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

Launched by C. BABIS ANDREADIS · Jul 22, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new imaging technique using a special substance called 64Cu-GRIP B to help doctors see how well a specific type of cancer treatment, called CD19-directed CAR-T therapy, is working in patients with non-Hodgkin lymphoma that has come back or is hard to treat. The study aims to find out if this imaging method can detect signs of the treatment's effectiveness by highlighting areas where immune cells are actively fighting the cancer. This is the first time this type of imaging will be used in patients with lymphoma.

To be part of the trial, participants need to be at least 18 years old and have been diagnosed with non-Hodgkin lymphoma that hasn't responded well to previous treatments. They must also be planning to receive CD19-directed CAR-T therapy. Participants will need to agree to some follow-up tests, including biopsies, and show they are in good health overall. The study is currently recruiting, and both men and women can participate. It's important to note that pregnant individuals cannot join this study due to unknown effects on the fetus. Participants will be closely monitored throughout the trial, and their safety is a top priority.

Gender

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Eligibility criteria

• Inclusion 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.
• 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.