Actively Recruiting
PET Imaging Study of 64Cu-GRIP B for Patients Receiving CD19-directed CAR-T Therapy
Led by Michael Randall · Updated on 2025-12-29
32
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
Sponsors
M
Michael Randall
Lead Sponsor
T
The V Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase I/Ib imaging study of granzyme B, 64-copper granzyme targeting restricted interaction peptide specific to family member B (64Cu-GRIP B) Positron Emission Tomography (PET) in patients with relapsed/refractory non-Hodgkin's lymphoma (NHL) receiving CD19-directed Chimeric antigen receptor T cells (CAR-T) therapy. The proposed study represents the first-ever lymphoma patient imaging studies with 64Cu-GRIP B PET. The tracer is designed to detect extracellular granzyme B as it is secreted by activated immune cells in the tumor microenvironment, which may highlight tumors that will exhibit a durable response to Cluster of Differentiation 19 (CD19)-directed CAR T-cell therapy.
CONDITIONS
Official Title
PET Imaging Study of 64Cu-GRIP B for Patients Receiving CD19-directed CAR-T Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed relapsed or refractory non-Hodgkin lymphoma with at least one prior therapy line
- Planned treatment with a commercially available CD19-targeting CAR-T cell product
- Willingness to undergo post-treatment tumor biopsies with safely accessible soft tissue lesion
- Age 18 years or older
- Ability to understand and sign informed consent
- ECOG performance status less than 2 (Karnofsky score above 60%)
- Treated brain metastases allowed if follow-up imaging shows no progression
- New or progressive brain metastases or leptomeningeal disease allowed if immediate CNS treatment is not required
- Prior or concurrent malignancy allowed if it does not interfere with safety or efficacy assessment
- Agreement to use adequate contraception and barrier protection during and one month after study participation for participants of childbearing potential
You will not qualify if you...
- Any condition impairing ability to comply with study procedures as judged by the Principal Investigator
- Pregnant participants
- Nursing parents must discontinue breastfeeding if receiving 64Cu-GRIP B
- Hypersensitivity to 64Cu-GRIP B or any of its excipients
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
U
UCSF Hematopoietic Malignancies Clinical Trial Recruitment
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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