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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05096234
Other study ID # IRB-56655
Secondary ID CCT5038
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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