NCT04409314

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Fluorine F 18-fluoroazomycin Arabinoside	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET scan

Timeline

• Start date: 2020-04-16
• Primary completion: 2023-08-09
• Completion: 2023-08-09
• First posted: 2020-06-01
• Last updated: 2023-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study