Clinical trial · Interventional
18F-F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma
Pilot Study of [18F]F-AraG PET Imaging to Evaluate Immunological Response to Chimeric Antigen Receptor (CAR) T Cell Therapy in Lymphoma
NCT05096234CI-TRIAL-00085576terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): loss of sponsor support
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [ 18F]F-AraG PET | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]F-AraG PET
- description
- 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
- interventionNames
- Drug: [ 18F]F-AraG PET
Primary outcomes (1)
- measure
- Primary outcome measure
- timeFrame
- values obtained on Day 0 and Day 4 (± 2 days)
- description
- Spearman correlation between changes in SUV in \[18F\]F-AraG signal on PET imaging to changes in T-cell infiltrates in biopsy samples
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.