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

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 30, 2022

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.

OUTLINE:

Prior to CAR T-cell therapy, patients receive 18F-FAZA intravenously (IV). Beginning 2 hours after injection, patients undergo PET scan over 30-45 minutes.

After completion of study, patients are followed up for up to 6 months after CAR T-cell therapy.

Interventions

  • Radiation: Fluorine F 18-fluoroazomycin Arabinoside
    • Given IV
  • Procedure: Positron Emission Tomography
    • Undergo PET scan

Arms, Groups and Cohorts

  • Diagnostic (18F-FAZA PET scan)
    • Prior to CAR T-cell therapy, patients receive 18F-FAZA IV. Beginning 2 hours after injection, patients undergo PET scan over 30-45 minutes.

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of fluorine F 18-fluoroazomycin arabinoside (18F-FAZA) positron emission tomography (PET) scans with positive hypoxic volume (HV)
    • Time Frame: After completion of one-time 18FFAZA PET scan, 1 day
    • Will calculate the uniformly minimum-variance unbiased estimator, p-value and 95% confidence interval (CI) for the response rates.

Secondary Measures

  • Overall response (OR)
    • Time Frame: At 30, 90, and 180 days after chimeric antigen receptor (CAR) T-cell therapy, up to 6 months
    • Will determine OR at any time point as attainment of either complete response (CR) or partial response (PR). Logistic regressions will be used to evaluate the association between OR and intratumoral hypoxia, where hypoxia is analyzed as a binary and a continuous covariate.

Participating in This Clinical Trial

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
  • Planned 18F-FDG PET scan before receipt of CAR T-cell therapy
  • 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
  • Body weight over 300 pounds (precluding use of PET scanner)
  • Pregnancy or active lactation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, San Francisco
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • C. Babis Andreadis, MD, Principal Investigator, UCSF Medical Center-Mount Zion

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