18F-F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma

Last updated: February 3, 2025
Sponsor: Stanford University
Overall Status: Terminated

Phase

1

Condition

Lymphoma

Non-hodgkin's Lymphoma

Leukemia

Treatment

[ 18F]F-AraG PET

Clinical Study ID

NCT05096234
IRB-56655
CCT5038
  • Ages > 18
  • All Genders

Study Summary

This is a pilot study in adult subjects with aggressive B-cell lymphoma who will receive commercial or research CAR T cell therapy as anticancer treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years old

  • Histologically confirmed aggressive B cell NHL including the following types definedby WHO 2008:

  • DLBCL not otherwise specified; T cell/histiocyte rich large B cell lymphoma;DLBCL associated with chronic inflammation; Epstein Barr virus (EBV)+ DLBCL ofthe elderly; OR

  • primary mediastinal (thymic) large B cell lymphoma

  • transformation of follicular lymphoma, marginal zone lymphoma or chroniclymphocytic leukemia to DLBCL will also be included

  • Measurable disease by PET imaging (as defined by Cheson (2014)), that meets all thefollowing criteria:

  • At least one measureable lesion away from head & neck, liver, kidneys, GI tractand bladder

  • At least one biopsy-accessible lesion or lymph node.

  • Express willingness to undergo low risk FNA or core biopsy of subcutaneousaccessible lesion or lymph node.

  • Scheduled to receive commercial or research CAR T cell therapy with axicabtageneciloleucel (Yescarta ®) as part of anticancer therapy.

  • Adequate renal and hepatic function, defined as:

  1. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min or Cr < 1.6mg/dL

  2. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5xupper limit of normal (ULN)

  3. Total bilirubin ≤ 1.5 mg/dL, except in cases of Gilbert's syndrome

  • Able to give informed consent. Subjects unable to give informed consent will not beeligible for this study

Exclusion

Exclusion Criteria:

  • Women who are pregnant or breastfeeding.

  • Subjects with significant GI disease involvement by PET imaging

  • In the investigator's judgment, have any medical condition likely to interfere withassessment of safety or efficacy, be unable to tolerate additional radiation, or beunlikely to complete all protocol-required visits and procedures.

Study Design

Total Participants: 2
Treatment Group(s): 1
Primary Treatment: [ 18F]F-AraG PET
Phase: 1
Study Start date:
September 28, 2021
Estimated Completion Date:
October 09, 2023

Study Description

Primary Objectives:

  • Explore the relationship of change in [18F]F-AraG PET signal following CAR T cell treatment with changes in T cell infiltration in tumor biopsies.

Exploratory Analyses:

  • Explore the relationship of change in [18F]F-AraG PET signal in tumor lesions following CAR T cell treatment with clinical benefit rate (defined as Complete Response (CR) + Partial Response (PR) + stable disease (SD) ≥ 3 months) using RECISTv1.1 criteria

  • Correlate the change in [18F]F-AraG PET signal in tumor lesions following CAR T cell therapy with maximum grade of Cytokine Release Syndrome (CRS) and neurotoxicity experienced.

Connect with a study center

  • Stanford University, School of Medicine

    Stanford, California 94305
    United States

    Site Not Available

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