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89Zr-DFO-REGN3767 PET Scan for Non-Hodgkin's Lymphoma

Phase < 1

Waitlist Available

Led By Neeta Pandi-Taskar, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must have eGFR >50 mL/min/1.73m2.

Measurable disease by Lugano criteria, with at least one lesion outside of the liver

Must not have

Patients who have permanently discontinued anti-cancer immune modulating therapies due to drug-related toxicity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trialwill study the safety and effectiveness of a new drug to understand how it moves through the body.

Who is the study for?

This trial is for people with a type of cancer called Diffuse Large B Cell Lymphoma. They must have measurable disease, at least one lesion outside the liver, and good kidney function (eGFR >50 mL/min/1.73m2). It's not for those who've had severe side effects from immune therapies or haven't recovered from recent cancer treatments.

What is being tested?

Researchers are testing a substance called 89Zr-DFO-REGN3767 in PET scans to see how it's processed by the body, determine the best dose, and find out when is the optimal time to perform PET scanning after its injection.

What are the potential side effects?

Potential side effects may include reactions related to injection such as pain or discomfort at the site of injection, allergic reactions to components of 89Zr-DFO-REGN3767, and any typical risks associated with undergoing PET/CT scans.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function is good.

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I have a cancerous lesion outside my liver that can be measured.

Exclusion Criteria

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

Select...

I stopped taking cancer immune therapy because of its side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Biodistribution of 89Zr-DFO-REGN3767

Optimal 89Zr-DFO-REGN3767 mass dose for tumor targeting

Optimal time for imaging and tumor uptake post 89Zr-DFO-REGN3767 administration

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4Experimental Treatment2 Interventions

Up to 3 participants will be enrolled to receive a total 20mg of 89Zr-DFO-REGN3767 (+REGN3767) total antibody mass for PK and serial imaging with 3 PET/CT scans

Group II: Cohort 3Experimental Treatment2 Interventions

Up to 3 participants will be enrolled to receive a total 10mg of 89Zr-DFO-REGN3767 (+REGN3767) total antibody mass for PK and serial imaging with 3 PET/CT scans

Group III: Cohort 2Experimental Treatment2 Interventions

Up to 3 participants will be enrolled to receive a total 5mg of 89Zr-DFO-REGN3767 (+REGN3767) total antibody mass for PK and serial imaging with 3 PET/CT scans

Group IV: Cohort 1Experimental Treatment2 Interventions

Up to 3 participants will be enrolled to receive a single dose of 89Zr-DFO-REGN3767 (total 2mg antibody mass). Participant to undergo 3 PET/CT scans and concurrent blood draws for PK

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PET/CT

2022

Completed Phase 3

~1300

0 / 3Eligibility criteria met