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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
[ 18F]F-AraG PET
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University, School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F]F-AraG PET

Arm Description

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

Outcomes

Primary Outcome Measures

Primary outcome measure
Spearman correlation between changes in SUV in [18F]F-AraG signal on PET imaging to changes in T-cell infiltrates in biopsy samples

Secondary Outcome Measures

Full Information

First Posted
October 14, 2021
Last Updated
May 15, 2023
Sponsor
Stanford University
Collaborators
CellSight Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05096234
Brief Title
18F-F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma
Official Title
Pilot Study of [18F]F-AraG PET Imaging to Evaluate Immunological Response to Chimeric Antigen Receptor (CAR) T Cell Therapy in Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
CellSight Technologies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
[18F]F-AraG PET
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
[ 18F]F-AraG PET
Other Intervention Name(s)
[ 18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D- arabinofuranosylguanine; trade name VisAcT)
Intervention Description
Dose: 5 mCi (±10%) Mode of Administration: Intravenous (IV)
Primary Outcome Measure Information:
Title
Primary outcome measure
Description
Spearman correlation between changes in SUV in [18F]F-AraG signal on PET imaging to changes in T-cell infiltrates in biopsy samples
Time Frame
values obtained on Day 0 and Day 4 (± 2 days)
Other Pre-specified Outcome Measures:
Title
First exploratory outcome measure
Description
correlation between changes in SUV [18F]F-AraG signal on PET imaging to the observed clinical benefit rate using RECISTv1.1 criteria.
Time Frame
≥ 3 months
Title
Second exploratory outcome measure
Description
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.
Time Frame
≥ 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min or Cr < 1.6 mg/dL Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5x upper limit of normal (ULN) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Iglesias
Phone
650-723-4247
Email
mariaigl@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Miklos, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Iglesias
Email
mariaigl@stanford.edu
First Name & Middle Initial & Last Name & Degree
David Miklos

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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