Odronextamab for Follicular Lymphoma

Overseen By Gottfried Von Keudell, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Gottfried von Keudell, MD PhD

Must be taking: Antivirals

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Infections, Active malignancy, Cardiac conditions, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called odronextamab to determine its safety and effectiveness for people with follicular lymphoma, a type of blood cancer. Participants will receive odronextamab over several cycles and attend regular check-ups to monitor progress and side effects. Suitable candidates for this trial have untreated follicular lymphoma and at least one lymph node larger than 1.5 cm. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or systemic corticosteroids, you may need to stop them 28 days before starting the trial treatment.

Is there any evidence suggesting that odronextamab is likely to be safe for humans?

Research has shown that odronextamab, a monoclonal antibody, has been tested in patients with follicular lymphoma (FL). In earlier studies, patients responded well to odronextamab, even those who had not succeeded with other treatments. Safety data from these studies suggest the treatment is generally well-tolerated. Some patients experienced side effects, but these were mostly manageable.

In a study involving patients with FL who had undergone many previous treatments, odronextamab proved both safe and effective over the long term, suggesting it could be a reliable option. Another trial with previously untreated patients showed encouraging safety results, with many reporting improved quality of life during treatment. While some side effects occurred, they were not severe enough to outweigh the benefits for most patients. This research supports the idea that odronextamab could be a safe treatment option for new patients considering clinical trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for follicular lymphoma, such as chemotherapy and immunotherapy, Odronextamab offers a unique approach by using a bispecific antibody mechanism. This means it can simultaneously bind to both the cancer cells and the immune cells, specifically targeting and activating the patient's own immune system to attack the lymphoma cells more effectively. Researchers are excited about Odronextamab because it could potentially enhance the precision and effectiveness of treatment with fewer side effects compared to traditional therapies.

What evidence suggests that odronextamab might be an effective treatment for Follicular Lymphoma?

Studies have shown that odronextamab looks promising for treating follicular lymphoma. In patients who had already received many treatments and whose cancer had returned or didn't respond to other treatments, odronextamab achieved high complete response rates. Specifically, 73% of these patients saw their cancer completely disappear with the treatment. In patients who had not been treated before, odronextamab showed an objective response rate of 80%, meaning the treatment led to a noticeable reduction in cancer for many people. Overall, the evidence suggests odronextamab could be effective for follicular lymphoma, even in difficult cases. Participants in this trial will receive odronextamab to further evaluate its effectiveness and safety. ^{1 2 3 4 6}

Who Is on the Research Team?

Gottfried Von Keudell, MD, PhD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

Adults with previously untreated Follicular Lymphoma (FL) who are in good health, have a life expectancy over 2 years, and can consent to treatment. They must practice birth control if sexually active. Excluded are those with CNS issues, recent immunosuppressive therapy, certain tumor characteristics or prior lymphoma treatments, uncontrolled infections including HIV/HBV/HCV or COVID-19, other active cancers within 2 years, or potential for curative radiotherapy.

Inclusion Criteria

I agree to use birth control as a sexually active man.

I have hepatitis with controlled viral load.

I need considerable assistance and cannot care for myself.

Exclusion Criteria

I have a brain condition or disease affecting my nervous system.

I have recently been on immunosuppressive therapy.

Not meeting GELF Criteria for high tumor volume

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Odronextamab for up to 6 cycles, each cycle lasting 21 days

18 weeks

In-clinic visits on Days 1, 2, 8, 9, 15, and 16 for Cycle 1; Days 1, 8, and 15 for Cycle 2; Day 1 for Cycles 3-6

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

In-clinic visits every 3 months for 2 years, then annually for 3 years

Long-term follow-up

Annual follow-up by phone to monitor long-term outcomes

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Odronextamab

Trial Overview The trial is testing the safety and effectiveness of odronextamab (a monoclonal antibody) in treating low tumor volume advanced FL. It aims to see how well this new drug works as an initial treatment for patients diagnosed with this type of lymphoma.

How Is the Trial Designed?

Group I: Odronextamab Experimental Treatment 1 Intervention

Enrolled participants will complete: * Baseline visit with imaging and ECG * Cycle 1 (21 day cycle): --Days 1, 2, 8, 9, 15, and 16: Predetermined dose of Odronextamab 1x daily. * Cycle 2 (21 day cycle): * Day 1: tumor biopsy * Days 1, 8, and 15: Predetermined dose of Odronextamab 1x daily. * Cycle 3 through 6 (21 day cycles): * Imaging tests every 3 cycles * Day 1: Predetermined dose of Odronextamab 1x daily. * End of treatment: In-clinic visit with imaging, bone marrow biopsy and aspirate, and ECG. * Follow up: In-clinic visits with ECG and imaging. Visits will be every 3 months for 2 years and then annually for 3 years * Long term follow up: annually by phone * If 5 or fewer participants out of the first 17 participants do not have a complete response to the study drug, then enrollment will stop due to lack of efficacy. Safety will be monitored according to a specified Pocock-type stopping boundary per the protocol.

Who Is Running the Clinical Trial?

Gottfried von Keudell, MD PhD

Lead Sponsor

Trials

2

Recruited

50+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Citations

1. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)03759-1/fulltext

Safety and efficacy of odronextamab in patients with ... Odronextamab achieved high complete response rates with generally manageable safety in patients with heavily pretreated R/R follicular lymphoma.

2. onclive.com onclive.com/view/elm-2-data-display-long-term-efficacy-and-safety-of-odronextamab-in-r-r-follicular-lymphoma

ELM-2 Data Display Long-Term Efficacy and Safety of ... Long-term efficacy and safety data with odronextamab (Ordspono) in heavily pretreated patients with relapsed/refractory follicular lymphoma demonstrate deep ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.7049

Long-term follow-up of the phase 2 ELM-2 study Conclusions: With longer follow-up, odronextamab demonstrated durable responses in heavily pretreated pts with R/R FL from ELM-2, with robust ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0923753424037591

Safety and efficacy of odronextamab in patients with ... Odronextamab achieved high rates of deep response with durability in R/R FL, with 73% of patients attaining complete response.

5. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/4411/529980/Odronextamab-Monotherapy-in-Previously-Untreated

Odronextamab Monotherapy in Previously Untreated Patients ... In the primary analysis of the FL cohort of ELM-2 (NCT03888105), odronextamab treatment achieved an objective response rate (ORR) of 80%, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S215226502500182X

Health-Related Quality of Life With Odronextamab ... Patient-reported outcomes data from ELM-2 complement the efficacy and safety data of odronextamab that support the feasibility of continuing treatment with ...