Imaging study using 64Cu-GRIP B in patients with non-Hodgkin lymphoma receiving CAR-T therapy
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 study is testing a new imaging method to see if it can help track how well CAR-T therapy is working in patients with relapsed or hard-to-treat non-Hodgkin lymphoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | CAR-T, CAR T, Chimeric antigen receptor |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06522932 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically-confirmed relapsed or refractory non-Hodgkin lymphoma who are scheduled to receive CD19-directed CAR-T therapy.
Not a fit: Patients with non-Hodgkin lymphoma who are not receiving CD19-directed CAR-T therapy or those with ECOG performance status of 2 or higher may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict which patients will respond favorably to CAR-T therapy, potentially improving treatment outcomes.
How similar studies have performed: While this approach is novel in the context of lymphoma imaging, similar imaging techniques have shown promise in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
San Francisco, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.