RECRUITING

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

Conditions

Non Hodgkin Lymphoma CAR-T therapy Imaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-10-23

Study Completion:2027-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06522932

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Disease characteristics, as defined by: 1. Histologically-confirmed relapsed/refractory non-Hodgkin lymphoma 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. Demonstrates adequate organ function as defined below: 1. Absolute neutrophil count \>=1,500/microliter (mcL) 2. Platelets ≥100,000/mcL 3. Total bilirubin within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits. 4. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) \<=3 X institutional upper limit of normal. 5. Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) \<=3 X institutional upper limit of normal 6. Creatinine \<= 1.5 x within institutional upper limit of normal OR creatinine clearance Glomerular filtration rate (GFR) \>= 40 mL/min/1.73 m\^2, calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\^2. 7. Human immunodeficiency virus (HIV)-infected individuals on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial. 8. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 9. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. Individuals with HCV infection who are currently on treatment are eligible if an undetectable HCV viral load is demonstrated. 10. Individuals with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. 11. 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. 12. 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.	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.

Inclusion Criteria

Exclusion Criteria

1. Disease characteristics, as defined by:
1. Histologically-confirmed relapsed/refractory non-Hodgkin lymphoma 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. Demonstrates adequate organ function as defined below:
1. Absolute neutrophil count \>=1,500/microliter (mcL)
2. Platelets ≥100,000/mcL
3. Total bilirubin within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits.
4. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) \<=3 X institutional upper limit of normal.
5. Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) \<=3 X institutional upper limit of normal
6. Creatinine \<= 1.5 x within institutional upper limit of normal OR creatinine clearance Glomerular filtration rate (GFR) \>= 40 mL/min/1.73 m\^2, calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\^2.
7. Human immunodeficiency virus (HIV)-infected individuals on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial.
8. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
9. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. Individuals with HCV infection who are currently on treatment are eligible if an undetectable HCV viral load is demonstrated.
10. Individuals with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
11. 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.
12. 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.

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.

Contacts and Locations

Study Contact

Lily Ju

CONTACT

877-827-3222

lily.ju@ucsf.edu

Principal Investigator

C. Babis Andreadis, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: C. Babis Andreadis

C. Babis Andreadis, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-23

Study Completion Date2027-01-31

Study Record Updates

Study Start Date2024-10-23

Study Completion Date2027-01-31

Terms related to this study

Keywords Provided by Researchers

CAR-T therapy
Imaging

Additional Relevant MeSH Terms

Non Hodgkin Lymphoma