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

Not Recruiting

Trial ID: NCT05096234

Purpose

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.

Official Title

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

Stanford Investigator(s)

David Miklos
David Miklos

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

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.

Intervention(s):

drug: [ 18F]F-AraG PET

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maria Iglesias

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