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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Refractory Aggressive Non-Hodgkin Lymphoma; Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma; Refractory Plasma Cell Myeloma; Recurrent Diffuse Large B-Cell Lymphoma; Recurrent Malignant Neoplasm; Refractory Diffuse Large B-Cell Lymphoma; Recurrent Aggressive Non-Hodgkin Lymphoma; Refractory High Grade B-Cell Lymphoma; Recurrent High Grade B-Cell Lymphoma; Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma; Recurrent Plasma Cell Myeloma; Refractory Malignant Neoplasm

Treatments: Drug: Fluorine F 18-fluoroazomycin Arabinoside; Procedure: Positron Emission Tomography

Study type: Observational

Funder types: Other

Identifiers

NCT04409314

20921

NCI-2020-03216 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed diagnosis of:

  • Aggressive lymphoma, including: Diffuse large B-cell lymphoma (DLBCL) (including transformed disease), high-grade B-cell lymphoma, or primary mediastinal B-cell lymphoma
  • Multiple myeloma (MM), with imaging within 6 months of enrollment demonstrating >= 1 plasmacytoma measuring >= 5 cm along any axis
  • Other malignancy with radiographically measurable disease

• R/R disease with planned receipt of CAR T-cell therapy at University of California, San Francisco (UCSF), either through an Food and Drug Administration-approved CAR construct or through a separate interventional clinical trial

• Ability to provide informed consent prior to study entry

Exclusion criteria

• Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with participant's safety, provision of informed consent, or compliance with study procedures
• Pregnancy or active lactation

Trial design

23 participants in 1 patient group

Diagnostic (18F-FAZA PET scan)

Description:

Prior to CAR T-cell therapy, patients receive administration of 18F-FAZA IV. Patients will then undergo a vertex-thigh PET scan approximately 2 hours after injection of 18FFAZA lasting 30-45 minutes.

Treatment:

Procedure: Positron Emission Tomography

Drug: Fluorine F 18-fluoroazomycin Arabinoside