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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called 89Zr-DFO-REGN3767 for individuals with non-Hodgkin's lymphoma, a cancer affecting the lymphatic system. Researchers aim to understand how the body processes this treatment and to determine the optimal dose and timing for PET scans, which visualize cancer in the body. The trial includes different groups receiving various doses to identify the most effective one. Suitable participants have non-Hodgkin's lymphoma with noticeable disease and good kidney function. As an Early Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that 89Zr-DFO-REGN3767 is safe for use in PET scans?

Research has shown that 89Zr-DFO-REGN3767 is under study for its use in PET scans to detect certain cancer cells. Earlier studies focused on safety found that this treatment did not cause any serious side effects, suggesting it is generally safe for humans.

In one initial study, 89Zr-DFO-REGN3767 spread well throughout the body, which is important for obtaining clear images. However, as this trial is in the early stages, the main goal is to understand how the body processes this treatment and to determine the right dosage. This means detailed safety information might still be limited.

Overall, existing studies suggest that this treatment is safe, but since the trial is in its early phase, more information is still being collected. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 89Zr-DFO-REGN3767 for non-Hodgkin's lymphoma because it offers a new approach to tracking and understanding the disease. Unlike traditional treatments that focus on directly attacking cancer cells, this treatment involves a radiolabeled antibody that allows for precise imaging through PET scans. This enables doctors to visualize the distribution and activity of the drug within the body in real-time. By combining imaging with pharmacokinetics, researchers aim to gain insights into how the treatment interacts with lymphoma, potentially leading to more personalized and effective therapies.

What evidence suggests that 89Zr-DFO-REGN3767 could be effective for Non-Hodgkin's Lymphoma?

Research has shown that 89Zr-DFO-REGN3767 is under study for its potential to improve cancer imaging. This trial uses a special antibody that targets LAG-3, a protein linked to cancer growth. Participants will receive different doses of 89Zr-DFO-REGN3767. Studies have found that using this antibody in PET scans can help doctors see cancer cells more clearly. This clarity is important for understanding how well a tumor responds to treatment and making necessary adjustments. While promising evidence suggests it can enhance imaging, more research is needed to confirm its full effectiveness in treating non-Hodgkin's lymphoma. ^{6 7 8 9 10}

Who Is on the Research Team?

Neeta Pandi-Taskar, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. jitc.bmj.com jitc.bmj.com/content/10/8/e004949

Molecular imaging to support cancer immunotherapy Two ongoing studies use [89Zr]-labeled LAG-3 antibody fianlimab (REGN3767) for PET imaging in diffuse large B cell lymphoma and advanced solid ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10769965/

ImmunoPET provides a novel way to visualize the CD103+ ... CD103 ImmunoPET is a promising method for determining tumor-infiltrating lymphocytes (TILs) load and response to ICIs, thereby addressing the lack of reliable ...

3. pdfs.semanticscholar.org pdfs.semanticscholar.org/631e/1eeb29ffa360179961343e2a747fc180a0f1.pdf

Positron Emission Tomography Probes for Imaging ... At present, the safety and diagnostic potential of [89Zr]Zr-DFO-REGN3767 is under eval- uation in a clinical study in patients with diffuse ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/jnumed/early/2020/12/04/jnumed.119.239558.full.pdf

The navigating and de-risking role of 89Zr-immuno-PET in ... In a first clinical study, 89Zr-immuno-PET was applied in 14 patients for imaging of HER2-positive metastatic breast cancer lesions (24). 89Zr- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10199858/

89Zr-immuno-PET using the anti-LAG-3 tracer [89Zr]Zr-BI ... Here, we explored the potential use of the anti-LAG-3 antibody tracer [89Zr]Zr-BI 754111 as a predictive imaging biomarker and investigated its ...

6. jnm.snmjournals.org jnm.snmjournals.org/content/64/supplement_1/P1147

A pilot study of 89Zr-DFO-REGN3767 anti-LAG-3 antibody ... 89Zr-DFO-REGN3767 imaging is feasible, has favorable biodistribution and allows for non-invasive PET targeted imaging and detection of LAG-3 expressing tumor.

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-08024

89Zr-DFO-REGN3767 in PET Scans in People with Diffuse ... This phase I/II trial evaluates 89Zr-DFO-REGN3767 in diagnosing patients with diffuse large B cell lymphoma that has come back (relapsed) or does not ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9798587/

Insights into the tumor microenvironment of B cell lymphoma 89Zr-DFO-REGN3767. NCT05039658, A Phase Ib, Open Label, Randomized, Multicenter Study of the Efficacy and Safety of IBI110 Single Agent and in ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04706715

LAG3 PET Imaging in Advanced Solid Tumors This is an investigator-initiated, single-center, open-label clinical trial designed to evaluate the safety and PK of the PET tracer 89Zr-DFO-REGN3767 in ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10478462/

Targeting LAG-3, TIM-3, and TIGIT for cancer immunotherapy The data from clinical trials of Sym022 used for patients with advanced solid tumors or lymphomas demonstrated no serious adverse drug reactions after the first ...