Non-Hodgkin's LymphomaPhase 1NCT05096234
18F-F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma
A Phase 1 study testing [ 18F]F-AraG PET in people with Non-Hodgkin's Lymphoma, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- [ 18F]F-AraG PET
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2021to 9 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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:
- Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min or Cr < 1.6 mg/dL
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5x upper limit of normal (ULN)
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Stanford, California, 94305
About this study
Official title: Pilot Study of [18F]F-AraG PET Imaging to Evaluate Immunological Response to Chimeric Antigen Receptor (CAR) T Cell Therapy in Lymphoma
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.
Read the 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.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- [ 18F]F-AraG PET
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[ 18F]F-AraG PETDrug
Also called [ 18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D- arabinofuranosylguanine; trade name VisAcT)
Dose: 5 mCi (±10%) Mode of Administration: Intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| [18F]F-AraG PET | Experimental | 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 Receives: Drug: [ 18F]F-AraG PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: values obtained on Day 0 and Day 4 (± 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start28 Sep 2021
- Primary completion9 May 2022
- Study completion9 Oct 2023
Why it stopped: loss of sponsor support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- CellSight Technologies, Inc.
- Responsible party
- Sponsor
- Investigators
- David Miklos, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096234
- Sponsor's protocol ID
- IRB-56655
- Other IDs
- CCT5038
- Status last verified
- Feb 2025
- First submitted
- 14 Oct 2021
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of [18F]F-AraG PET Imaging to Evaluate Immunological Response to Chimeric Antigen Receptor (CAR) T Cell Therapy in Lymphoma
- ClinicalTrials.gov ID
- NCT05096234
- Acronym / sponsor ID
- IRB-56655
- Conditions
- Non-Hodgkin's Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: loss of sponsor support
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- CellSight Technologies, Inc.
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 9 Oct 2023 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]F-AraG PET | Experimental | Drug: [ 18F]F-AraG PETSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years old
- Histologically confirmed aggressive B cell NHL including the following types defined by WHO 2008:
- Measurable disease by PET imaging (as defined by Cheson (2014)), that meets all the following criteria:
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [ 18F]F-AraG PETAlso: [ 18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D- arabinofuranosylguanine; trade name VisAcT)Dose: 5 mCi (±10%) Mode of Administration: Intravenous (IV) | Drug | [18F]F-AraG PET |
Primary outcome
Primary outcome measure
Time frame: values obtained on Day 0 and Day 4 (± 2 days)
Spearman correlation between changes in SUV in [18F]F-AraG signal on PET imaging to changes in T-cell infiltrates in biopsy samples
Results and safety
The study was stopped early (reason given: loss of sponsor support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Miklos, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [ 18F]F-AraG PET in people with Non-Hodgkin's Lymphoma, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: loss of sponsor support). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure (time frame: values obtained on Day 0 and Day 4 (± 2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.