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

NCT ID: NCT05096234

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2023-10-09

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.

Conditions

Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[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

Group Type: EXPERIMENTAL

[ 18F]F-AraG PET

Intervention Type: DRUG

Dose: 5 mCi (±10%) Mode of Administration: Intravenous (IV)

Interventions

[ 18F]F-AraG PET

Dose: 5 mCi (±10%) Mode of Administration: Intravenous (IV)

Intervention Type: DRUG

Other Intervention Names

[ 18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D- arabinofuranosylguanine; trade name VisAcT)

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:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CellSight Technologies, Inc.

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Miklos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University, School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

CCT5038

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-56655

Identifier Type: -

Identifier Source: org_study_id