PET Imaging Study of 64Cu-GRIP B for Patients Receiving CD19-directed CAR-T Therapy
NCT ID: NCT06522932
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
32 participants
INTERVENTIONAL
2024-10-23
2027-01-31
Brief Summary
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Detailed Description
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1\. To establish the feasibility of granzyme B detection with 64Cu-GRIP B PET in participants with relapsed/refractory NHL receiving CD19-directed CAR-T cell therapy in both cohorts.
Secondary Objectives:
1. To descriptively report the patterns of intra-tumoral uptake of 64Cu-GRIP B on whole body PET, including by site of disease, uptake by tumor type, inter-tumoral and inter-participant heterogeneity, and tumor-to-background signal in participants with participants with NHL.
2. To descriptively report the number of lesions identified on 64Cu-GRIP B PET compared with conventional imaging in participants with NHL.
3. To assess the safety of 64Cu-GRIP B in participants with NHL undergoing CAR-T cell therapy.
Participants will be initially enrolled in Cohort 1. Based on the interim analysis, enrollment will begin in Cohort 2. An optional research biopsy will be collected after the post-therapy scan and participants will be followed for 12 months after the end of the study intervention.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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Cohort 1: 64Cu-GRIP B PET imaging
Participants with NHL will undergo 64Cu-GRIP B PET before and after CD19-directed CAR-T therapy. Three participants will undergo post-treatment 64Cu-GRIP B PET at the Day 8 time point, three participants will undergo post-treatment 64Cu-GRIP B PET at the Day 15 (+/- 3) time point, and three participants will undergo post-treatment 64Cu-GRIP B PET Day 22 (+/- 3) time point. An optional soft tissue biopsy will be collected following the post-treatment PET. Participants will be followed up for 12 months after the final PET scan.
64Cu-GRIP B
Given IV
Positron Emission Tomography (PET)
Undergo imaging procedure
Optional tumor biopsy
Undergo optional tumor biopsy
Cohort 2: Expansion Phase 64Cu-GRIP B PET imaging
Participants with NHL will undergo 64Cu-GRIP B PET before and after CD19-directed CAR-T therapy with one of the three time points chosen based on 64Cu-GRIP B uptake determined in Cohort 1. An optional soft tissue biopsy will be collected following the post-treatment PET. Participants will be followed up for 12 months after the final PET scan.
64Cu-GRIP B
Given IV
Positron Emission Tomography (PET)
Undergo imaging procedure
Optional tumor biopsy
Undergo optional tumor biopsy
Interventions
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64Cu-GRIP B
Given IV
Positron Emission Tomography (PET)
Undergo imaging procedure
Optional tumor biopsy
Undergo optional tumor biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Histologically-confirmed relapsed/refractory non-Hodgkin lymphoma (NHL) with at least one prior line of therapy.
2. Planned treatment with a commercially available CD19 targeting CAR-T cell product.
2. Willing to undergo post-treatment tumor biopsies and has safely accessible soft tissue lesion.
3. Age \>= 18 years.
4. Ability to understand and the willingness to sign a written informed consent document.
5. Eastern Cooperative Oncology Group (ECOG) performance status \<2 (Karnofsky \>60%).
6. Individuals with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
7. Individuals with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
8. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. The effects of 64Cu-GRIP B on the developing human fetus are unknown. For this reason, participants of childbearing potential must agree to use adequate contraception: all participants should use barrier protection for the duration of study participation and for one month after last administration of study intervention. Should a participant become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Male participants treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and one month after last administration of study treatment.
Exclusion Criteria
2. Pregnant participants are excluded from this study because the effects of 64Cu-GRIP B on the developing human fetus are unknown. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing parent with 64Cu-GRIP B, breastfeeding should be discontinued if the nursing parent receives 64Cu-GRIP B.
3. Hypersensitivity to 64Cu-GRIP B or any of its excipients.
18 Years
ALL
Yes
Sponsors
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The V Foundation
OTHER
Michael Randall
OTHER
Responsible Party
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Michael Randall
Principal Investigator
Principal Investigators
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Randall Michael, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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UCSF Hematopoietic Malignancies Clinical Trial Recruitment
Role: CONTACT
Phone: 877-827-3222
Email: [email protected]
Facility Contacts
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UCSF Hematopoietic Malignancies Clinical Trial Recruitment
Role: primary
Role: backup
Other Identifiers
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NCI-2024-05085
Identifier Type: REGISTRY
Identifier Source: secondary_id
24923
Identifier Type: -
Identifier Source: org_study_id