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Completed

NCT Number: NCT04566978

89Zr-DFO-REGN3767 in PET Scans in People With Diffuse Large B Cell Lymphoma (DLBCL)

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

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Key information

Conditions

Large B-cell Lymphoma DLBCL

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A patient must be eligible for DLBCL expansion cohort 9 in study 17-421 and, in addition, meet the following criteria to be eligible for inclusion in the study:

  • Measurable disease by Lugano criteria, with at least one lesion outside of the liver
  • Patients must have eGFR >50 mL/min/1.73m2.

Exclusion criteria

A patient must be eligible for DLBCL expansion cohort 9 in study 17-421 and, in addition, a patient who meets any of the following criteria will be excluded from the study:

  • Patients who have permanently discontinued anti-cancer immune modulating therapies due to drug-related toxicity.
  • Has not yet recovered (i.e. ≤ Grade 1 or baseline) from any acute toxicities from prior anticancer therapy except for laboratory changes as described in inclusion criteria in study 17-421, except as noted. NOTE: Patients with chronic or stable toxicity following approved therapy, such as mild persistent neuropathy, are allowed.
  • Has received radiation therapy within 14 days of first administration of study drug or has not recovered (i.e. ≤ Grade 1 or baseline) from adverse events, except for laboratory changes as described in inclusion criteria, except as noted. NOTE: Patients with chronic or stable toxicity, such as mild persistent neuropathy, are allowed.
  • Women who are pregnant, breastfeeding *Postmenopausal women must be amenorrhoeic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation. Pregnancy testing and screening will be performed per MSK and Department of Radiology standard pregnancy screening guidelines.

Treatment and study plan

89Zr-DFO-REGN3767

Drug

89Zr-DFO-REGN3767 is comprised of the anti-LAG-3 antibody, REGN3767 labeled with the positron-emitter zirconium-89 (89Zr) through the chelator-linker DFO. REGN3767 is an investigational monoclonal antibody that target LAG-3 receptors.

PET/CT

Diagnostic Test

A PET/CT scan extending from top of skull to feet will be performed to determine the biodistribution.

Part A patients will be imaged at three time points post-injection to allow for selection of optimal imaging time and dosimetry determination. For these patients, top of skull to feet scans will be acquired:

  • Within one to four hours following injection of tracer on Day 1
  • 24-72 hours post-injection (Day 2-4)
  • 20-168 hours post-injection (once during days 5-7)

Primary outcomes

  1. Biodistribution of 89Zr-DFO-REGN3767

    Time frame: 2 years

    A PET/CT scan extending from top of skull to feet will be performed to determine the biodistribution of 89Zr-DFO-REGN3767

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

    Time frame: 2 years

    Determine the optimal 89Zr-DFO-REGN3767 mass dose for tumor targeting

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

    Time frame: 2 years

    Determine the optimal time for imaging and tumor uptake post 89Zr-DFO-REGN3767 administration

  4. Tumor lesion uptake of 89Zr-DFO-REGN3767 and correlate with LAG-3 expression by IHC

    Time frame: 2 years

    Evaluate tumor lesion uptake of 89Zr-DFO-REGN3767 and correlate with LAG-3 expression by IHC in tumors will be compared descriptively with other biomarkers of tumor immune environment characterized in biopsies, such as quantitation of IHC score (LAG-3 and / or other immune cell markers), or other biomarker measures.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

A Pilot Study of 89Zr-DFO-REGN3767 Anti LAG-3 Antibody Positron Emission Tomography in Patients With Relapsed/Refractory DLBCL

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 28, 2020
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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