cell Lymphoma
• Refractory Malignant Neoplasm
• Refractory Plasma Cell Myeloma
• Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma

• NCT number: NCT04409314
• Study type: Observational
• Source: University of California, San Francisco
• Status: Completed
• Start date: April 16, 2020
• Completion date: August 9, 2023