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Non Hodgkin LymphomaPhase 1NCT06522932

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

A Phase 1 study testing 64Cu-GRIP B, Positron Emission Tomography (PET) and Optional tumor biopsy in people with Non Hodgkin Lymphoma, run by Michael Randall at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Non Hodgkin Lymphoma
What is being tested?
64Cu-GRIP B, Positron Emission Tomography (PET) and Optional tumor biopsy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
23 Oct 2024to 31 Jan 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Disease characteristics, as defined by:
  • Histologically-confirmed relapsed/refractory non-Hodgkin lymphoma (NHL) with at least one prior line of therapy.
  • Planned treatment with a commercially available CD19 targeting CAR-T cell product.
  • Willing to undergo post-treatment tumor biopsies and has safely accessible soft tissue lesion.
  • Age >= 18 years.
  • Ability to understand and the willingness to sign a written informed consent document.
Show all 10Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%).
  • Individuals with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
  • 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.
  • 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.

Who cannot join

  • Any condition that, in the opinion of the Principal Investigator, would impair the participant's ability to comply with study procedures.
  • 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.
  • Hypersensitivity to 64Cu-GRIP B or any of its excipients.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

UCSF Hematopoietic Malignancies Clinical Trial Recruitment contact

877-827-3222

HDFCCC.Heme@ucsf.edu

United States1 site, 1 recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    UCSF Hematopoietic Malignancies Clinical Trial Recruitment, HDFCCC.Heme@ucsf.edu

    877-827-3222, cancertrials@ucsf.edu

    Recruiting

Other trials in United States

About this study

Official title: A Phase I/Ib PET Imaging Study of 64Cu-GRIP B, a Radiotracer Targeting Granzyme B, in 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 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.

Read the detailed description

Primary Objectives:

  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.

Being tested
64Cu-GRIP B, Positron Emission Tomography (PET), Optional tumor biopsy
Keywords
CAR-T therapy, Imaging
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.

  • 64Cu-GRIP BDrug

    Also called granzyme B, 64-copper granzyme targeting restricted interaction peptide specific to family member B

    Given IV

  • Positron Emission Tomography (PET)Procedure or surgery

    Also called PET Scan

    Undergo imaging procedure

  • Optional tumor biopsyProcedure or surgery

    Also called Biopsy

    Undergo optional tumor biopsy

Study groups in NCT06522932
Study groupRoleWhat they receive
Cohort 1: 64Cu-GRIP B PET imagingExperimentalParticipants 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.
Receives: Drug: 64Cu-GRIP B; Procedure: Positron Emission Tomography (PET); Procedure: Optional tumor biopsy
Cohort 2: Expansion Phase 64Cu-GRIP B PET imagingExperimentalParticipants 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.
Receives: Drug: 64Cu-GRIP B; Procedure: Positron Emission Tomography (PET); Procedure: Optional tumor biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of positive tumors at the post-CAR-T scan

    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.

    Measured: From prior to CAR-T to Day 22 following CAR-T cell, approximately 32 days total

Secondary outcomes (4)

  1. Mean SUVmax by disease site

    The mean/sd (median and range, if normality assumption does not hold) for intra-tumoral SUVmax within lesions will be descriptively reported, to assess for intra-tumoral heterogeneity and differences in uptake by site of disease.

    Measured: From prior to CAR-T to Day 22 following CAR-T cell, approximately 32 days total

  2. Overall Mean SUVmax by cohort

    The mean/sd (median and range, if normality assumption does not hold) for inter-participant SUVmax within lesions will be descriptively reported, to assess for inter-participant heterogeneity and differences in uptake.

    Measured: From prior to CAR-T to Day 22 following CAR-T cell, approximately 32 days total

  3. Percent of lymphoma lesions detected

    The percentage of lesions detected on conventional imaging that are detected on baseline 64Cu-GRIP B PET will be descriptively reported.

    Measured: From prior to CAR-T to Day 22 following CAR-T cell, approximately 32 days total

  4. Frequency and severity of treatment-emergent adverse events

    Frequency and severity of treatment adverse events following 64Cu-GRIP B injection classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v 5.0).

    Measured: Up to 13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2024
  2. Study start23 Oct 2024
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06522932
Sponsor's protocol ID
24923
Other IDs
NCI-2024-05085
Status last verified
Dec 2025
First submitted
22 Jul 2024
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 64Cu-GRIP B, Positron Emission Tomography (PET) and Optional tumor biopsy in people with Non Hodgkin Lymphoma, run by Michael Randall 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 10 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: looking for participants now, as of the sponsor's last update on 29 Dec 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact UCSF Hematopoietic Malignancies Clinical Trial Recruitment (877-827-3222, HDFCCC.Heme@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06522932.

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 29 Dec 2025.

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