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

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ClinicalTrials.gov Identifier: NCT05096234
Recruitment Status : Recruiting
First Posted : October 27, 2021
Last Update Posted : October 27, 2021
Sponsor:
Collaborator:
CellSight Technologies, Inc.
Information provided by (Responsible Party):
David Miklos, Stanford University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: [ 18F]F-AraG PET Phase 2

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of [18F]F-AraG PET Imaging to Evaluate Immunological Response to Chimeric Antigen Receptor (CAR) T Cell Therapy in Lymphoma
Actual Study Start Date : September 28, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: [18F]F-AraG PET

Subjects will undergo PET imaging at the following time points:

  • Baseline, prior to lymphodepleting chemotherapy: [18F]F-AraGPET/CT, followed the next day by FDG-PET/CT

  • At peak CAR expansion: Day 4 (± 2 days) post-CAR infusion:

    [18F]F-AraG PET

  • At Day +28 (± 4 days) post-CAR infusion: FDG-PET/CT Subjects will have a paired biopsy after each imaging time point, if possible. Subjects will be followed for safety of [18F]F-AraG for 30 days after last dose
 Drug: [ 18F]F-AraG PET
Dose: 5 mCi (±10%) Mode of Administration: Intravenous (IV)
Other Name: [ 18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D- arabinofuranosylguanine; trade name VisAcT)


Outcome Measures
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Primary Outcome Measures :
  1. Primary outcome measure [ Time Frame: values obtained on Day 0 and Day 4 (± 2 days) ]
    Spearman correlation between changes in SUV in [18F]F-AraG signal on PET imaging to changes in T-cell infiltrates in biopsy samples


Other Outcome Measures:
  1. First exploratory outcome measure [ Time Frame: ≥ 3 months ]
    correlation between changes in SUV [18F]F-AraG signal on PET imaging to the observed clinical benefit rate using RECISTv1.1 criteria.

  2. Second exploratory outcome measure [ Time Frame: ≥ 3 months ]
    Correlation between changes in [18F]F-AraG signal to the frequency and grade of two common CAR T cell toxicities, cytokine release syndrome (CRS) and neurotoxicity, if observed in this study population.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old

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

    • DLBCL not otherwise specified; T cell/histiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein Barr virus (EBV)+ DLBCL of the elderly; OR
    • primary mediastinal (thymic) large B cell lymphoma
    • transformation of follicular lymphoma, marginal zone lymphoma or chronic lymphocytic leukemia to DLBCL will also be included

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

    • At least one measureable lesion away from head & neck, liver, kidneys, GI tract and bladder
    • At least one biopsy-accessible lesion or lymph node.
  • Express willingness to undergo low risk FNA or core biopsy of subcutaneous accessible lesion or lymph node.
  • Scheduled to receive commercial or research CAR T cell therapy with axicabtagene ciloleucel (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 < 1.6 mg/dL
    2. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5x upper 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 be eligible for this study

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 with assessment of safety or efficacy, be unable to tolerate additional radiation, or be unlikely to complete all protocol-required visits and procedures.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05096234


Contacts
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Contact: Maria Iglesias 650-723-4247 mariaigl@stanford.edu

Locations
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United States, California
Stanford University, School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Maria Iglesias       mariaigl@stanford.edu   
Principal Investigator: David Miklos         
Sponsors and Collaborators
Stanford University
CellSight Technologies, Inc.
Investigators
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Principal Investigator: David Miklos, MD, PhD Stanford University
More Information
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Responsible Party: David Miklos, Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy), Stanford University
ClinicalTrials.gov Identifier: NCT05096234    
Other Study ID Numbers: IRB-56655
CCT5038 ( Other Identifier: OnCore )
First Posted: October 27, 2021    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases