Imaging study using 64Cu-GRIP B in patients with non-Hodgkin lymphoma receiving CAR-T therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I imaging study evaluates the use of 64Cu-GRIP B Positron Emission Tomography (PET) to detect granzyme B in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) undergoing CD19-directed CAR-T therapy. The study aims to establish the feasibility of this imaging technique and to report on the patterns of granzyme B uptake in tumors, comparing it with conventional imaging methods. Participants will be followed for 12 months post-intervention, with optional tumor biopsies to further assess the treatment response.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Randall Michael, MD — University of California, San Francisco
• Study coordinator: UCSF Hematopoietic Malignancies Clinical Trial Recruitment
• Email: HDFCCC.Heme@ucsf.edu
• Phone: 877-827-3222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.