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Large B-cell LymphomaEarly Phase 1NCT04566978

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

A Early Phase 1 study testing 89Zr-DFO-REGN3767 and PET/CT in people with Large B-cell Lymphoma and DLBCL, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Large B-cell Lymphoma, DLBCL
What is being tested?
89Zr-DFO-REGN3767 and PET/CT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
11 Sep 2020to 21 Mar 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

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

Being tested
89Zr-DFO-REGN3767, PET/CT
Keywords
Large B-cell Lymphoma, DLBCL, Memorial Sloan Kettering Cancer Center, 19-479, 89Zr-DFO-REGN3767, anti LAG-3 antibody

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 89Zr-DFO-REGN3767Drug

    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/CTDiagnostic 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)
Study groups in NCT04566978
Study groupRoleWhat they receive
Cohort 1ExperimentalUp 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
Receives: Drug: 89Zr-DFO-REGN3767; Diagnostic Test: PET/CT
Cohort 2ExperimentalUp 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
Receives: Drug: 89Zr-DFO-REGN3767; Diagnostic Test: PET/CT
Cohort 3ExperimentalUp 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
Receives: Drug: 89Zr-DFO-REGN3767; Diagnostic Test: PET/CT
Cohort 4ExperimentalUp 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
Receives: Drug: 89Zr-DFO-REGN3767; Diagnostic Test: PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biodistribution of 89Zr-DFO-REGN3767

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

    Measured: 2 years

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

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

    Measured: 2 years

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

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

    Measured: 2 years

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

    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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2020
  2. Study start11 Sep 2020
  3. Primary completion21 Mar 2025
  4. Study completion21 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04566978
Sponsor's protocol ID
19-479
Status last verified
Apr 2025
First submitted
15 Sep 2020
Last updated
23 Apr 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 89Zr-DFO-REGN3767 and PET/CT in people with Large B-cell Lymphoma and DLBCL, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biodistribution of 89Zr-DFO-REGN3767 (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04566978.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.

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