Recruiting
Phase 1

64Cu-GRIP B

Sponsor:

Michael Randall

Code:

NCT06522932

Conditions

Non Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

64Cu-GRIP B

Positron Emission Tomography (PET)

Optional tumor biopsy

Study Details

Brief 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.

Conditions

Non Hodgkin Lymphoma

Study ID

NCT06522932

Start date

Oct 23, 2024

Status verified date

Dec, 2025

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Disease characteristics, as defined by:

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:

1. Any condition that, in the opinion of the Principal Investigator, would impair the participant's ability to comply with study procedures.
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.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

64Cu-GRIP B

Given IV

Positron Emission Tomography (PET)

Undergo imaging procedure

Optional tumor biopsy

Undergo optional tumor biopsy

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 and Locations

Central contacts

UCSF Hematopoietic Malignancies Clinical Trial Recruitment

877-827-3222HDFCCC.Heme@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

UCSF Hematopoietic Malignancies Clinical Trial Recruitment

HDFCCC.Heme@ucsf.edu

Principal Investigator:

Michael Randall, MD

More Information

Sponsor

Michael Randall

Last update posted

Dec 29, 2025

Last verified

Dec, 2025

Keywords

  • CAR-T therapy
  • Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Michael Randall on 2025-12-29.