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NCT06522932 · ClinicalTrials.gov registry record · Phase 1
PET Imaging Study of 64Cu-GRIP B for Patients Receiving CD19-directed CAR-T Therapy
A Phase 1 study of Non-Hodgkin Lymphoma, sponsored by Michael Randall.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT06522932: Recruiting Phase 1 study of Non-Hodgkin Lymphoma, sponsored by Michael Randall.
NCT06522932 is a Phase 1 study of Non-Hodgkin Lymphoma that is actively recruiting participants, run by Michael Randall. The registered enrollment target is 32 participants, below the 167-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06522932, a Phase 1 study of Non-Hodgkin Lymphoma, is actively recruiting participants, sponsored by Michael Randall.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The proportion of known lesions with detectable radiotracer uptake on conventional imaging will be reported along with 95% binomial exact confidence intervals. Tumors will be defined as positive if they are focally avid with maximum standardized uptake value (SUVmax) \>1.5 fold above adjacent background.
Conditions Studied
Interventions
- PROCEDURE Positron Emission Tomography (PET)
- DRUG 64Cu-GRIP B
- PROCEDURE Optional tumor biopsy
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2024-10-23 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 1 |
What NCT06522932 shows while recruiting
NCT06522932 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 167-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Positron Emission Tomography (PET) is the first listed.
NCT06522932 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06522932 about?
NCT06522932 is a clinical study titled "PET Imaging Study of 64Cu-GRIP B for Patients Receiving CD19-directed CAR-T Therapy". 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 recept...
What is the current status of trial NCT06522932?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2024-10-23. Estimated completion is 2027-01-31.
What conditions does trial NCT06522932 study?
This clinical trial studies the following conditions: Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT06522932?
The interventions under investigation include: Positron Emission Tomography (PET) (PROCEDURE), 64Cu-GRIP B (DRUG), Optional tumor biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT06522932?
This trial is sponsored by Michael Randall, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06522932 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06522932's enrollment target sits among peer trials
32 72nd of 106 higher than 35 of 106 other Non-Hodgkin Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Hodgkin Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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