PET Imaging Study of 64Cu-GRIP B for Patients Receiving CD19-directed CAR-T Therapy

Part of paid clinical trials in San Francisco, California.

Sponsor
Michael Randall
Study ID
NCT06522932
Phase
PHASE1
Status
Recruiting
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Conditions

  • Non Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 64Cu-GRIP B — DRUG
    Given IV
  • Positron Emission Tomography (PET) — PROCEDURE
    Undergo imaging procedure
  • Optional tumor biopsy — PROCEDURE
    Undergo optional tumor biopsy

Study Details

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.

Key Dates

First listed
Jul 26, 2024
Start date
Oct 23, 2024
Status verified
Dec 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Proportion of positive tumors at the post-CAR-T scan [ Time Frame: From prior to CAR-T to Day 22 following CAR-T cell, approximately 32 days total ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
UCSF Hematopoietic Malignancies Clinical Trial Recruitment
[email protected]
[email protected]
877-827-3222
Michael Randall, MD (PRINCIPAL_INVESTIGATOR)
Specer Behr, MD (SUB_INVESTIGATOR)

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