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

DLBCL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04566978
• Other study ID #: 19-479
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: September 11, 2020
• Est. completion date: September 11, 2025

Study information

• Verified date: October 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: September 11, 2025
• Est. primary completion date: September 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• DLBCL
• Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

Drug:
• 89Zr-DFO-REGN3767
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.

Diagnostic Test:
• PET/CT
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)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years
Primary	Optimal 89Zr-DFO-REGN3767 mass dose for tumor targeting	Determine the optimal 89Zr-DFO-REGN3767 mass dose for tumor targeting	2 years
Primary	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	2 years
Primary	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.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center