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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

Pilot Study of [18F]F-AraG PET Imaging to Evaluate Immunological Response to Chimeric Antigen Receptor (CAR) T Cell Therapy in Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05096234
• Other study ID #: IRB-56655
• Secondary ID: CCT5038
• Status: Recruiting
• Phase: Phase 2
• Start date: September 28, 2021
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: Stanford University
• Contact: Maria Iglesias
• Phone: 650-723-4247
• Email: mariaigl[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• [ 18F]F-AraG PET
Dose: 5 mCi (±10%) Mode of Administration: Intravenous (IV)

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	CellSight Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	First exploratory outcome measure	correlation between changes in SUV [18F]F-AraG signal on PET imaging to the observed clinical benefit rate using RECISTv1.1 criteria.	= 3 months
Other	Second exploratory outcome measure	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.	= 3 months
Primary	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)