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

NCT05096234 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: IRB-56655CCT5038
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

  values obtained on Day 0 and Day 4 (± 2 days)

Other Outcomes (2)

• First exploratory outcome measure

  ≥ 3 months

• Second exploratory outcome measure

  ≥ 3 months

Study Arms (1)

[18F]F-AraG PET

EXPERIMENTAL

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

Interventions

[ 18F]F-AraG PET DRUG

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

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

[18F]F-AraG PET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• CellSight Technologies, Inc.: collaborator

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• David Miklos, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 27, 2021
• Study Start: September 28, 2021
• Primary Completion: May 9, 2022
• Study Completion: October 9, 2023
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)