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PET Imaging for Non-Hodgkin's Lymphoma

Phase 1

Recruiting

Led By C. Babis Andreadis, MD

Research Sponsored by C. Babis Andreadis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Demonstrates adequate organ function including: Absolute neutrophil count >=1,500/microliter (mcL), Platelets ≥100,000/mcL, Total bilirubin within normal institutional limits, Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) <=3 X institutional upper limit of normal, Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) <=3 X institutional upper limit of normal, Creatinine <= 1.5 x within institutional upper limit of normal OR creatinine clearance Glomerular filtration rate (GFR) >= 40 mL/min/1.73 m^2, HIV-infected individuals on effective antiretroviral therapy with undetectable viral load within 6 months, Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy, Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured, Individuals with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression, Individuals with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if immediate CNS specific treatment is not required during the first cycle of therapy, Individuals with a prior or concurrent malignancy that does not interfere with the safety or efficacy assessment of the investigational regimen, Participants of childbearing potential must agree to use adequate contraception, Male participants must also agree to use adequate contraception

Willing to undergo post-treatment tumor biopsies and has safely accessible soft tissue lesion

Must not have

Hypersensitivity to 64Cu-GRIP B or any of its excipients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 13 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to use a new imaging technique called positron emission tomography (PET) to study lymphoma patients who are receiving a type of immunotherapy called CD19-directed CAR-T therapy. The

Who is the study for?

This trial is for individuals with relapsed/refractory non-Hodgkin's lymphoma who are undergoing CD19-directed CAR-T therapy. Participants must meet certain health criteria to be eligible, but specific inclusion and exclusion details were not provided.

What is being tested?

The study tests a new PET imaging agent called 64Cu-GRIP B in patients receiving CAR-T therapy. It aims to see if this tracer can identify which tumors will respond well to the treatment by detecting a molecule released by immune cells.

What are the potential side effects?

Potential side effects are not detailed, but may include those associated with PET imaging such as discomfort at injection site or allergic reaction to the tracer. The optional biopsy could cause pain or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to have biopsies after treatment and have a tumor that can be safely biopsied.

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I can do most of my daily activities without help.

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I am 18 years old or older.

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My non-Hodgkin lymphoma has returned or didn't respond to treatment, and I've had at least one treatment before.

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I am scheduled for a CAR-T cell therapy targeting CD19.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am allergic to 64Cu-GRIP B or its ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 13 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 13 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 13 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of positive tumors at the post-CAR-T scan

Secondary study objectives

Frequency and severity of treatment-emergent adverse events

Mean SUVmax by disease site

Overall Mean SUVmax by cohort

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2: Expansion Phase 64Cu-GRIP B PET imagingExperimental Treatment3 Interventions

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.

Group II: Cohort 1: 64Cu-GRIP B PET imagingExperimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography (PET)

2018

Completed Phase 4

~1540

0 / 7Eligibility criteria met