Clinical trial NCT05096234: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: CellSight Technologies, Inc.
First posted: 2021-10-27
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Primary outcome measure
timeFrame: values obtained on Day 0 and Day 4 (± 2 days)
Secondary outcomes:
Other outcomes:
measure: First exploratory outcome measure
timeFrame: ≥ 3 months
measure: Second exploratory outcome measure
timeFrame: ≥ 3 months
Locations:
city: Stanford
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: David Miklos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: