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

Overseen By Neeta Pandi-Taskar, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Anti-cancer immune therapies

Disqualifiers: Pregnancy, Radiation therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Varies by cohort

7 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purposes of this study include: Looking at the way the body absorbs, distributes, and gets rid of 89Zr-DFO-REGN3767 Finding the best dose amount of 89Zr-DFO-REGN3767 Finding the best time for PET scanning after injection of 89Zr-DFO-REGN3767

Research Team

Neeta Pandi-Taskar, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

My kidney function is good.

A patient must be eligible for DLBCL expansion cohort 9 in study 17-421

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

Exclusion Criteria

I haven't had radiation in the last 2 weeks or have recovered from its side effects.

I am not pregnant, breastfeeding, and if applicable, have been postmenopausal for at least 12 months.

I have mostly recovered from side effects of previous cancer treatments, except for mild, stable conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive varying doses of 89Zr-DFO-REGN3767 for PK and serial imaging with PET/CT scans

Varies by cohort

3 PET/CT scans per participant

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• 89Zr-DFO-REGN3767

Trial Overview 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.

Participant Groups

Group I: Cohort 4 Experimental Treatment 2 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 3 Experimental Treatment 2 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 2 Experimental Treatment 2 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 1 Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+